December 14, 2006
Alcon Announces Voluntary Recall of Systane® Free LIQUID GEL Lubricant Eye Drops in the United States, Including Puerto Rico
Alcon press release on FDA website. General recall of Systane Free. Does not affect other Systane products! Mold found, but no actual incidences of infection reported at this point.
November 7, 2006
Inspire posts larger loss, but still beats Street
Triangle Business Journal. So the analysts were too pessimistic. Good. Fingers crossed, let's hope that Prolacria still has hope too, please.
November 2, 2006
Tranquileyes: Natural relief for dry, red, itchy eyes
PR Web. Thumbs up from us... this is one of the best consumer products on the market for chronic dry eye (particularly overnight) and deserves to be better known.
October 9, 2006
A close look at what's draining your peepers and making them itch
Star-Telegram.com. Pretty decent intro to dry eye for the layperson. Kind of a belated response to the "100 cities etc" thing, with lots of info from the Mayo and the NWHRC.
October 7, 2006
Arizona biotech companies offer hope for canine dry eye
The Phoenix Business Journal. Well, gee, at least someone has hope.
October 5, 2006
Inspire Pharma still in talks with FDA over dry eye drug
Reuters. Nothing, er, new, talk talk talk talk but when are we gonna get this baby approved and on the market?
October 4, 2006
Novagali announces achievement of targeted patient enrolment in Phase III Clinical Trial for Nova22007
PharmaLive. Title says it all. Check our clinical trials page for updates on stuff like this.
September 22, 2006
FDA approves Alcon's Travatan Z
MSN Money. Hey, a glaucoma med without benzalkonium chloride. Progress (hopefully). In its place, "sofzia", an "ionic buffered preservative system". Most significantly, they're admitting that BAK is bad bad bad stuff for people with dry eye.
Thursday, December 14, 2006
Friday, October 20, 2006
Journal Roundup
IN BRIEF
Patient-friendly summary of what's been going on in dry eye research.
I had to blast through this month's abstracts in a hurry but I must say I enjoyed it more than anytime in recent memory! It was relatively light on intense 16-syllable laboratory science and instead included a very welcome infusion of articles on interactions, drug side effects, environmental-related studies and epidemiology. This kind of thing is immensely helpful in raising awareness of the life-impact of dry eye - y'know, patients as people, not just pairs of crackled corneas to douse with drugs now and then.
Here are some examples of articles I enjoyed this month:
Ointment on the lid margins: A study in the American Journal of Ophthalmology studied benefits of basically lining the lid margins with ointment while at work in an attempt to counteract the problems posed for dry eyes by the office environment.
Glaucoma and dry eye: A study in Cornea looked at how many patients with dry eye (ocular surface disease) suffer from glaucoma compared with those who do not have dry eyes. This is an important area as it should encourage more attention by eye doctors to the issues posed by having to manage dry eye and glaucoma at the same time. For example, people with dry eyes may be more vulnerable to harmful effects from preservatives in glaucoma medications.
Rebamipide: The development of new dry eye drugs is excruciatingly slow, or at least seems so when you can't get enough relief from already available remedies. Those who have been following the progress of Rebamipide may be interested in this study in Cornea, which shows improvement to goblet cells, which are responsible for the mucin part of our tears and which for many of us are a key area of concern in anticipating new treatments. The peer review and publication cycle is slow - this report was submitted in early 2005 - but it will at least provide more information than has been available.
Allergy & asthma meds and dry eye: A study in Current Allergy & Asthma Reports discusses the need for increased awareness of dry eye as a side effect of systemic medications, specifically antihistamines. Bravo!!! We need more vigilance in the medical community about this - along with blood pressure medications, acne medications and many more.
"The modern office environment dessicates the eyes?" The title of this article in Indoor Air says it all! We liked this so much we wrote to congratulate the authors.
3-question dry eye survey: Although I think there are already some good dry eye surveys available that help quantify patient symptoms, which in turn helps patient-doctor communication, there is a need for something simpler that can be efficiently used for large-scale studies, and this one sounds like it may work. Now lets get on with the large-scale studies!
STUDY HIGHLIGHTS
Acta Ophthalmologica Scandinavica
STARRY-EYED: The results in the abstract seem to get slightly lost amongst all the 'buts', but... I think they're saying that people with dry eyes have poorer contrast sensitivity and more disability glare than people with healthy eyes, but.... Contrast sensitivity and disability glare in patients with dry eye. Puell et al, 2006 Aug;84(4):527-31. Click here for abstract.
American Journal of Ophthalmology
MORE OF THE SAME (PRESUMABLY). And the more repetition in this area the better, say we. The incidence and risk factors for developing dry eye after myopic LASIK. Savini et al, 2006 Aug;142(2):355-6. Abstract not available online when we went to press.
GOOPING UP THOSE LIDS: This is an interesting one: Take an ointment and apply it all along the lid margin rather than in the eye. The claim of improved symptoms is easy to believe - we've known many patients who do this regularly. We've got our concerns about ointments in general though and we'd like to see more long-term studies of what they do to ocular surface wettability. Successful tear lipid layer treatment for refractory dry eye in office workers by low-dose lipid application on the full-length eyelid margin. Goto et al, Am J Ophthalmol. 2006 Aug;142(2):264-270.e1. Click here for abstract.
DOESN'T GET MUCH SIMPLER THAN THIS : A 3-question dry eye survey is apparently accurate enough for use in epidemiological studies. Now let's get cracking on those studies! Validation and repeatability of a short questionnaire for dry eye syndrome. Gulati et al, 2006 Jul;142(1):125-131. Click here for abstract.
Archivos de la Sociedad Espanola de Oftalmologia
INFOMERCIAL BREAK for Systane... at least that's what we assume this is (haven't read the full article as we don't have a subscription). [Reduction of corneal permeability in patients treated with HP-guar: a fluorophotometric study.] Cervan-Lopez et al, 2006 Jun;81(6):327-32. Click here for abstract.
Cornea
MORE GLAUCOMA WITH DRY EYE: Ha - we thought it was the other way around, since so many people on glaucoma meds seem to get ocular surface irritation from the preservatives. This is an interesting retrospective study at the University of Cincinnati. We couldn't agree more with the last sentence in the results stating that "This information warrants increased attention to treatment and management of OSD and concurrent glaucoma." Incidence and prevalence of glaucoma in severe ocular surface disease. Tsai et al, Cornea. 2006 Jun;25(5):530-2. Click here for abstract.
AND WHAT'S GOOD ENOUGH FOR RODENTS MUST BE GOOD ENOUGH FOR US: Or at least our goblet cells. This is a study on Rebamipide completed in 2005. Rebamipide is in Phase III clinicals at present and we are hoping they will get this one approved promptly. OPC-12759 increases proliferation of cultured rat conjunctival goblet cells. Rios et al, 2006 Jun;25(5):573-81. Click here for abstract.
Current Allergy and Asthma Reports
ABOUT THAT ANTIHISTAMINE, DOC: I was very happy to see this one, as a reminder that patients need to be made aware of the potential side effects of non-ocular drugs they are taking. Can't tell you how many times I've had site visitors who had no idea their allergy or blood pressure meds might be related to their dry eye woes. Ocular toxicity of systemic asthma and allergy treatments. L Bielory, 2006 Jul;6(4):299-305. Click here for abstract.
Graefe's Archive for Clinical and Experimental Ophthalmology
EPITHELIAL CELL DENSITIES AND SUCHLIKE: This study compares corneal thickness, epithelial cell density and other corneal properties in the central and peripheral cornea of 3 groups of patients (incl. aqueous deficient and some with lagophthalmos) versus controls. In vivo confocal laser scanning microscopy of the cornea in dry eye. Erdelyi et al, 2006 Jul 28; [Epub ahead of print]. Click here for abstract.
Indoor Air
AND ALL COMPUTER USERS SAID, AMEN: Well, the cynics amongst us muttered something more like "That'll be the day." Look at this: "The workplace, thermal conditions, and work schedule (including breaks) should be planned in such a way to help maintain a normal eye blink frequency to minimize alterations of the pre-corneal tear film." Yes, yes, yes! The modern office environment desiccates the eyes? Wolkoff et al, 2006 Aug;16(4):258-65. Click here for abstract.
Infection and Immunity
MORE DETECTIVE WORK: One of the latest in efforts to understand components of the tear film and where they do and don't reside, this discusses GP340. Nothing jumped off the page at me as hugely exciting but you never know when one of these might turn into a clue to an effective new treatment. Glycoprotein 340 in normal human ocular surface tissues and tear film. Jumblatt et al, 2006 Jul;74(7):4058-63. Click here for abstract.
Investigative Ophthalmology & Visual Science
ANOTHER ONE OF THOSE: Sigh, all the right names, again, and again I'd just like to see it in words of fewer than ten syllables because this kind of science is just way over my head without some attempt at translation into English. Will somebody somewhere develop a vision for making this stuff more accessible to the rest of us? Desiccating stress stimulates expression of matrix metalloproteinases by the corneal epithelium. Corrales et al, 2006 Aug;47(8):3293-302. Click here for abstract.
HOW TO TELL GOOD TEARS FROM BAD: Especially since you can't ask the rabbits (even New Zealand Whites - and by the by, I gotta love people who are precise enough to identify the make and model of the rabbits in their abstract). But returning to the point, there seem to be some type(s) of phospholipids present only in dry eye tears. Identification and comparison of the polar phospholipids in normal and dry eye rabbit tears by maldi-tof mass spectrometry. Ham et al, 2006 Aug;47(8):3330-8. Click here for abstract.
Journal of Biomedical Materials Research (Part B, Applied Biomaterials)
HMMM - DEFINITELY ONE TO WATCH: "As a therapeutic strategy, we are working to develop a bioengineered tear secretory system...." Tissue-engineered tear secretory system: Functional lacrimal gland acinar cells cultured on matrix protein-coated substrata. Selvam et al, 2006 Jul 18; [Epub ahead of print]. Click here for abstract.
Journal of Biomedical Optics
YES, THEY REALLY ARE DIFFERENT. It's hard to get excited about an abstract establishing that the tear film in dry eyes and lens wearers differs from controls - or about a last sentence stating that artificial tears apparently help. Interferometric measurements of dynamic changes of tear film. Szczesna et al, 2006 May-Jun;11(3):34028. Click here for abstract.
Journal of Cataract & Refractive Surgery
TOO OUTRAGED TO THINK UP A CATCHY BLURB: A study in this month's JCRS challenges the FDA's listing of auto-immune diseases as a contraindication to LASIK. Valid points are made that "not all auto-immune diseases are equal", and the authors openly acknowledge the limited scope of what they are attempting (establishing incidence of severe complications only - they did NOT review any data on visual outcomes or dry eye) but even as a preliminary step towards removing thihttp://www2.blogger.com/img/gl.link.gifs contraindication this is of great concern to us. The overall gist and this section left me foaming at the mouth: "One limitation of our study is that we do not have data on the incidence or severity of dry eye or dry-eye complaints... LASIK is associated with dry eye signs and symptoms. The high incidence and variability of dry-eye symptoms after LASIK in normal eyes and the retrospective nature of our study would have made any conclusions about dry eye unreliable." Great. Just great. Let's keep the lawyers at bay by establishing that LASIK may be just tootin' fine for many auto-immune patients, on the basis that so many people get dry eye after LASIK anyway that we really don't have a clue if having RA, lupus or Sjogrens makes it worse. Laser in situ keratomileusis in patients with autoimmune diseases, Smith et al, JCRS 2006; 32:1292-1295. for abstract.
Journal Francais d'Ophtalmologie
OBOY, A NEW DIAGNOSTIC TOY! (Uh, wassup with the pet name?) The Video Tearscope ("Vi-Te") sounds like a very interesting development in non-invasive tear film diagnostics. Hope to see more on this as the research progresses. The Video Tearscope: a new method for evaluating lacrimal film in vivo, Ounnoughene et al, J Fr Ophth 2006 May;29(5):476-84. Click here for abstract.
Journal of Rheumatology
ANOTHER MARKER FOR SJOGRENS? The cumulative numbers and 'respectivelys' in the abstract are a little dizzying but there are some interesting results here in identifying activation markers of Sjogrens Syndrome. Comparative analysis of autoantibodies against a-fodrin in serum, tear fluid, and saliva from patients with Sjogren's syndrome. Yavuz et al, 2006 Jul;33(7):1289-92. Click here for abstract.
Journal of Zhejiang University (Science, B)
YA THINK? Golly, I'm sure no one ever noticed THIS before: Steroids make dry eyes feel better pretty durned fast. Maybe in a few years someone will discover a connection between steroid use and IOP - if we're really lucky. A clinical study of the efficacy of topical corticosteroids on dry eye. Yang et al, 2006 Aug;7(8):675-8. Click here for abstract.
Klinika Oczna
YADA... ON SECOND THOUGHT, NADA of value adhttp://www2.blogger.com/img/gl.link.gifded here. [The evaluation of tears secretion after refractive surgery] Mrukwa-Kominek et al, 2006;108(1-3):73-7. Click here for abstract (translated). Article in Polish.
Ophthalmologica
I COUNTED EVERYTHING EXCEPT THE NUMBERS: Gulp. Back to the drawing board, please. How can you possibly attempt to gauge the cost of treating dry eye syndrome while excluding the primary forms of both treatment (artificial tear supplementation) and care (self-care and optometrists)? Worse, how could you possibly come up with a set of criteria that would determine fewer than 0.1% of the population have dry eye, even if you were trying hard to get it wrong? Worst, when you know it's wrong and are happy to admit it, why bother publishing it? The annual cost of dry eye syndrome in France, Germany, Italy, Spain, Sweden and the United kingdom among patients managed by ophthalmologists. Clegg et al, 06 Aug;13(4):263-74. for abstract.
Patient-friendly summary of what's been going on in dry eye research.
I had to blast through this month's abstracts in a hurry but I must say I enjoyed it more than anytime in recent memory! It was relatively light on intense 16-syllable laboratory science and instead included a very welcome infusion of articles on interactions, drug side effects, environmental-related studies and epidemiology. This kind of thing is immensely helpful in raising awareness of the life-impact of dry eye - y'know, patients as people, not just pairs of crackled corneas to douse with drugs now and then.
Here are some examples of articles I enjoyed this month:
Ointment on the lid margins: A study in the American Journal of Ophthalmology studied benefits of basically lining the lid margins with ointment while at work in an attempt to counteract the problems posed for dry eyes by the office environment.
Glaucoma and dry eye: A study in Cornea looked at how many patients with dry eye (ocular surface disease) suffer from glaucoma compared with those who do not have dry eyes. This is an important area as it should encourage more attention by eye doctors to the issues posed by having to manage dry eye and glaucoma at the same time. For example, people with dry eyes may be more vulnerable to harmful effects from preservatives in glaucoma medications.
Rebamipide: The development of new dry eye drugs is excruciatingly slow, or at least seems so when you can't get enough relief from already available remedies. Those who have been following the progress of Rebamipide may be interested in this study in Cornea, which shows improvement to goblet cells, which are responsible for the mucin part of our tears and which for many of us are a key area of concern in anticipating new treatments. The peer review and publication cycle is slow - this report was submitted in early 2005 - but it will at least provide more information than has been available.
Allergy & asthma meds and dry eye: A study in Current Allergy & Asthma Reports discusses the need for increased awareness of dry eye as a side effect of systemic medications, specifically antihistamines. Bravo!!! We need more vigilance in the medical community about this - along with blood pressure medications, acne medications and many more.
"The modern office environment dessicates the eyes?" The title of this article in Indoor Air says it all! We liked this so much we wrote to congratulate the authors.
3-question dry eye survey: Although I think there are already some good dry eye surveys available that help quantify patient symptoms, which in turn helps patient-doctor communication, there is a need for something simpler that can be efficiently used for large-scale studies, and this one sounds like it may work. Now lets get on with the large-scale studies!
STUDY HIGHLIGHTS
Acta Ophthalmologica Scandinavica
STARRY-EYED: The results in the abstract seem to get slightly lost amongst all the 'buts', but... I think they're saying that people with dry eyes have poorer contrast sensitivity and more disability glare than people with healthy eyes, but.... Contrast sensitivity and disability glare in patients with dry eye. Puell et al, 2006 Aug;84(4):527-31. Click here for abstract.
American Journal of Ophthalmology
MORE OF THE SAME (PRESUMABLY). And the more repetition in this area the better, say we. The incidence and risk factors for developing dry eye after myopic LASIK. Savini et al, 2006 Aug;142(2):355-6. Abstract not available online when we went to press.
GOOPING UP THOSE LIDS: This is an interesting one: Take an ointment and apply it all along the lid margin rather than in the eye. The claim of improved symptoms is easy to believe - we've known many patients who do this regularly. We've got our concerns about ointments in general though and we'd like to see more long-term studies of what they do to ocular surface wettability. Successful tear lipid layer treatment for refractory dry eye in office workers by low-dose lipid application on the full-length eyelid margin. Goto et al, Am J Ophthalmol. 2006 Aug;142(2):264-270.e1. Click here for abstract.
DOESN'T GET MUCH SIMPLER THAN THIS : A 3-question dry eye survey is apparently accurate enough for use in epidemiological studies. Now let's get cracking on those studies! Validation and repeatability of a short questionnaire for dry eye syndrome. Gulati et al, 2006 Jul;142(1):125-131. Click here for abstract.
Archivos de la Sociedad Espanola de Oftalmologia
INFOMERCIAL BREAK for Systane... at least that's what we assume this is (haven't read the full article as we don't have a subscription). [Reduction of corneal permeability in patients treated with HP-guar: a fluorophotometric study.] Cervan-Lopez et al, 2006 Jun;81(6):327-32. Click here for abstract.
Cornea
MORE GLAUCOMA WITH DRY EYE: Ha - we thought it was the other way around, since so many people on glaucoma meds seem to get ocular surface irritation from the preservatives. This is an interesting retrospective study at the University of Cincinnati. We couldn't agree more with the last sentence in the results stating that "This information warrants increased attention to treatment and management of OSD and concurrent glaucoma." Incidence and prevalence of glaucoma in severe ocular surface disease. Tsai et al, Cornea. 2006 Jun;25(5):530-2. Click here for abstract.
AND WHAT'S GOOD ENOUGH FOR RODENTS MUST BE GOOD ENOUGH FOR US: Or at least our goblet cells. This is a study on Rebamipide completed in 2005. Rebamipide is in Phase III clinicals at present and we are hoping they will get this one approved promptly. OPC-12759 increases proliferation of cultured rat conjunctival goblet cells. Rios et al, 2006 Jun;25(5):573-81. Click here for abstract.
Current Allergy and Asthma Reports
ABOUT THAT ANTIHISTAMINE, DOC: I was very happy to see this one, as a reminder that patients need to be made aware of the potential side effects of non-ocular drugs they are taking. Can't tell you how many times I've had site visitors who had no idea their allergy or blood pressure meds might be related to their dry eye woes. Ocular toxicity of systemic asthma and allergy treatments. L Bielory, 2006 Jul;6(4):299-305. Click here for abstract.
Graefe's Archive for Clinical and Experimental Ophthalmology
EPITHELIAL CELL DENSITIES AND SUCHLIKE: This study compares corneal thickness, epithelial cell density and other corneal properties in the central and peripheral cornea of 3 groups of patients (incl. aqueous deficient and some with lagophthalmos) versus controls. In vivo confocal laser scanning microscopy of the cornea in dry eye. Erdelyi et al, 2006 Jul 28; [Epub ahead of print]. Click here for abstract.
Indoor Air
AND ALL COMPUTER USERS SAID, AMEN: Well, the cynics amongst us muttered something more like "That'll be the day." Look at this: "The workplace, thermal conditions, and work schedule (including breaks) should be planned in such a way to help maintain a normal eye blink frequency to minimize alterations of the pre-corneal tear film." Yes, yes, yes! The modern office environment desiccates the eyes? Wolkoff et al, 2006 Aug;16(4):258-65. Click here for abstract.
Infection and Immunity
MORE DETECTIVE WORK: One of the latest in efforts to understand components of the tear film and where they do and don't reside, this discusses GP340. Nothing jumped off the page at me as hugely exciting but you never know when one of these might turn into a clue to an effective new treatment. Glycoprotein 340 in normal human ocular surface tissues and tear film. Jumblatt et al, 2006 Jul;74(7):4058-63. Click here for abstract.
Investigative Ophthalmology & Visual Science
ANOTHER ONE OF THOSE: Sigh, all the right names, again, and again I'd just like to see it in words of fewer than ten syllables because this kind of science is just way over my head without some attempt at translation into English. Will somebody somewhere develop a vision for making this stuff more accessible to the rest of us? Desiccating stress stimulates expression of matrix metalloproteinases by the corneal epithelium. Corrales et al, 2006 Aug;47(8):3293-302. Click here for abstract.
HOW TO TELL GOOD TEARS FROM BAD: Especially since you can't ask the rabbits (even New Zealand Whites - and by the by, I gotta love people who are precise enough to identify the make and model of the rabbits in their abstract). But returning to the point, there seem to be some type(s) of phospholipids present only in dry eye tears. Identification and comparison of the polar phospholipids in normal and dry eye rabbit tears by maldi-tof mass spectrometry. Ham et al, 2006 Aug;47(8):3330-8. Click here for abstract.
Journal of Biomedical Materials Research (Part B, Applied Biomaterials)
HMMM - DEFINITELY ONE TO WATCH: "As a therapeutic strategy, we are working to develop a bioengineered tear secretory system...." Tissue-engineered tear secretory system: Functional lacrimal gland acinar cells cultured on matrix protein-coated substrata. Selvam et al, 2006 Jul 18; [Epub ahead of print]. Click here for abstract.
Journal of Biomedical Optics
YES, THEY REALLY ARE DIFFERENT. It's hard to get excited about an abstract establishing that the tear film in dry eyes and lens wearers differs from controls - or about a last sentence stating that artificial tears apparently help. Interferometric measurements of dynamic changes of tear film. Szczesna et al, 2006 May-Jun;11(3):34028. Click here for abstract.
Journal of Cataract & Refractive Surgery
TOO OUTRAGED TO THINK UP A CATCHY BLURB: A study in this month's JCRS challenges the FDA's listing of auto-immune diseases as a contraindication to LASIK. Valid points are made that "not all auto-immune diseases are equal", and the authors openly acknowledge the limited scope of what they are attempting (establishing incidence of severe complications only - they did NOT review any data on visual outcomes or dry eye) but even as a preliminary step towards removing thihttp://www2.blogger.com/img/gl.link.gifs contraindication this is of great concern to us. The overall gist and this section left me foaming at the mouth: "One limitation of our study is that we do not have data on the incidence or severity of dry eye or dry-eye complaints... LASIK is associated with dry eye signs and symptoms. The high incidence and variability of dry-eye symptoms after LASIK in normal eyes and the retrospective nature of our study would have made any conclusions about dry eye unreliable." Great. Just great. Let's keep the lawyers at bay by establishing that LASIK may be just tootin' fine for many auto-immune patients, on the basis that so many people get dry eye after LASIK anyway that we really don't have a clue if having RA, lupus or Sjogrens makes it worse. Laser in situ keratomileusis in patients with autoimmune diseases, Smith et al, JCRS 2006; 32:1292-1295. for abstract.
Journal Francais d'Ophtalmologie
OBOY, A NEW DIAGNOSTIC TOY! (Uh, wassup with the pet name?) The Video Tearscope ("Vi-Te") sounds like a very interesting development in non-invasive tear film diagnostics. Hope to see more on this as the research progresses. The Video Tearscope: a new method for evaluating lacrimal film in vivo, Ounnoughene et al, J Fr Ophth 2006 May;29(5):476-84. Click here for abstract.
Journal of Rheumatology
ANOTHER MARKER FOR SJOGRENS? The cumulative numbers and 'respectivelys' in the abstract are a little dizzying but there are some interesting results here in identifying activation markers of Sjogrens Syndrome. Comparative analysis of autoantibodies against a-fodrin in serum, tear fluid, and saliva from patients with Sjogren's syndrome. Yavuz et al, 2006 Jul;33(7):1289-92. Click here for abstract.
Journal of Zhejiang University (Science, B)
YA THINK? Golly, I'm sure no one ever noticed THIS before: Steroids make dry eyes feel better pretty durned fast. Maybe in a few years someone will discover a connection between steroid use and IOP - if we're really lucky. A clinical study of the efficacy of topical corticosteroids on dry eye. Yang et al, 2006 Aug;7(8):675-8. Click here for abstract.
Klinika Oczna
YADA... ON SECOND THOUGHT, NADA of value adhttp://www2.blogger.com/img/gl.link.gifded here. [The evaluation of tears secretion after refractive surgery] Mrukwa-Kominek et al, 2006;108(1-3):73-7. Click here for abstract (translated). Article in Polish.
Ophthalmologica
I COUNTED EVERYTHING EXCEPT THE NUMBERS: Gulp. Back to the drawing board, please. How can you possibly attempt to gauge the cost of treating dry eye syndrome while excluding the primary forms of both treatment (artificial tear supplementation) and care (self-care and optometrists)? Worse, how could you possibly come up with a set of criteria that would determine fewer than 0.1% of the population have dry eye, even if you were trying hard to get it wrong? Worst, when you know it's wrong and are happy to admit it, why bother publishing it? The annual cost of dry eye syndrome in France, Germany, Italy, Spain, Sweden and the United kingdom among patients managed by ophthalmologists. Clegg et al, 06 Aug;13(4):263-74. for abstract.
Friday, September 1, 2006
Drug Pipeline
What's in the Pipeline
On their way to pharmacies (sooner or later)?
ALLERGAN/OPTIF: According to the 8/4 quarterly investor conference call, this new artificial tear is due out this quarter. Click here for webcast & PDF transcript.
SINCLAIR PHARMA/SPHP700: Sinclair recently announced this was approved by the MHRA as Medical Device Class I (Sterile) and will be marketed as a prescription drug for the dry eye market. We're waiting for Sinclair to get back to us about the actual ingredients. From the limited information available it sounds like a glorified artificial tear, but maybe they will surprise us. Click here for a PDF copy of the full press release. Update 8/14: They are not releasing any more information about the mechanism of the drug and reportedly may not have it actually on the market for up to two years.
Teetering on the brink (of what, we don't know)
INSPIRE/"PROLACRIA" (DIQUAFOSOL TETRASODIUM): The most recent official news is as newsless as the last few rounds: "No substantive updates" was the characterization in the conference call on Aug 8th. Having twice fallen short of FDA blessings, hopefully by their next quarterly call we'll know whether we're looking at 'third time's a charm' or, um, 'three strikes and you're out biiiiiig bucks'. If the former, it sounds like they will go down the same path as Restasis with a co-promotion arrangement.
In Phase III Clinicals
OTSUKA-NOVARTIS/REBAMIPIDE: A study completed in 2005 was published this month in Cornea, which demostrated that it stimulates proliferation of conjunctival goblet cells in primary culture. Let's hope it works for humans and not just rats. Click here for abstract. Otherwise, no new news. Phase III clinical trials ongoing. This still seems to be the furthest along of anything in the current pipeline (unless Diquafosol/Prolacria surprises us) especially as androgen tears seem to have ground to a halt. Click here for initial screening checklist and list of study centers.
NOVAGALI/NOVA22007: (No updates this month) Cyclosporine emulsion. Recently started Phase III clinicals after obtaining new funding. Click here for most recent press release.
NASCENT/ iDESTRIN (NP50301): (No updates this month) Estrogen ester compound (topical eyedrop). Phase IIb clinical completed, now all we need is money to move forward. Latest report was in early January (click here for press release) stating good results from Phase IIb with "no drug related serious adverse effects". Click here for Nascent's page.
SENJU-ISTA/ECABET SODIUM: (No updates this month) Mucin secretagogue. Expecting to start Phase III trials in 2007, having reported positive results from Phase IIb studies in February 06. Ista claim that this is the first drug to show efficacy in clinicals against both signs and symptoms of dry eye. Click here for most recent press release and here for ISTA's main (albeit very outdated) page on this.
In Phase II clinicals
NOVARTIS / PIMECROLIMUS (AMS981): (No updates this month) Recruiting for Phase II clinicals. Click here for more info (or patients interested in signing up click here).
LANTIBIO/MOLI1901: (No updates this month)Cystic fibrosis drug being attempted as a dry eye treatment. Currently undergoing Phase II trials in the US following positive results in european Phase I studies. Click here for a, uh, colorful graphic about the mechanism of action.
On the horizon (maybe)
SENJU/LACRITIN: (No updates this month) It's very early stages yet but we've been keeping an eye on this for well over a year and think it's one of the most interesting and promising things coming down the pipeline. Some results of rabbit eye studies presented at ARVO recently. Click here for some updates & abstract from ARVO posted in Dry Eye Talk.
CAN-FITE/BIOPHARMA/CF-101: (No updates this month) CF101 is currently in clinical trials as a treatment for rheumatoid arthritis. The company has announced that it will shortly initiate another clinical study to test the drug's efficacy in treating dry eye symptoms. Click here for more.
OTHERA/OT-551: (No updates this month) This is in Phase II clinical for preventing cataracts in patients who have undergone vitrectomy. Othera has stated they expect to begin Phase II clinicals for two additional indications, AMD and dry eye syndrome, next year. Click here for more.
PAI-2: (No updates this month) Research being done at University of Pennsylvania and Temple University; data presented at ARVO recently. Not a whole lot of info but it sounds interesting. Click here for more.
Dead? In a coma? Dazed? Speak to me, baby
ALLERGAN/ANDROGEN TEARS: Frustration is mounting at the mixed signals about this. We heard that excellent data were presented at ARVO, and we heard that the study is progressing. On the other hand, from other sources we've heard that Allergan have all but given up on this. Indeed their total silence about androgen on their website and on their 2Q conference call on Aug. 4th are not promising. We'd like to link to something, but there doesn't seem to be anything to link to. If this project is killed, we darned well want to know why, because we know many patients have benefitted from this kind of therapy. (Anyone listening?) If the current incarnation is dead in the water, we will hope for a reincarnation.
On their way to pharmacies (sooner or later)?
ALLERGAN/OPTIF: According to the 8/4 quarterly investor conference call, this new artificial tear is due out this quarter. Click here for webcast & PDF transcript.
SINCLAIR PHARMA/SPHP700: Sinclair recently announced this was approved by the MHRA as Medical Device Class I (Sterile) and will be marketed as a prescription drug for the dry eye market. We're waiting for Sinclair to get back to us about the actual ingredients. From the limited information available it sounds like a glorified artificial tear, but maybe they will surprise us. Click here for a PDF copy of the full press release. Update 8/14: They are not releasing any more information about the mechanism of the drug and reportedly may not have it actually on the market for up to two years.
Teetering on the brink (of what, we don't know)
INSPIRE/"PROLACRIA" (DIQUAFOSOL TETRASODIUM): The most recent official news is as newsless as the last few rounds: "No substantive updates" was the characterization in the conference call on Aug 8th. Having twice fallen short of FDA blessings, hopefully by their next quarterly call we'll know whether we're looking at 'third time's a charm' or, um, 'three strikes and you're out biiiiiig bucks'. If the former, it sounds like they will go down the same path as Restasis with a co-promotion arrangement.
In Phase III Clinicals
OTSUKA-NOVARTIS/REBAMIPIDE: A study completed in 2005 was published this month in Cornea, which demostrated that it stimulates proliferation of conjunctival goblet cells in primary culture. Let's hope it works for humans and not just rats. Click here for abstract. Otherwise, no new news. Phase III clinical trials ongoing. This still seems to be the furthest along of anything in the current pipeline (unless Diquafosol/Prolacria surprises us) especially as androgen tears seem to have ground to a halt. Click here for initial screening checklist and list of study centers.
NOVAGALI/NOVA22007: (No updates this month) Cyclosporine emulsion. Recently started Phase III clinicals after obtaining new funding. Click here for most recent press release.
NASCENT/ iDESTRIN (NP50301): (No updates this month) Estrogen ester compound (topical eyedrop). Phase IIb clinical completed, now all we need is money to move forward. Latest report was in early January (click here for press release) stating good results from Phase IIb with "no drug related serious adverse effects". Click here for Nascent's page.
SENJU-ISTA/ECABET SODIUM: (No updates this month) Mucin secretagogue. Expecting to start Phase III trials in 2007, having reported positive results from Phase IIb studies in February 06. Ista claim that this is the first drug to show efficacy in clinicals against both signs and symptoms of dry eye. Click here for most recent press release and here for ISTA's main (albeit very outdated) page on this.
In Phase II clinicals
NOVARTIS / PIMECROLIMUS (AMS981): (No updates this month) Recruiting for Phase II clinicals. Click here for more info (or patients interested in signing up click here).
LANTIBIO/MOLI1901: (No updates this month)Cystic fibrosis drug being attempted as a dry eye treatment. Currently undergoing Phase II trials in the US following positive results in european Phase I studies. Click here for a, uh, colorful graphic about the mechanism of action.
On the horizon (maybe)
SENJU/LACRITIN: (No updates this month) It's very early stages yet but we've been keeping an eye on this for well over a year and think it's one of the most interesting and promising things coming down the pipeline. Some results of rabbit eye studies presented at ARVO recently. Click here for some updates & abstract from ARVO posted in Dry Eye Talk.
CAN-FITE/BIOPHARMA/CF-101: (No updates this month) CF101 is currently in clinical trials as a treatment for rheumatoid arthritis. The company has announced that it will shortly initiate another clinical study to test the drug's efficacy in treating dry eye symptoms. Click here for more.
OTHERA/OT-551: (No updates this month) This is in Phase II clinical for preventing cataracts in patients who have undergone vitrectomy. Othera has stated they expect to begin Phase II clinicals for two additional indications, AMD and dry eye syndrome, next year. Click here for more.
PAI-2: (No updates this month) Research being done at University of Pennsylvania and Temple University; data presented at ARVO recently. Not a whole lot of info but it sounds interesting. Click here for more.
Dead? In a coma? Dazed? Speak to me, baby
ALLERGAN/ANDROGEN TEARS: Frustration is mounting at the mixed signals about this. We heard that excellent data were presented at ARVO, and we heard that the study is progressing. On the other hand, from other sources we've heard that Allergan have all but given up on this. Indeed their total silence about androgen on their website and on their 2Q conference call on Aug. 4th are not promising. We'd like to link to something, but there doesn't seem to be anything to link to. If this project is killed, we darned well want to know why, because we know many patients have benefitted from this kind of therapy. (Anyone listening?) If the current incarnation is dead in the water, we will hope for a reincarnation.
Thursday, August 31, 2006
Journal Roundup
NEW! In brief
Patient-friendly highlights of recently published studies
I had to blast through this month's abstracts in a hurry but I must say I enjoyed it more than anytime in recent memory! It was relatively light on intense 16-syllable laboratory science and instead included a very welcome infusion of articles on interactions, drug side effects, environmental-related studies and epidemiology. This kind of thing is immensely helpful in raising awareness of the life-impact of dry eye - y'know, patients as people, not just pairs of crackled corneas to douse with drugs now and then.
Here are some examples of articles I enjoyed this month:
Ointment on the lid margins: A study in the American Journal of Ophthalmology studied benefits of basically lining the lid margins with ointment while at work in an attempt to counteract the problems posed for dry eyes by the office environment.
Glaucoma and dry eye: A study in Cornea looked at how many patients with dry eye (ocular surface disease) suffer from glaucoma compared with those who do not have dry eyes. This is an important area as it should encourage more attention by eye doctors to the issues posed by having to manage dry eye and glaucoma at the same time. For example, people with dry eyes may be more vulnerable to harmful effects from preservatives in glaucoma medications.
Rebamipide: The development of new dry eye drugs is excruciatingly slow, or at least seems so when you can't get enough relief from already available remedies. Those who have been following the progress of Rebamipide may be interested in this study in Cornea, which shows improvement to goblet cells, which are responsible for the mucin part of our tears and which for many of us are a key area of concern in anticipating new treatments. The peer review and publication cycle is slow - this report was submitted in early 2005 - but it will at least provide more information than has been available.
Allergy & asthma meds and dry eye: A study in Current Allergy & Asthma Reports discusses the need for increased awareness of dry eye as a side effect of systemic medications, specifically antihistamines. Bravo!!! We need more vigilance in the medical community about this - along with blood pressure medications, acne medications and many more.
"The modern office environment dessicates the eyes?" The title of this article in Indoor Air says it all! We liked this so much we wrote to congratulate the authors.
3-question dry eye survey: Although I think there are already some good dry eye surveys available that help quantify patient symptoms, which in turn helps patient-doctor communication, there is a need for something simpler that can be efficiently used for large-scale studies, and this one sounds like it may work. Now lets get on with the large-scale studies!
Study highlights
Acta Ophthalmologica Scandinavica
STARRY-EYED: The results in the abstract seem to get slightly lost amongst all the 'buts', but... I think they're saying that people with dry eyes have poorer contrast sensitivity and more disability glare than people with healthy eyes, but.... Contrast sensitivity and disability glare in patients with dry eye. Puell et al, 2006 Aug;84(4):527-31. Click here for abstract.
American Journal of Ophthalmology
MORE OF THE SAME (PRESUMABLY). And the more repetition in this area the better, say we. The incidence and risk factors for developing dry eye after myopic LASIK. Savini et al, 2006 Aug;142(2):355-6. Abstract not available online when we went to press.
GOOPING UP THOSE LIDS: This is an interesting one: Take an ointment and apply it all along the lid margin rather than in the eye. The claim of improved symptoms is easy to believe - we've known many patients who do this regularly. We've got our concerns about ointments in general though and we'd like to see more long-term studies of what they do to ocular surface wettability. Successful tear lipid layer treatment for refractory dry eye in office workers by low-dose lipid application on the full-length eyelid margin. Goto et al, Am J Ophthalmol. 2006 Aug;142(2):264-270.e1. Click here for abstract.
DOESN'T GET MUCH SIMPLER THAN THIS : A 3-question dry eye survey is apparently accurate enough for use in epidemiological studies. Now let's get cracking on those studies! Validation and repeatability of a short questionnaire for dry eye syndrome. Gulati et al, 2006 Jul;142(1):125-131. Click here for abstract.
Archivos de la Sociedad Espanola de Oftalmologia
INFOMERCIAL BREAK for Systane... at least that's what we assume this is (haven't read the full article as we don't have a subscription). [Reduction of corneal permeability in patients treated with HP-guar: a fluorophotometric study.] Cervan-Lopez et al, 2006 Jun;81(6):327-32. Click here for abstract.
Cornea
MORE GLAUCOMA WITH DRY EYE: Ha - we thought it was the other way around, since so many people on glaucoma meds seem to get ocular surface irritation from the preservatives. This is an interesting retrospective study at the University of Cincinnati. We couldn't agree more with the last sentence in the results stating that "This information warrants increased attention to treatment and management of OSD and concurrent glaucoma." Incidence and prevalence of glaucoma in severe ocular surface disease. Tsai et al, Cornea. 2006 Jun;25(5):530-2. Click here for abstract.
AND WHAT'S GOOD ENOUGH FOR RODENTS MUST BE GOOD ENOUGH FOR US: Or at least our goblet cells. This is a study on Rebamipide completed in 2005. Rebamipide is in Phase III clinicals at present and we are hoping they will get this one approved promptly. OPC-12759 increases proliferation of cultured rat conjunctival goblet cells. Rios et al, 2006 Jun;25(5):573-81. Click here for abstract.
Current Allergy and Asthma Reports
ABOUT THAT ANTIHISTAMINE, DOC: I was very happy to see this one, as a reminder that patients need to be made aware of the potential side effects of non-ocular drugs they are taking. Can't tell you how many times I've had site visitors who had no idea their allergy or blood pressure meds might be related to their dry eye woes. Ocular toxicity of systemic asthma and allergy treatments. L Bielory, 2006 Jul;6(4):299-305. Click here for abstract.
Graefe's Archive for Clinical and Experimental Ophthalmology
EPITHELIAL CELL DENSITIES AND SUCHLIKE: This study compares corneal thickness, epithelial cell density and other corneal properties in the central and peripheral cornea of 3 groups of patients (incl. aqueous deficient and some with lagophthalmos) versus controls. In vivo confocal laser scanning microscopy of the cornea in dry eye. Erdelyi et al, 2006 Jul 28; [Epub ahead of print]. Click here for abstract.
Indoor Air
AND ALL COMPUTER USERS SAID, AMEN: Well, perhaps the cynics amongst us muttered something more like "That'll be the day." Look at this: "The workplace, thermal conditions, and work schedule (including breaks) should be planned in such a way to help maintain a normal eye blink frequency to minimize alterations of the pre-corneal tear film." Yes, yes, yes! The modern office environment desiccates the eyes? Wolkoff et al, 2006 Aug;16(4):258-65. Click here for abstract.
Infection and Immunity
MORE DETECTIVE WORK: One of the latest in efforts to understand components of the tear film and where they do and don't reside, this discusses GP340. Nothing jumped off the page at me as hugely exciting but you never know when one of these might turn into a clue to an effective new treatment. Glycoprotein 340 in normal human ocular surface tissues and tear film. Jumblatt et al, 2006 Jul;74(7):4058-63. Click here for abstract.
Investigative Ophthalmology & Visual Science
ANOTHER ONE OF THOSE: Sigh, all the right names, again, and again I'd just like to see it in words of fewer than ten syllables because this kind of science is just way over my head without some attempt at translation into English. Will somebody somewhere develop a vision for making this stuff more accessible to the rest of us? Desiccating stress stimulates expression of matrix metalloproteinases by the corneal epithelium. Corrales et al, 2006 Aug;47(8):3293-302. Click here for abstract.
HOW TO TELL GOOD TEARS FROM BAD: Especially since you can't ask the rabbits (even New Zealand Whites - and by the by, I gotta love people who are precise enough to identify the make and model of the rabbits in their abstract). But returning to the point, there seem to be some type(s) of phospholipids present only in dry eye tears. Identification and comparison of the polar phospholipids in normal and dry eye rabbit tears by maldi-tof mass spectrometry. Ham et al, 2006 Aug;47(8):3330-8. Click here for abstract.
Journal of Biomedical Materials Research (Part B, Applied Biomaterials)
HMMM - DEFINITELY ONE TO WATCH: "As a therapeutic strategy, we are working to develop a bioengineered tear secretory system...." Tissue-engineered tear secretory system: Functional lacrimal gland acinar cells cultured on matrix protein-coated substrata. Selvam et al, 2006 Jul 18; [Epub ahead of print]. Click here for abstract.
Journal of Biomedical Optics
YES, THEY REALLY ARE DIFFERENT. It's hard to get excited about an abstract establishing that the tear film in dry eyes and lens wearers differs from controls - or about a last sentence stating that artificial tears apparently help. Interferometric measurements of dynamic changes of tear film. Szczesna et al, 2006 May-Jun;11(3):34028. Click here for abstract.
Journal of Cataract & Refractive Surgery
TOO OUTRAGED TO THINK UP A CATCHY BLURB: A study in this month's JCRS challenges the FDA's listing of auto-immune diseases as a contraindication to LASIK. Valid points are made that "not all auto-immune diseases are equal", and the authors openly acknowledge the limited scope of what they are attempting (establishing incidence of severe complications only - they did NOT review any data on visual outcomes or dry eye) but even as a preliminary step towards removing this contraindication this is of great concern to us. The overall gist and this section left me foaming at the mouth: "One limitation of our study is that we do not have data on the incidence or severity of dry eye or dry-eye complaints... LASIK is associated with dry eye signs and symptoms. The high incidence and variability of dry-eye symptoms after LASIK in normal eyes and the retrospective nature of our study would have made any conclusions about dry eye unreliable." Great. Just great. Let's keep the lawyers at bay by establishing that LASIK may be just tootin' fine for many auto-immune patients, on the basis that so many people get dry eye after LASIK anyway that we really don't have a clue if having RA, lupus or Sjogrens makes it worse. Laser in situ keratomileusis in patients with autoimmune diseases, Smith et al, JCRS 2006; 32:1292-1295. Click here for abstract.
Journal Francais d'Ophtalmologie
OBOY, A NEW DIAGNOSTIC TOY! (Uh, wassup with the pet name?) The Video Tearscope ("Vi-Te") sounds like a very interesting development in non-invasive tear film diagnostics. Hope to see more on this as the research progresses. The Video Tearscope: a new method for evaluating lacrimal film in vivo, Ounnoughene et al, J Fr Ophth 2006 May;29(5):476-84. Click here for abstract.
Journal of Rheumatology
ANOTHER MARKER FOR SJOGRENS? The cumulative numbers and 'respectivelys' in the abstract are a little dizzying but there are some interesting results here in identifying activation markers of Sjogrens Syndrome. Comparative analysis of autoantibodies against a-fodrin in serum, tear fluid, and saliva from patients with Sjogren's syndrome. Yavuz et al, 2006 Jul;33(7):1289-92. Click here for abstract.
Journal of Zhejiang University (Science, B)
YA THINK? Golly, I'm sure no one ever noticed THIS before: Steroids make dry eyes feel better pretty durned fast. Maybe in a few years someone will discover a connection between steroid use and IOP - if we're really lucky. A clinical study of the efficacy of topical corticosteroids on dry eye. Yang et al, 2006 Aug;7(8):675-8. Click here for abstract.
Klinika Oczna
YADA... ON SECOND THOUGHT, NADA of value added here. [The evaluation of tears secretion after refractive surgery] Mrukwa-Kominek et al, 2006;108(1-3):73-7. Click here for abstract (translated). Article in Polish.
Ophthalmologica
I COUNTED EVERYTHING EXCEPT THE NUMBERS: Gulp. Back to the drawing board, please. How can you possibly - or rather why on earth would you bother to - attempt to gauge the cost of treating dry eye syndrome while excluding the primary forms of both treatment (artificial tear supplementation) and care (self-care and optometrists)? Worse, how could you possibly come up with a set of criteria that would determine fewer than 0.1% of the population have dry eye, even if you were trying hard to get it wrong? Worst, when you know it's wrong and are happy to admit it, why bother publishing it? The annual cost of dry eye syndrome in France, Germany, Italy, Spain, Sweden and the United kingdom among patients managed by ophthalmologists. Clegg et al, 06 Aug;13(4):263-74. Click here for abstract.
Patient-friendly highlights of recently published studies
I had to blast through this month's abstracts in a hurry but I must say I enjoyed it more than anytime in recent memory! It was relatively light on intense 16-syllable laboratory science and instead included a very welcome infusion of articles on interactions, drug side effects, environmental-related studies and epidemiology. This kind of thing is immensely helpful in raising awareness of the life-impact of dry eye - y'know, patients as people, not just pairs of crackled corneas to douse with drugs now and then.
Here are some examples of articles I enjoyed this month:
Ointment on the lid margins: A study in the American Journal of Ophthalmology studied benefits of basically lining the lid margins with ointment while at work in an attempt to counteract the problems posed for dry eyes by the office environment.
Glaucoma and dry eye: A study in Cornea looked at how many patients with dry eye (ocular surface disease) suffer from glaucoma compared with those who do not have dry eyes. This is an important area as it should encourage more attention by eye doctors to the issues posed by having to manage dry eye and glaucoma at the same time. For example, people with dry eyes may be more vulnerable to harmful effects from preservatives in glaucoma medications.
Rebamipide: The development of new dry eye drugs is excruciatingly slow, or at least seems so when you can't get enough relief from already available remedies. Those who have been following the progress of Rebamipide may be interested in this study in Cornea, which shows improvement to goblet cells, which are responsible for the mucin part of our tears and which for many of us are a key area of concern in anticipating new treatments. The peer review and publication cycle is slow - this report was submitted in early 2005 - but it will at least provide more information than has been available.
Allergy & asthma meds and dry eye: A study in Current Allergy & Asthma Reports discusses the need for increased awareness of dry eye as a side effect of systemic medications, specifically antihistamines. Bravo!!! We need more vigilance in the medical community about this - along with blood pressure medications, acne medications and many more.
"The modern office environment dessicates the eyes?" The title of this article in Indoor Air says it all! We liked this so much we wrote to congratulate the authors.
3-question dry eye survey: Although I think there are already some good dry eye surveys available that help quantify patient symptoms, which in turn helps patient-doctor communication, there is a need for something simpler that can be efficiently used for large-scale studies, and this one sounds like it may work. Now lets get on with the large-scale studies!
Study highlights
Acta Ophthalmologica Scandinavica
STARRY-EYED: The results in the abstract seem to get slightly lost amongst all the 'buts', but... I think they're saying that people with dry eyes have poorer contrast sensitivity and more disability glare than people with healthy eyes, but.... Contrast sensitivity and disability glare in patients with dry eye. Puell et al, 2006 Aug;84(4):527-31. Click here for abstract.
American Journal of Ophthalmology
MORE OF THE SAME (PRESUMABLY). And the more repetition in this area the better, say we. The incidence and risk factors for developing dry eye after myopic LASIK. Savini et al, 2006 Aug;142(2):355-6. Abstract not available online when we went to press.
GOOPING UP THOSE LIDS: This is an interesting one: Take an ointment and apply it all along the lid margin rather than in the eye. The claim of improved symptoms is easy to believe - we've known many patients who do this regularly. We've got our concerns about ointments in general though and we'd like to see more long-term studies of what they do to ocular surface wettability. Successful tear lipid layer treatment for refractory dry eye in office workers by low-dose lipid application on the full-length eyelid margin. Goto et al, Am J Ophthalmol. 2006 Aug;142(2):264-270.e1. Click here for abstract.
DOESN'T GET MUCH SIMPLER THAN THIS : A 3-question dry eye survey is apparently accurate enough for use in epidemiological studies. Now let's get cracking on those studies! Validation and repeatability of a short questionnaire for dry eye syndrome. Gulati et al, 2006 Jul;142(1):125-131. Click here for abstract.
Archivos de la Sociedad Espanola de Oftalmologia
INFOMERCIAL BREAK for Systane... at least that's what we assume this is (haven't read the full article as we don't have a subscription). [Reduction of corneal permeability in patients treated with HP-guar: a fluorophotometric study.] Cervan-Lopez et al, 2006 Jun;81(6):327-32. Click here for abstract.
Cornea
MORE GLAUCOMA WITH DRY EYE: Ha - we thought it was the other way around, since so many people on glaucoma meds seem to get ocular surface irritation from the preservatives. This is an interesting retrospective study at the University of Cincinnati. We couldn't agree more with the last sentence in the results stating that "This information warrants increased attention to treatment and management of OSD and concurrent glaucoma." Incidence and prevalence of glaucoma in severe ocular surface disease. Tsai et al, Cornea. 2006 Jun;25(5):530-2. Click here for abstract.
AND WHAT'S GOOD ENOUGH FOR RODENTS MUST BE GOOD ENOUGH FOR US: Or at least our goblet cells. This is a study on Rebamipide completed in 2005. Rebamipide is in Phase III clinicals at present and we are hoping they will get this one approved promptly. OPC-12759 increases proliferation of cultured rat conjunctival goblet cells. Rios et al, 2006 Jun;25(5):573-81. Click here for abstract.
Current Allergy and Asthma Reports
ABOUT THAT ANTIHISTAMINE, DOC: I was very happy to see this one, as a reminder that patients need to be made aware of the potential side effects of non-ocular drugs they are taking. Can't tell you how many times I've had site visitors who had no idea their allergy or blood pressure meds might be related to their dry eye woes. Ocular toxicity of systemic asthma and allergy treatments. L Bielory, 2006 Jul;6(4):299-305. Click here for abstract.
Graefe's Archive for Clinical and Experimental Ophthalmology
EPITHELIAL CELL DENSITIES AND SUCHLIKE: This study compares corneal thickness, epithelial cell density and other corneal properties in the central and peripheral cornea of 3 groups of patients (incl. aqueous deficient and some with lagophthalmos) versus controls. In vivo confocal laser scanning microscopy of the cornea in dry eye. Erdelyi et al, 2006 Jul 28; [Epub ahead of print]. Click here for abstract.
Indoor Air
AND ALL COMPUTER USERS SAID, AMEN: Well, perhaps the cynics amongst us muttered something more like "That'll be the day." Look at this: "The workplace, thermal conditions, and work schedule (including breaks) should be planned in such a way to help maintain a normal eye blink frequency to minimize alterations of the pre-corneal tear film." Yes, yes, yes! The modern office environment desiccates the eyes? Wolkoff et al, 2006 Aug;16(4):258-65. Click here for abstract.
Infection and Immunity
MORE DETECTIVE WORK: One of the latest in efforts to understand components of the tear film and where they do and don't reside, this discusses GP340. Nothing jumped off the page at me as hugely exciting but you never know when one of these might turn into a clue to an effective new treatment. Glycoprotein 340 in normal human ocular surface tissues and tear film. Jumblatt et al, 2006 Jul;74(7):4058-63. Click here for abstract.
Investigative Ophthalmology & Visual Science
ANOTHER ONE OF THOSE: Sigh, all the right names, again, and again I'd just like to see it in words of fewer than ten syllables because this kind of science is just way over my head without some attempt at translation into English. Will somebody somewhere develop a vision for making this stuff more accessible to the rest of us? Desiccating stress stimulates expression of matrix metalloproteinases by the corneal epithelium. Corrales et al, 2006 Aug;47(8):3293-302. Click here for abstract.
HOW TO TELL GOOD TEARS FROM BAD: Especially since you can't ask the rabbits (even New Zealand Whites - and by the by, I gotta love people who are precise enough to identify the make and model of the rabbits in their abstract). But returning to the point, there seem to be some type(s) of phospholipids present only in dry eye tears. Identification and comparison of the polar phospholipids in normal and dry eye rabbit tears by maldi-tof mass spectrometry. Ham et al, 2006 Aug;47(8):3330-8. Click here for abstract.
Journal of Biomedical Materials Research (Part B, Applied Biomaterials)
HMMM - DEFINITELY ONE TO WATCH: "As a therapeutic strategy, we are working to develop a bioengineered tear secretory system...." Tissue-engineered tear secretory system: Functional lacrimal gland acinar cells cultured on matrix protein-coated substrata. Selvam et al, 2006 Jul 18; [Epub ahead of print]. Click here for abstract.
Journal of Biomedical Optics
YES, THEY REALLY ARE DIFFERENT. It's hard to get excited about an abstract establishing that the tear film in dry eyes and lens wearers differs from controls - or about a last sentence stating that artificial tears apparently help. Interferometric measurements of dynamic changes of tear film. Szczesna et al, 2006 May-Jun;11(3):34028. Click here for abstract.
Journal of Cataract & Refractive Surgery
TOO OUTRAGED TO THINK UP A CATCHY BLURB: A study in this month's JCRS challenges the FDA's listing of auto-immune diseases as a contraindication to LASIK. Valid points are made that "not all auto-immune diseases are equal", and the authors openly acknowledge the limited scope of what they are attempting (establishing incidence of severe complications only - they did NOT review any data on visual outcomes or dry eye) but even as a preliminary step towards removing this contraindication this is of great concern to us. The overall gist and this section left me foaming at the mouth: "One limitation of our study is that we do not have data on the incidence or severity of dry eye or dry-eye complaints... LASIK is associated with dry eye signs and symptoms. The high incidence and variability of dry-eye symptoms after LASIK in normal eyes and the retrospective nature of our study would have made any conclusions about dry eye unreliable." Great. Just great. Let's keep the lawyers at bay by establishing that LASIK may be just tootin' fine for many auto-immune patients, on the basis that so many people get dry eye after LASIK anyway that we really don't have a clue if having RA, lupus or Sjogrens makes it worse. Laser in situ keratomileusis in patients with autoimmune diseases, Smith et al, JCRS 2006; 32:1292-1295. Click here for abstract.
Journal Francais d'Ophtalmologie
OBOY, A NEW DIAGNOSTIC TOY! (Uh, wassup with the pet name?) The Video Tearscope ("Vi-Te") sounds like a very interesting development in non-invasive tear film diagnostics. Hope to see more on this as the research progresses. The Video Tearscope: a new method for evaluating lacrimal film in vivo, Ounnoughene et al, J Fr Ophth 2006 May;29(5):476-84. Click here for abstract.
Journal of Rheumatology
ANOTHER MARKER FOR SJOGRENS? The cumulative numbers and 'respectivelys' in the abstract are a little dizzying but there are some interesting results here in identifying activation markers of Sjogrens Syndrome. Comparative analysis of autoantibodies against a-fodrin in serum, tear fluid, and saliva from patients with Sjogren's syndrome. Yavuz et al, 2006 Jul;33(7):1289-92. Click here for abstract.
Journal of Zhejiang University (Science, B)
YA THINK? Golly, I'm sure no one ever noticed THIS before: Steroids make dry eyes feel better pretty durned fast. Maybe in a few years someone will discover a connection between steroid use and IOP - if we're really lucky. A clinical study of the efficacy of topical corticosteroids on dry eye. Yang et al, 2006 Aug;7(8):675-8. Click here for abstract.
Klinika Oczna
YADA... ON SECOND THOUGHT, NADA of value added here. [The evaluation of tears secretion after refractive surgery] Mrukwa-Kominek et al, 2006;108(1-3):73-7. Click here for abstract (translated). Article in Polish.
Ophthalmologica
I COUNTED EVERYTHING EXCEPT THE NUMBERS: Gulp. Back to the drawing board, please. How can you possibly - or rather why on earth would you bother to - attempt to gauge the cost of treating dry eye syndrome while excluding the primary forms of both treatment (artificial tear supplementation) and care (self-care and optometrists)? Worse, how could you possibly come up with a set of criteria that would determine fewer than 0.1% of the population have dry eye, even if you were trying hard to get it wrong? Worst, when you know it's wrong and are happy to admit it, why bother publishing it? The annual cost of dry eye syndrome in France, Germany, Italy, Spain, Sweden and the United kingdom among patients managed by ophthalmologists. Clegg et al, 06 Aug;13(4):263-74. Click here for abstract.
Sunday, August 20, 2006
My experience with Boston Sclerals - The first six weeks
As some of you already know, in late June I went to the Boston Foundation for Sight to be fitted with scleral lenses. This is a summary of my experience to date, which I am sharing both for the benefit of patients who may be interested in this kind of treatment, and for the benefit of physicians who may be interested in hearing about the efficacy and the practical details of this particular application of sclerals. If you have any questions, please don't hesitate to ask. You can always email me privately but for efficiency's sake I prefer that questions be posted in our Sclerals forum on Dry Eye Talk so that others can read the answers too.
Background
What are sclerals? Scleral lenses are basically overgrown gas permeable lenses that restore vision and protect the surface of the eye by holding a constant fluid reservoir against the eye. They were originally designed for keratoconus patients. In recent years they have increasingly been used for patients with other types of advanced corneal disease or injuries, such as Stevens Johnson Syndrome. Most recently, there have been attempts to expand their application to cases with potential for substantial but less dramatic benefits, such as patients with partially disabling photophobia, dry eye or refractive surgery complications who have not been helped with any other treatment modality.
Why did I try sclerals and what am I hoping to achieve? In a nutshell, I am just trying to achieve a sustainable solution for my vision problems. Sclerals seemed like the safest and best way to resolve my vision problems without compromising my ocular surface, and with the side benefit of actively helping my dry eyes.
Long version... I do not have any of the obvious indications for sclerals. However, I do have two problems, both dating to my LASIK surgery back in 2001:
Poor vision: about 20/70 BCVA (meaning best vision achievable with glasses), plus multiple images, grossly reduced contrast sensitivity, and some other special effects, resulting primarily from central "islands" somehow induced by the surgery.
Dry eyes: Not bone-dry like someone with Sjögrens - I don't have much aqueous deficiency, but I exhibit the symptoms of dry eye - pain, stinging, burning, epiphora, photophobia, and so on. I suffer in some degree or another from MGD, slight lagophthalmos, and - I suspect - a mucin layer not working very well.
For me, the vision problem has always been uppermost, but the dry eye problem has been an important hindrance to getting any solution for the vision. My vision can only be corrected with some kind of gas permeable lens, and while fitting my eyes with a gas perm is challenging enough on its own that I have had to work long-distance with a specialist for years, the dryness makes it even more of a challenge.
After two years of fitful, aborted attempts at getting an RGP resolution that would allow me to drive and work regular hours, in early 2004 I finally got into a pair of specially designed Macrolenses that gave me functional vision and that I could wear for enough hours to make them valuable. This is thanks to Greg Gemoules OD, an optometrist near Dallas who has made a specialty of therapeutic lens fitting for people with complications from refractive surgeries such as RK and LASIK. I have continued to wear these lenses pretty successfully for two and a half years.
Meantime, to keep my eye surfaces in good enough shape to tolerate the lenses and to keep them in decent comfort, I have had to use several tools, including: Dwelle, Dakrina or NutraTear eyedrops as needed; occasional saline rinses (Unisol); lid hygiene (no baby shampoo for me... just lid wipes with Unisol); heat treatment for MGD (rice bag); Panoptx wraparound eyewear for daytime supplemented by Wiley-X for driving; TranquilEyes hydrating goggle at night; and fish or flaxseed oil supplements. I have seen consistent benefits from each of these over time, enough to motivate me to continue, though my need of each individually has its ups and downs.
Fast-forward to February 2006. I had invited the Boston Foundation for Sight to send a speaker to our first annual dry eye conference in Safety Harbor, Florida. Their executive director Mark Cohen kindly joined us and spent quite a bit of time answering the myriad questions from patients during the weekend. Since then I've been getting more familiar with the work they've been doing and the types of patients they've been helping and eventually concluded it might be worth trying for myself.
While I've considered myself a successful Macrolens wearer in terms of the vision and comfort they give me while the lenses were in, I experience a lot of pain after removal and anytime not wearing them. I also worry about my tolerance for Macros long-term. It just seems like having something resting, even if only slightly, on my fragile corneas cannot be a good thing. And my needs in terms of wearing time are pretty rigorous, something I could not achieve with Macros without vision declining and comfort declining noticeably towards the end of the day. The idea of having my corneas bathed in fluid all day long was hugely attractively to me IF that could be combined with vision good enough for driving standards, e.g. 20/40.
For me, trying Sclerals was not an exercise in trying to achieve perfection - just trying to achieve functional vision on a sustainable basis, and if I could get some dry eye relief thrown in as well, that's pretty compelling for me.
The fitting process
How long did it take? Short answer, three days, but please don't expect it to be that short for you/your patients!
I have to take my hat off to Mark Cohen, Dr. Rosenthal, Dr. Johns and the rest of the team at BFS stems because I asked them to accomplish a near-impossible task in terms of timing:
Patients who travel to BFS for a fitting are required to be available for 10 days, because the time required to achieve a good fit that meets their high standards, though variable, can be considerable. I only had 3 days available. I know it was unreasonable, but my particular collection of family & business responsibilities made it impossible to spend longer. The amazing thing is that they achieved so much more than I expected or imagined in that time, and were cheerfully philosophical about the strain that must have put on resources at the time.
What was involved? Briefly, the visit revolved around a series of appointments with Dr. Rosenthal and Dr. Johns, plus training sessions with a technician on insertion, removal and care of the lenses.
We started with a very thorough history, examination, refraction, discussion, topographies, and so on. Then we moved on to the fitting process itself, which works in a cycle: Put in a trial lens, examine, try it for longer, re-examine, make a lens, try it out, examine, try it longer, re-examine, repeat all these till the best fit is achieved. This process starts in an exam room with an enormous 'library' of trial lenses. The process of selecting appropriate lenses is heavily reliant on the skills of the doctors. We start with a trial lens they think may be suitable; put them in; then test the vision and examine the fit. When we get something that looks promising (that does not take long), I hang out somewhere else in the clinic for awhile so that they can look at how the lenses look after wearing them for awhile. It's been a while now and I'm a bit hazy on the details of how quickly we went to production on a new lens after wearing a trial.
When we've got a winner, we have a lens made. Each lens at BFS is individually lathed for the patient to the specifications determined by the doctor. In my case, because of my dry eyes, the lenses also had to be plasma-treated. Given that we went from 0 to 100 in just three days, and made - I don't remember now but I think at least 3 lenses for each eyes, you can imagine how rapidly this process moved along and how much was done.
Somewhere during lens iterations, there was an interesting minor equipment failure that I found educational.... A lens that was supposed to be plasma-treated did not appear to be treated. This was immediately apparent on inserting the lens, because it didn't "wet" properly. Most of the other lenses I'd tried had excellent wetting but this one seemed to fog over immediately. I had not realized before what a difference something like that could make. When the same lens was finally treated, it performed fine.
I had to cut the whole thing short prematurely because of time constraints. When I left the Foundation on Wednesday, I was supposed to come back in the morning. I tried to get my flight changed to allow me to do so, however, it was on a bad travel day and due to flight cancellations everything was booked up solid with long standby lists, so I did not make it back in. My last pair of lenses, I just kind of took it on faith that they would work out. Thank God they did.
And the training process? This part was almost certainly different for me than it would have been for the vast majority of patients because of my background. Having worn Macrolenses for years, putting a big gas perm in my eye and using a "plunger" to remove it was no big deal, and with the exception of hydrogen peroxide to soak the lenses, I was already using the same lens care products. The only really new thing to me was the special device used to insert the lenses, and I had to practice the insertion technique a bit as the lenses really are quite a bit bigger than Macros. I would expect though, from what I heard and observed, that most patients would spend a lot more time in training than I did, thoroughly familiarizing themselves with everything and getting more comfortable with the process. The technician was excellent, very patient and detail-oriented.
What's the place like? The Foundation is a fascinating place to me. It's got all the warmth and caring of a family, and patients are really pampered and cared for. But the collective brainpower and experience within those walls is awesome, from the lab where the lenses are made on six-figure equipment right up to the doctors fitting the lenses. It's all state-of-the-art. What I most appreciated about it though is the doctor time lavished on patients. One of the complaints I hear most frequently on Dry Eye Talk from patients is, "I waited all that time/flew to XXX city/etc etc and the doctor just rushed me through in about 5 minutes". There are plenty of exceptions to that - hidden gems here and there, doctors that can manage to put patients needs over profits and paperwork. It's really inspiring to see an entire medical facility run on the principle of doing the best job possible for the patient.
Adaptation period
I would expect that in some ways the adjustment must have been simpler and shorter for me than for a lot of other patients, because of my background. If you'd never worn contact lenses at all, or had only worn standard-size RGPs or soft lenses, the strangeness factor could conceivably be considerable. Just the insertion and removal process would be so new that it would take a little while to get used to it. And there's the visuals. I work around eyeballs, and pictures or videos of gory-looking eye diseases don't faze me, but I can imagine that for "normal" people, seeing your eyeball squeezed into a slightly different shape (temorarily) after removing a lens might be unnerving, even if you know it's harmless. It only happened to me a couple of times, but I remember saying to myself, "If I were the type to get grossed out easily, I'd be feeling kind of funny right now." - The only problem I did run into was with some initial dizziness & headaches. As far as I've been able to find out, that's not happened to anyone else, so I haven't really pinned down why it happened to me, and after a few days it subsided, but initially it slowed me down.
I can't really think of any other aspect that might be a struggle for a new user, but I wouldn't be surprised to hear there are some, especially from those who have never before worn contact lenses. Different perspectives, different experiences. The staff at BFS do so much though to prepare you that I think if patients spend the proper amount of time there (I didn't) they'd get past most of that before even returning home.
Results
Vision (daytime): In the context of my vision history, the results are outstanding. Truthfully, assuming 6 weeks to be a decent trial period, I have not seen this well this consistently in five years. My dominant right eye which has always been very troublesome now gives me terrific vision - probably 20/25 or 20/30, and very clean, unaberrated - and, most importantly, it stays stable pretty much all day. If that doesn't sound impressive enough, it should, because getting my vision to a 'clean' 20/30 has always proven a difficult task on my very flat, irregular, highly aberrated corneas. My left eye is probably a little bit behind the right in terms of acuity but it's my non-dominant eye and I've found that having my right eye perform so well makes a very noticeable difference, especially while driving. I'd kind of adapted myself to having to do a lot of u-turns because I can't read signs in time, but I'm finding now I am doing a lot better with signs.
Vision (nighttime): I know plenty of LASIK patients out there are going to be curious about what the sclerals do for my night vision. For reference my spherical aberrations are way off the chart. (I was about -12.00 prior to LASIK and had smaller than a 6mm programmed optical zone on a 7.5mm dark-adapted pupil.) With my Macros, since DrG was far away I'd simply never been able to invest the time to give him an opportunity to optimize the lenses for night vision. My main goal was and is just functional daytime vision, so once I've got something that works I just cut & run. The Macros improved my contrast greatly but did not relieve starbursting, haloes etc. much. Now, with sclerals, to be honest I am so much out of the habit of venturing out at night that I don't have a lot to report yet. I will report back more when I've put more effort into it. (And like with my Macros, this wasn't my goal - and again there was no time to focus on it.)
So far, I have noticed small starbursts while driving at dusk; more so in my left eye than my right. Overall from what little I've observed I think that what I can safely say is this: There appears to be a large enough reduction in overall aberrations for me that I would have no difficulty believing this MAY be a very effective way of improving night vision symptoms in patients for whom that is a primary complaint. I would be very interested to see the results of trying that out on several patients who like me had a large pupil/treatment zone gap on a moderate to high prescription. The literature has proven that higher order aberrations can be dramatically reduced with a corneal or corneal-scleral lens so logically, it stands to reason that it can be done with a scleral lens.
Comfort while wearing lenses: Excellent. I pretty much don't notice them most of the day. In the evening I start to notice them. They're never painful or bothersome, I just start having some kind of 'sensations' in the evening, enough that I'm quite ready to take them out by bedtime. I believe that if I were to remove them at least once during the day, I could get increased comfort during the evening, however, so far I just plain haven't been motivated.
What has really surprised me about the lenses is how little I need to lubricate them. I started out lubricating them with NutraTear every 3 hours or so, but it really turned out to be unnecessary. I can sometimes go as long as 12 hours without a drop of anything.
Wear time: I put them in when I wake up and I take them out just before bed. Hard to beat that.
I have to believe that "your mileage may vary", especially for those who have severe aqueous deficiency. Lens-lid lubrication has to present some real challenges for very dry patients. I think that my mileage with these lenses is far greater than I was told to expect, so I've been vastly pleased from that standpoint.
Dry eye symptoms: Now that's the wonderful part! When I take them out at night MY EYES DON'T HURT! What a concept. I can be placid about all the other aspects (or almost... I do really like being able to read my exit sign before I drive past the exit) but this one still has me amazed, every single night. I can get into bed at night and not be in pain! WOO HOOOOOOOOO! I can take lenses out and not immediately slap a washcloth over my eyes or squirt saline at them to try and stave off the pain! Yee haw.
Seriously, it's really something. I think that it is still early to draw any conclusions about long-term benefits, but in the short term, I can definitely point to improved overall nighttime comfort. I have even cut down on using drops and TranquilEyes at night. An interesting thing I discovered in this process was how much of the pain I had simply adapted to and tuned out. I noticed the pain more from its absence than its presence. I was thinking about that and how incredible it was to have my eyes feel so good at the end of the day and it suddenly struck me that I never really thought of my eyes as being THAT "bad" at the end of the day till... I experienced what "good" can feel like.
Another big test of what Sclerals can do (for me) was during my recent move. I drove across the country during a heat wave and was able to do 500 or more miles every day. I honestly don't think I could have done that without the sclerals. I had my 3-year-old with me, so just sweating it out wasn't an option, and I think my eyes would have been hamburger (and my vision crud) from the air conditioning.
My routine now
Lens care (in the eye): I use NutraTear to lubricate my lenses when needed during the day. NutraTear was instrumental to my success in Macrolenses and, though to a lesser extent, I think it's also important with my sclerals - feels great and keeps things going longer. (It's also the only drop I've ever been able to tolerate the feel of over a contact.) Occasionally, in the evening, I might douse them with Unisol for the feelgood factor to keep me going a little longer.
Lens care (out of the eye): I soak them in hydrogen peroxide. I clean them with Lobob Extra Strength Cleaner (wonderful stuff, always used it with my Macros as well). I rinse and insert them with Unisol. I don't know how anybody with long nails could possibly clean a lens like this - you'd probably have to have one nail short for the purpose.
Insertion/removal: Nothing special to say. I pretty much get them in fine on the first try. Removing them, the first few days I struggled a little and got a little worried. That stuck feeling... that "thwaaack" sound, ugh! But, I was trading experienced with a kind and much more experienced friend shared some tips (thanks Phillipp!!) and I found that a little bit of clockwise rotation made all the difference in the world and now they always come out immediately with no difficulty at all. Oh - and I always put a towel in the sink first. The lenses often drop into the sink while removing them and I wouldn't want to risk breaking or losing one.
Dry eye care: Right now I'm in the Pacific Northwest and so it's hard to gauge what's climate-related and what's lens-related but I'm going through a stretch where I seem to need blessedly little to keep me going. I'm not even using drops at night. Presumably the absence of air conditioning is making a fair amount of the difference. However, I was already experiencing some progressive improvement while in Florida. There, I still definitely needed wraparound eyewear outdoors (I don't seem to here as much). Sclerals by day and TranquilEyes by night seemed to make a huge difference to overnight dryness there; here I haven't bothered with the TranquilEyes - though I suspect I will need to as soon as we start having to turn the heat on. For now, I'm just enjoying the break!
Conclusions?
My first six weeks in sclerals has been thoroughly successful in terms of visual performance, lens comfort, wear time and dry eye symptoms. I do not find any aspect of lens care unduly burdensome. I'm 100% pleased with the results.
This has encouraged me to hope that it may be a good solution for some other patients like me who don't appear to fit the "classic" profile of a scleral candidate (keratoconus, Stevens Johnson Syndrome, etc) but yet who have corneal disease or injury conditions that have not been satisfactorily addressed through other means. It has also thoroughly convinced me that the people who DO fit the "classic" profile ought to consider this as their #1 treatment of choice - especially if the alternatives are surgery.
A note for the LASIK patients reading this
I would like to share a few thoughts for a group I always have close to my heart, LASIK complications patients, some of whom may be considering sclerals. (Some of this also applies to patients with severe chronic dry eye symptoms from other causes such as drug side effects.)
While my problems are exclusively LASIK related, I am not necessarily a good benchmark for post-LASIK use of sclerals. I had an uncommonly large loss of BCVA, so in one respect at least, I have a lot more to gain from lenses in terms of basic functionality than most patients, meaning that one could fairly expect I'd be more tolerant of drawbacks or perceived "hassle factors" or cost than other patients. Looking at the more typical LASIK patient such as the ones I've met on SurgicalEyes and D'Eyealogues and Dry Eye Talk over the years, the issues are usually night vision symptoms and severe dry eye symptoms. My experience has certainly made me most hopeful that such patients could find their symptoms greatly alleviated with sclerals.
However, the question of acceptable benefits and acceptable tradeoffs is intensely individual. Without meaning this in the least as a slight, I believe that taken in the mass, LASIK patients have higher expectations from treatments and lower tolerance of tradeoffs than people suffering from eye diseases they came by gradually.
I think that LASIK patients seeking help from sclerals, particularly for severe dry eye or for dry eye plus night vision problems, still have much to gain. But I think that in order to maximize their chances for success, they ought to take a number of preparatory steps before actively pursuing sclerals, including: a) learning as much as possible about the entire process (including the fitting process, lens care and so on), and b) identifying very specific goals for themselves. You can't go into something like this with the expectation of a magic bullet that will reverse the past. You have to say to yourself, "What is it I really want most? What activity would I like to be able to do again, that would make this all worthwhile? or, What are the top three things I have missed most since my surgery?" I think that putting a very well defined face on your expectations is a good recipe for success.
Acknowledgments
I owe an enormous debt of gratitude - to Mark Cohen for painstakingly educating me about BFS and sclerals and for so kindly facilitating my visit there; to Drs. Rosenthal and Johns for working so hard to get my fitting done under excessive time constraits and for doing such a brilliant job of it; and to the entire staff at BFS for their kindness and excellent work. What a terrific team. - Dr. Rosenthal has done an incredible service to the world by developing this treatment and making it available through a nonprofit foundation. Well done.
Pardon the typos... I was so late getting this done I haven't proofread yet.
Have a great month everyone.
Background
What are sclerals? Scleral lenses are basically overgrown gas permeable lenses that restore vision and protect the surface of the eye by holding a constant fluid reservoir against the eye. They were originally designed for keratoconus patients. In recent years they have increasingly been used for patients with other types of advanced corneal disease or injuries, such as Stevens Johnson Syndrome. Most recently, there have been attempts to expand their application to cases with potential for substantial but less dramatic benefits, such as patients with partially disabling photophobia, dry eye or refractive surgery complications who have not been helped with any other treatment modality.
Why did I try sclerals and what am I hoping to achieve? In a nutshell, I am just trying to achieve a sustainable solution for my vision problems. Sclerals seemed like the safest and best way to resolve my vision problems without compromising my ocular surface, and with the side benefit of actively helping my dry eyes.
Long version... I do not have any of the obvious indications for sclerals. However, I do have two problems, both dating to my LASIK surgery back in 2001:
Poor vision: about 20/70 BCVA (meaning best vision achievable with glasses), plus multiple images, grossly reduced contrast sensitivity, and some other special effects, resulting primarily from central "islands" somehow induced by the surgery.
Dry eyes: Not bone-dry like someone with Sjögrens - I don't have much aqueous deficiency, but I exhibit the symptoms of dry eye - pain, stinging, burning, epiphora, photophobia, and so on. I suffer in some degree or another from MGD, slight lagophthalmos, and - I suspect - a mucin layer not working very well.
For me, the vision problem has always been uppermost, but the dry eye problem has been an important hindrance to getting any solution for the vision. My vision can only be corrected with some kind of gas permeable lens, and while fitting my eyes with a gas perm is challenging enough on its own that I have had to work long-distance with a specialist for years, the dryness makes it even more of a challenge.
After two years of fitful, aborted attempts at getting an RGP resolution that would allow me to drive and work regular hours, in early 2004 I finally got into a pair of specially designed Macrolenses that gave me functional vision and that I could wear for enough hours to make them valuable. This is thanks to Greg Gemoules OD, an optometrist near Dallas who has made a specialty of therapeutic lens fitting for people with complications from refractive surgeries such as RK and LASIK. I have continued to wear these lenses pretty successfully for two and a half years.
Meantime, to keep my eye surfaces in good enough shape to tolerate the lenses and to keep them in decent comfort, I have had to use several tools, including: Dwelle, Dakrina or NutraTear eyedrops as needed; occasional saline rinses (Unisol); lid hygiene (no baby shampoo for me... just lid wipes with Unisol); heat treatment for MGD (rice bag); Panoptx wraparound eyewear for daytime supplemented by Wiley-X for driving; TranquilEyes hydrating goggle at night; and fish or flaxseed oil supplements. I have seen consistent benefits from each of these over time, enough to motivate me to continue, though my need of each individually has its ups and downs.
Fast-forward to February 2006. I had invited the Boston Foundation for Sight to send a speaker to our first annual dry eye conference in Safety Harbor, Florida. Their executive director Mark Cohen kindly joined us and spent quite a bit of time answering the myriad questions from patients during the weekend. Since then I've been getting more familiar with the work they've been doing and the types of patients they've been helping and eventually concluded it might be worth trying for myself.
While I've considered myself a successful Macrolens wearer in terms of the vision and comfort they give me while the lenses were in, I experience a lot of pain after removal and anytime not wearing them. I also worry about my tolerance for Macros long-term. It just seems like having something resting, even if only slightly, on my fragile corneas cannot be a good thing. And my needs in terms of wearing time are pretty rigorous, something I could not achieve with Macros without vision declining and comfort declining noticeably towards the end of the day. The idea of having my corneas bathed in fluid all day long was hugely attractively to me IF that could be combined with vision good enough for driving standards, e.g. 20/40.
For me, trying Sclerals was not an exercise in trying to achieve perfection - just trying to achieve functional vision on a sustainable basis, and if I could get some dry eye relief thrown in as well, that's pretty compelling for me.
The fitting process
How long did it take? Short answer, three days, but please don't expect it to be that short for you/your patients!
I have to take my hat off to Mark Cohen, Dr. Rosenthal, Dr. Johns and the rest of the team at BFS stems because I asked them to accomplish a near-impossible task in terms of timing:
Patients who travel to BFS for a fitting are required to be available for 10 days, because the time required to achieve a good fit that meets their high standards, though variable, can be considerable. I only had 3 days available. I know it was unreasonable, but my particular collection of family & business responsibilities made it impossible to spend longer. The amazing thing is that they achieved so much more than I expected or imagined in that time, and were cheerfully philosophical about the strain that must have put on resources at the time.
What was involved? Briefly, the visit revolved around a series of appointments with Dr. Rosenthal and Dr. Johns, plus training sessions with a technician on insertion, removal and care of the lenses.
We started with a very thorough history, examination, refraction, discussion, topographies, and so on. Then we moved on to the fitting process itself, which works in a cycle: Put in a trial lens, examine, try it for longer, re-examine, make a lens, try it out, examine, try it longer, re-examine, repeat all these till the best fit is achieved. This process starts in an exam room with an enormous 'library' of trial lenses. The process of selecting appropriate lenses is heavily reliant on the skills of the doctors. We start with a trial lens they think may be suitable; put them in; then test the vision and examine the fit. When we get something that looks promising (that does not take long), I hang out somewhere else in the clinic for awhile so that they can look at how the lenses look after wearing them for awhile. It's been a while now and I'm a bit hazy on the details of how quickly we went to production on a new lens after wearing a trial.
When we've got a winner, we have a lens made. Each lens at BFS is individually lathed for the patient to the specifications determined by the doctor. In my case, because of my dry eyes, the lenses also had to be plasma-treated. Given that we went from 0 to 100 in just three days, and made - I don't remember now but I think at least 3 lenses for each eyes, you can imagine how rapidly this process moved along and how much was done.
Somewhere during lens iterations, there was an interesting minor equipment failure that I found educational.... A lens that was supposed to be plasma-treated did not appear to be treated. This was immediately apparent on inserting the lens, because it didn't "wet" properly. Most of the other lenses I'd tried had excellent wetting but this one seemed to fog over immediately. I had not realized before what a difference something like that could make. When the same lens was finally treated, it performed fine.
I had to cut the whole thing short prematurely because of time constraints. When I left the Foundation on Wednesday, I was supposed to come back in the morning. I tried to get my flight changed to allow me to do so, however, it was on a bad travel day and due to flight cancellations everything was booked up solid with long standby lists, so I did not make it back in. My last pair of lenses, I just kind of took it on faith that they would work out. Thank God they did.
And the training process? This part was almost certainly different for me than it would have been for the vast majority of patients because of my background. Having worn Macrolenses for years, putting a big gas perm in my eye and using a "plunger" to remove it was no big deal, and with the exception of hydrogen peroxide to soak the lenses, I was already using the same lens care products. The only really new thing to me was the special device used to insert the lenses, and I had to practice the insertion technique a bit as the lenses really are quite a bit bigger than Macros. I would expect though, from what I heard and observed, that most patients would spend a lot more time in training than I did, thoroughly familiarizing themselves with everything and getting more comfortable with the process. The technician was excellent, very patient and detail-oriented.
What's the place like? The Foundation is a fascinating place to me. It's got all the warmth and caring of a family, and patients are really pampered and cared for. But the collective brainpower and experience within those walls is awesome, from the lab where the lenses are made on six-figure equipment right up to the doctors fitting the lenses. It's all state-of-the-art. What I most appreciated about it though is the doctor time lavished on patients. One of the complaints I hear most frequently on Dry Eye Talk from patients is, "I waited all that time/flew to XXX city/etc etc and the doctor just rushed me through in about 5 minutes". There are plenty of exceptions to that - hidden gems here and there, doctors that can manage to put patients needs over profits and paperwork. It's really inspiring to see an entire medical facility run on the principle of doing the best job possible for the patient.
Adaptation period
I would expect that in some ways the adjustment must have been simpler and shorter for me than for a lot of other patients, because of my background. If you'd never worn contact lenses at all, or had only worn standard-size RGPs or soft lenses, the strangeness factor could conceivably be considerable. Just the insertion and removal process would be so new that it would take a little while to get used to it. And there's the visuals. I work around eyeballs, and pictures or videos of gory-looking eye diseases don't faze me, but I can imagine that for "normal" people, seeing your eyeball squeezed into a slightly different shape (temorarily) after removing a lens might be unnerving, even if you know it's harmless. It only happened to me a couple of times, but I remember saying to myself, "If I were the type to get grossed out easily, I'd be feeling kind of funny right now." - The only problem I did run into was with some initial dizziness & headaches. As far as I've been able to find out, that's not happened to anyone else, so I haven't really pinned down why it happened to me, and after a few days it subsided, but initially it slowed me down.
I can't really think of any other aspect that might be a struggle for a new user, but I wouldn't be surprised to hear there are some, especially from those who have never before worn contact lenses. Different perspectives, different experiences. The staff at BFS do so much though to prepare you that I think if patients spend the proper amount of time there (I didn't) they'd get past most of that before even returning home.
Results
Vision (daytime): In the context of my vision history, the results are outstanding. Truthfully, assuming 6 weeks to be a decent trial period, I have not seen this well this consistently in five years. My dominant right eye which has always been very troublesome now gives me terrific vision - probably 20/25 or 20/30, and very clean, unaberrated - and, most importantly, it stays stable pretty much all day. If that doesn't sound impressive enough, it should, because getting my vision to a 'clean' 20/30 has always proven a difficult task on my very flat, irregular, highly aberrated corneas. My left eye is probably a little bit behind the right in terms of acuity but it's my non-dominant eye and I've found that having my right eye perform so well makes a very noticeable difference, especially while driving. I'd kind of adapted myself to having to do a lot of u-turns because I can't read signs in time, but I'm finding now I am doing a lot better with signs.
Vision (nighttime): I know plenty of LASIK patients out there are going to be curious about what the sclerals do for my night vision. For reference my spherical aberrations are way off the chart. (I was about -12.00 prior to LASIK and had smaller than a 6mm programmed optical zone on a 7.5mm dark-adapted pupil.) With my Macros, since DrG was far away I'd simply never been able to invest the time to give him an opportunity to optimize the lenses for night vision. My main goal was and is just functional daytime vision, so once I've got something that works I just cut & run. The Macros improved my contrast greatly but did not relieve starbursting, haloes etc. much. Now, with sclerals, to be honest I am so much out of the habit of venturing out at night that I don't have a lot to report yet. I will report back more when I've put more effort into it. (And like with my Macros, this wasn't my goal - and again there was no time to focus on it.)
So far, I have noticed small starbursts while driving at dusk; more so in my left eye than my right. Overall from what little I've observed I think that what I can safely say is this: There appears to be a large enough reduction in overall aberrations for me that I would have no difficulty believing this MAY be a very effective way of improving night vision symptoms in patients for whom that is a primary complaint. I would be very interested to see the results of trying that out on several patients who like me had a large pupil/treatment zone gap on a moderate to high prescription. The literature has proven that higher order aberrations can be dramatically reduced with a corneal or corneal-scleral lens so logically, it stands to reason that it can be done with a scleral lens.
Comfort while wearing lenses: Excellent. I pretty much don't notice them most of the day. In the evening I start to notice them. They're never painful or bothersome, I just start having some kind of 'sensations' in the evening, enough that I'm quite ready to take them out by bedtime. I believe that if I were to remove them at least once during the day, I could get increased comfort during the evening, however, so far I just plain haven't been motivated.
What has really surprised me about the lenses is how little I need to lubricate them. I started out lubricating them with NutraTear every 3 hours or so, but it really turned out to be unnecessary. I can sometimes go as long as 12 hours without a drop of anything.
Wear time: I put them in when I wake up and I take them out just before bed. Hard to beat that.
I have to believe that "your mileage may vary", especially for those who have severe aqueous deficiency. Lens-lid lubrication has to present some real challenges for very dry patients. I think that my mileage with these lenses is far greater than I was told to expect, so I've been vastly pleased from that standpoint.
Dry eye symptoms: Now that's the wonderful part! When I take them out at night MY EYES DON'T HURT! What a concept. I can be placid about all the other aspects (or almost... I do really like being able to read my exit sign before I drive past the exit) but this one still has me amazed, every single night. I can get into bed at night and not be in pain! WOO HOOOOOOOOO! I can take lenses out and not immediately slap a washcloth over my eyes or squirt saline at them to try and stave off the pain! Yee haw.
Seriously, it's really something. I think that it is still early to draw any conclusions about long-term benefits, but in the short term, I can definitely point to improved overall nighttime comfort. I have even cut down on using drops and TranquilEyes at night. An interesting thing I discovered in this process was how much of the pain I had simply adapted to and tuned out. I noticed the pain more from its absence than its presence. I was thinking about that and how incredible it was to have my eyes feel so good at the end of the day and it suddenly struck me that I never really thought of my eyes as being THAT "bad" at the end of the day till... I experienced what "good" can feel like.
Another big test of what Sclerals can do (for me) was during my recent move. I drove across the country during a heat wave and was able to do 500 or more miles every day. I honestly don't think I could have done that without the sclerals. I had my 3-year-old with me, so just sweating it out wasn't an option, and I think my eyes would have been hamburger (and my vision crud) from the air conditioning.
My routine now
Lens care (in the eye): I use NutraTear to lubricate my lenses when needed during the day. NutraTear was instrumental to my success in Macrolenses and, though to a lesser extent, I think it's also important with my sclerals - feels great and keeps things going longer. (It's also the only drop I've ever been able to tolerate the feel of over a contact.) Occasionally, in the evening, I might douse them with Unisol for the feelgood factor to keep me going a little longer.
Lens care (out of the eye): I soak them in hydrogen peroxide. I clean them with Lobob Extra Strength Cleaner (wonderful stuff, always used it with my Macros as well). I rinse and insert them with Unisol. I don't know how anybody with long nails could possibly clean a lens like this - you'd probably have to have one nail short for the purpose.
Insertion/removal: Nothing special to say. I pretty much get them in fine on the first try. Removing them, the first few days I struggled a little and got a little worried. That stuck feeling... that "thwaaack" sound, ugh! But, I was trading experienced with a kind and much more experienced friend shared some tips (thanks Phillipp!!) and I found that a little bit of clockwise rotation made all the difference in the world and now they always come out immediately with no difficulty at all. Oh - and I always put a towel in the sink first. The lenses often drop into the sink while removing them and I wouldn't want to risk breaking or losing one.
Dry eye care: Right now I'm in the Pacific Northwest and so it's hard to gauge what's climate-related and what's lens-related but I'm going through a stretch where I seem to need blessedly little to keep me going. I'm not even using drops at night. Presumably the absence of air conditioning is making a fair amount of the difference. However, I was already experiencing some progressive improvement while in Florida. There, I still definitely needed wraparound eyewear outdoors (I don't seem to here as much). Sclerals by day and TranquilEyes by night seemed to make a huge difference to overnight dryness there; here I haven't bothered with the TranquilEyes - though I suspect I will need to as soon as we start having to turn the heat on. For now, I'm just enjoying the break!
Conclusions?
My first six weeks in sclerals has been thoroughly successful in terms of visual performance, lens comfort, wear time and dry eye symptoms. I do not find any aspect of lens care unduly burdensome. I'm 100% pleased with the results.
This has encouraged me to hope that it may be a good solution for some other patients like me who don't appear to fit the "classic" profile of a scleral candidate (keratoconus, Stevens Johnson Syndrome, etc) but yet who have corneal disease or injury conditions that have not been satisfactorily addressed through other means. It has also thoroughly convinced me that the people who DO fit the "classic" profile ought to consider this as their #1 treatment of choice - especially if the alternatives are surgery.
A note for the LASIK patients reading this
I would like to share a few thoughts for a group I always have close to my heart, LASIK complications patients, some of whom may be considering sclerals. (Some of this also applies to patients with severe chronic dry eye symptoms from other causes such as drug side effects.)
While my problems are exclusively LASIK related, I am not necessarily a good benchmark for post-LASIK use of sclerals. I had an uncommonly large loss of BCVA, so in one respect at least, I have a lot more to gain from lenses in terms of basic functionality than most patients, meaning that one could fairly expect I'd be more tolerant of drawbacks or perceived "hassle factors" or cost than other patients. Looking at the more typical LASIK patient such as the ones I've met on SurgicalEyes and D'Eyealogues and Dry Eye Talk over the years, the issues are usually night vision symptoms and severe dry eye symptoms. My experience has certainly made me most hopeful that such patients could find their symptoms greatly alleviated with sclerals.
However, the question of acceptable benefits and acceptable tradeoffs is intensely individual. Without meaning this in the least as a slight, I believe that taken in the mass, LASIK patients have higher expectations from treatments and lower tolerance of tradeoffs than people suffering from eye diseases they came by gradually.
I think that LASIK patients seeking help from sclerals, particularly for severe dry eye or for dry eye plus night vision problems, still have much to gain. But I think that in order to maximize their chances for success, they ought to take a number of preparatory steps before actively pursuing sclerals, including: a) learning as much as possible about the entire process (including the fitting process, lens care and so on), and b) identifying very specific goals for themselves. You can't go into something like this with the expectation of a magic bullet that will reverse the past. You have to say to yourself, "What is it I really want most? What activity would I like to be able to do again, that would make this all worthwhile? or, What are the top three things I have missed most since my surgery?" I think that putting a very well defined face on your expectations is a good recipe for success.
Acknowledgments
I owe an enormous debt of gratitude - to Mark Cohen for painstakingly educating me about BFS and sclerals and for so kindly facilitating my visit there; to Drs. Rosenthal and Johns for working so hard to get my fitting done under excessive time constraits and for doing such a brilliant job of it; and to the entire staff at BFS for their kindness and excellent work. What a terrific team. - Dr. Rosenthal has done an incredible service to the world by developing this treatment and making it available through a nonprofit foundation. Well done.
Pardon the typos... I was so late getting this done I haven't proofread yet.
Have a great month everyone.
Wednesday, August 16, 2006
Dry eyes, corner to corner
I thought I was already well aware of the role of climate in dry eye, but I have to admit I gained a powerful new appreciation for it on a recent long drive I took. Long as in days, not hours. I drove from Florida to Washington state, where we had decided to move in order to be closer to our extended family.
We sprinted through northern Florida, Georgia, Tennessee, Kentucky, I think a little bit of Iowa if I remember right, southern Illinois, and Missouri - all during that awful 100+ degree heatwave so we had no motivation to do any sightseeing along the way. We finally slowed down in Nebraska, stopped to visit a friend, took a detour up a back road through the sand hills (stunningly beautiful, though we didn't get as far as we wanted due to some wildfires), took a scenic loop through the Badlands of South Dakota, and introduced my 3-year-old to Mount 'Mushmore' and the largest collection of reptiles in the world at the Reptile Gardens nearby. Running short on time, we then got back on the interstate and sped across Wyoming, Montana, the Idaho panhandle and eastern Washington.
I think it was in Tennessee that I broke my Wiley-X wraparound sunglasses. They have always been my favorites for driving - wraparound style and light foam pads give some protection from the air conditioning but with good quality vision - and I hadn't brought any spares, so I drove the rest of the trip with a $10 pair of sunglasses that didn't do a thing. That was a great test of my new sclerals - more on that shortly.
When we stopped in Nebraska, though, I could hardly stand to get out of the car. Between the heat and the wind it was awful. I just can't imagine living there with dry eye - of course not all days are that bad but outdoors activities would be a thing of the past.
On the other hand, since arriving in the Pacific Northwest, what a difference! I don't think my eyes have been this comfortable outside in an awfully long time.
We sprinted through northern Florida, Georgia, Tennessee, Kentucky, I think a little bit of Iowa if I remember right, southern Illinois, and Missouri - all during that awful 100+ degree heatwave so we had no motivation to do any sightseeing along the way. We finally slowed down in Nebraska, stopped to visit a friend, took a detour up a back road through the sand hills (stunningly beautiful, though we didn't get as far as we wanted due to some wildfires), took a scenic loop through the Badlands of South Dakota, and introduced my 3-year-old to Mount 'Mushmore' and the largest collection of reptiles in the world at the Reptile Gardens nearby. Running short on time, we then got back on the interstate and sped across Wyoming, Montana, the Idaho panhandle and eastern Washington.
I think it was in Tennessee that I broke my Wiley-X wraparound sunglasses. They have always been my favorites for driving - wraparound style and light foam pads give some protection from the air conditioning but with good quality vision - and I hadn't brought any spares, so I drove the rest of the trip with a $10 pair of sunglasses that didn't do a thing. That was a great test of my new sclerals - more on that shortly.
When we stopped in Nebraska, though, I could hardly stand to get out of the car. Between the heat and the wind it was awful. I just can't imagine living there with dry eye - of course not all days are that bad but outdoors activities would be a thing of the past.
On the other hand, since arriving in the Pacific Northwest, what a difference! I don't think my eyes have been this comfortable outside in an awfully long time.
Tuesday, August 15, 2006
Newsclips (July-August)
Dry Eye in the News
7 August: Health tip: If your eyes are dry
Forbes. Three brief paragraphs of common sense. But we like that they mentioned cold and allergy medications as a dry eye culprit!
7 August: Ask DrH... Long use of drops safe for dry eyes?
Philadelphia Inquirer. Patient asks about long-term safety of Restasis. Answer buried in the 6 paragraphs of educational blah blah is that it 'appears safe for long-term use'.
2 August: How to relieve dry eye syndrome naturally
Emax Health: This is actually a really nice basic educational piece about dry eye causes that includes a solid list of non-drug practical steps for managing chronic dry eye. Thumbs up.
25 July: Dry eye dangers are often missed
USA Today. Humph. I wonder if the journalist was aware that dry eye is the #1 side effect of LASIK when they went and got a quote from a prominent laser surgeon. And the NWHRC gets their little plug in for Restasis... again. Pass.
25 July: Symptoms, causes, treatments for dry eye
The Arizona Republic: "Here's information to help you prevent, identify and treat the problem of dry eye...." Thoroughly respectable article.
23 July: Menopause can cause dry eye syndrome
10 News: "...Dry eye syndrome is a common condition endured by menopausal and peri-menopausal women...." Decent read.
20 July: Can-Fite Initiated Phase IIb Clinical Trials in Rheumatoid Arthritis Patients... blah blah
Genengnews.com: "the Company will shortly begin evaluating the efficacy of this drug in the treatment of dry eye syndrome..." I love the word "shortly". Fine, keep saying it, but we sure hope you actually DO it soon.
19 July: International Group Targets Sjögrens Syndrome
UCSF Today: The Sjögren's International Collaborative Clinical Alliance (SICCA) met in DC recently.... This is a group of clinical and laboratory investigators focusing on the development of the International Sjögren's Syndrome Registry. Don't know much about this organization but it's good to have one out there promoting research on prevention & treatments.
17 July: Alimera Sciences Announces Agreement with CYNACON / OCuSOFT(R), to Co-Promote OCuSOFT(R) Lid Scrub Eyelid Cleanser
PRNewsWire: Whole story in the title. This is probably a good thing as it will increase awareness of the importance of lid hygiene. Presumably prompted in part by the launch of TheraTears Sterilid product.
12 July: Sinclair Pharma: Opthalmology Product Gets Regulatory OK
Sinclair press release page: New product released in the UK as a medical device class I (sterile). From the limited information in the press release it is not clear whether this really presents some truly new or improved kind of mechanism or is basically a souped up artificial tear marketed as a prescription drug. Waiting on more info from Sinclair about active ingredients and preservatives.
1 July: New study puts the focus on dry eye
The Salt Lake Tribune: Bragging about being the seventh worst city for dry eye. Good article overall.
7 August: Health tip: If your eyes are dry
Forbes. Three brief paragraphs of common sense. But we like that they mentioned cold and allergy medications as a dry eye culprit!
7 August: Ask DrH... Long use of drops safe for dry eyes?
Philadelphia Inquirer. Patient asks about long-term safety of Restasis. Answer buried in the 6 paragraphs of educational blah blah is that it 'appears safe for long-term use'.
2 August: How to relieve dry eye syndrome naturally
Emax Health: This is actually a really nice basic educational piece about dry eye causes that includes a solid list of non-drug practical steps for managing chronic dry eye. Thumbs up.
25 July: Dry eye dangers are often missed
USA Today. Humph. I wonder if the journalist was aware that dry eye is the #1 side effect of LASIK when they went and got a quote from a prominent laser surgeon. And the NWHRC gets their little plug in for Restasis... again. Pass.
25 July: Symptoms, causes, treatments for dry eye
The Arizona Republic: "Here's information to help you prevent, identify and treat the problem of dry eye...." Thoroughly respectable article.
23 July: Menopause can cause dry eye syndrome
10 News: "...Dry eye syndrome is a common condition endured by menopausal and peri-menopausal women...." Decent read.
20 July: Can-Fite Initiated Phase IIb Clinical Trials in Rheumatoid Arthritis Patients... blah blah
Genengnews.com: "the Company will shortly begin evaluating the efficacy of this drug in the treatment of dry eye syndrome..." I love the word "shortly". Fine, keep saying it, but we sure hope you actually DO it soon.
19 July: International Group Targets Sjögrens Syndrome
UCSF Today: The Sjögren's International Collaborative Clinical Alliance (SICCA) met in DC recently.... This is a group of clinical and laboratory investigators focusing on the development of the International Sjögren's Syndrome Registry. Don't know much about this organization but it's good to have one out there promoting research on prevention & treatments.
17 July: Alimera Sciences Announces Agreement with CYNACON / OCuSOFT(R), to Co-Promote OCuSOFT(R) Lid Scrub Eyelid Cleanser
PRNewsWire: Whole story in the title. This is probably a good thing as it will increase awareness of the importance of lid hygiene. Presumably prompted in part by the launch of TheraTears Sterilid product.
12 July: Sinclair Pharma: Opthalmology Product Gets Regulatory OK
Sinclair press release page: New product released in the UK as a medical device class I (sterile). From the limited information in the press release it is not clear whether this really presents some truly new or improved kind of mechanism or is basically a souped up artificial tear marketed as a prescription drug. Waiting on more info from Sinclair about active ingredients and preservatives.
1 July: New study puts the focus on dry eye
The Salt Lake Tribune: Bragging about being the seventh worst city for dry eye. Good article overall.
Monday, July 31, 2006
Dry Eye Hot Spots
From the editor's desk
July 1, 2006
NEW TO THE DRY EYE ZONE? Let me introduce myself... My name is Rebecca and I run this website and company and write the newsletter and that's all you need to know about me right now, although you'll probably learn a bit more along the way if you do much reading on this website or on Dry Eye Talk. (By the way... if you haven't registered on Talk yet, please do. It's free, it's easy, it's a terrific group of people and we get into some fascinating discussions on anything and everything related to dry eye.) If you ever need to get in touch with me, you can always reach me by email or phone.
YES, THIS IS NOW A MONTHLY! I finally bit the bullet. Mind you, I was actually rather attached to my original concept of an 'irregular' newsletter. What's the fun in being predictable? Unfortunately, the reality is that I've always been one of those deadline-oriented people... you know, the ones that always wrote the report at 3 am the day before it was due? No hard & fast deadline meant it just never seemed to get done and much as I enjoy catching up on medical literature, it's always been the first to go when the daily fires push things off the bottom of the priority list and onto the do-it-sometime stack. Last time I tried to lift the stack, I found it was heavier than my daughter. So, it was time for a change. From now on, deo volente, you'll be seeing new stuff on these pages around the beginning of each month.
WHAT THIS PAGE IS FOR: Every now and then I get the urge to ramble about something.
So, on to this month's ramble....
Dry Eye Hot Spots (NWHRC)
National Women's Health Resource Center recently released a list of their assessment of the top 100 cities with environmental conditions most likely to aggravate dry eye. But if you figure they're all in Nevada, just because the list starts with Las Vegas, you're way off (after all, how many cities ARE there in Nevada?).
The rankings were produced with a weighted average of the following six criteria:
altitude
humidity levels
pollution
temperature
wind
ocular allergy irritants
Of course, we could have saved them a lot of time and money by letting them know that you really only need one criterion: AIR CONDITIONING (or HEATING, depending on your latitude.) Did you feel that breeze? It was the collective sighs of 15 million fellow Florida residents, rapidly followed by those of 10 million in Michigan. But hey, nobody asked us, and who are we to butt in anyway.
It's an interesting list, and it's spawned at least a little coverage, including Forbes and Medical News Today (UK) so far. If nothing else it's going to give lots of people bragging rights. Make that complaining rights. ('After all, I live in the 6th worst dry eye city in America!')
Anyway, here's the top 25 in NWHRC's list. I've taken the liberty of correcting their typing. Well, maybe they did mean to have two twos, nineteens, twenty-sixes and so on, but it still looks funny. For the complete list of 100, click here.
LAS VEGAS, Nevada. (No-brainer, even without factoring in the smoke in the casinos.)
EL PASO, Texas.
LUBBOCK, Texas. (Home of the first international symposium on dry eye back in 1984, ironically but not coincidentally.)
MIDLAND/ODESSA, Texas.
DALLAS/FORT WORTH, Texas. (Do I sense a pattern here?)
ATLANTA, Georgia. (Proof at last that humidity is not a cureall for dry eye.)
SALT LAKE CITY, Utah. (Naw.)
PHOENIX, Arizona. (Average high temperature this month is 105 degrees.)
AMARILLO, Texas. (At that size surely they could have lumped it with Lubbock. On second thought they might as well have listed 'West Texas'.)
HONOLULU, Hawaii. (Don't worry, if you were justifying your vacation on the basis it will help your eyes just switch to Kauai.)
OKLAHOMA CITY, Oklahoma.
ALBUQUERQUE, New Mexico. (Last time I tried to get some advice for a patient there, the doctors just rolled their eyes and said 'She needs to move.')
TUCSON, Arizona.
NORFOLK, Virginia (And they call this urban renewal?)
NEWARK, New Jersey. (OK I'll stop now.)
BOSTON, Massachusetts. (Oops, I take it back. Beantown residents with dry eye at least have some great nearby resources for treatment.)
DENVER, Colorado.
PITTSBURGH, Pennsylvania.
BAKERSFIELD, California.
WICHITA, Kansas.
DAYTON, Ohio.
KANSAS CITY, Missouri.
NEW YORK, New York.
PHILADELPHIA, Pennsylvania.
BALTIMORE, Maryland.
Our headquarters (Tampa) came in at a respectable #45. I'm surprised that Houston was way down there at #79 - seems like we get calls from dry eye patients in Houston every other day.
I have a strange, nagging feeling about this list. Ah, yes, I've got it now! Somebody please tell me what the point of it is, other than to make headlines. I mean seriously, now that you've ruled out every major metropolitan area where the sun shines more frequently than Seattle and Portland, and most of the small towns in Texas, where is someone with dry eye and money to burn supposed to pull up roots and move to? Can't you at least give us a hint, like which Caribbean islands are most benign for dry eye?
Now pardon me while I go write the newsletter, before my first attempt at a schedule goes up in smoke! See you in a month.
Rebecca Petris
The Dry Eye Zone
July 1, 2006
NEW TO THE DRY EYE ZONE? Let me introduce myself... My name is Rebecca and I run this website and company and write the newsletter and that's all you need to know about me right now, although you'll probably learn a bit more along the way if you do much reading on this website or on Dry Eye Talk. (By the way... if you haven't registered on Talk yet, please do. It's free, it's easy, it's a terrific group of people and we get into some fascinating discussions on anything and everything related to dry eye.) If you ever need to get in touch with me, you can always reach me by email or phone.
YES, THIS IS NOW A MONTHLY! I finally bit the bullet. Mind you, I was actually rather attached to my original concept of an 'irregular' newsletter. What's the fun in being predictable? Unfortunately, the reality is that I've always been one of those deadline-oriented people... you know, the ones that always wrote the report at 3 am the day before it was due? No hard & fast deadline meant it just never seemed to get done and much as I enjoy catching up on medical literature, it's always been the first to go when the daily fires push things off the bottom of the priority list and onto the do-it-sometime stack. Last time I tried to lift the stack, I found it was heavier than my daughter. So, it was time for a change. From now on, deo volente, you'll be seeing new stuff on these pages around the beginning of each month.
WHAT THIS PAGE IS FOR: Every now and then I get the urge to ramble about something.
So, on to this month's ramble....
Dry Eye Hot Spots (NWHRC)
National Women's Health Resource Center recently released a list of their assessment of the top 100 cities with environmental conditions most likely to aggravate dry eye. But if you figure they're all in Nevada, just because the list starts with Las Vegas, you're way off (after all, how many cities ARE there in Nevada?).
The rankings were produced with a weighted average of the following six criteria:
altitude
humidity levels
pollution
temperature
wind
ocular allergy irritants
Of course, we could have saved them a lot of time and money by letting them know that you really only need one criterion: AIR CONDITIONING (or HEATING, depending on your latitude.) Did you feel that breeze? It was the collective sighs of 15 million fellow Florida residents, rapidly followed by those of 10 million in Michigan. But hey, nobody asked us, and who are we to butt in anyway.
It's an interesting list, and it's spawned at least a little coverage, including Forbes and Medical News Today (UK) so far. If nothing else it's going to give lots of people bragging rights. Make that complaining rights. ('After all, I live in the 6th worst dry eye city in America!')
Anyway, here's the top 25 in NWHRC's list. I've taken the liberty of correcting their typing. Well, maybe they did mean to have two twos, nineteens, twenty-sixes and so on, but it still looks funny. For the complete list of 100, click here.
LAS VEGAS, Nevada. (No-brainer, even without factoring in the smoke in the casinos.)
EL PASO, Texas.
LUBBOCK, Texas. (Home of the first international symposium on dry eye back in 1984, ironically but not coincidentally.)
MIDLAND/ODESSA, Texas.
DALLAS/FORT WORTH, Texas. (Do I sense a pattern here?)
ATLANTA, Georgia. (Proof at last that humidity is not a cureall for dry eye.)
SALT LAKE CITY, Utah. (Naw.)
PHOENIX, Arizona. (Average high temperature this month is 105 degrees.)
AMARILLO, Texas. (At that size surely they could have lumped it with Lubbock. On second thought they might as well have listed 'West Texas'.)
HONOLULU, Hawaii. (Don't worry, if you were justifying your vacation on the basis it will help your eyes just switch to Kauai.)
OKLAHOMA CITY, Oklahoma.
ALBUQUERQUE, New Mexico. (Last time I tried to get some advice for a patient there, the doctors just rolled their eyes and said 'She needs to move.')
TUCSON, Arizona.
NORFOLK, Virginia (And they call this urban renewal?)
NEWARK, New Jersey. (OK I'll stop now.)
BOSTON, Massachusetts. (Oops, I take it back. Beantown residents with dry eye at least have some great nearby resources for treatment.)
DENVER, Colorado.
PITTSBURGH, Pennsylvania.
BAKERSFIELD, California.
WICHITA, Kansas.
DAYTON, Ohio.
KANSAS CITY, Missouri.
NEW YORK, New York.
PHILADELPHIA, Pennsylvania.
BALTIMORE, Maryland.
Our headquarters (Tampa) came in at a respectable #45. I'm surprised that Houston was way down there at #79 - seems like we get calls from dry eye patients in Houston every other day.
I have a strange, nagging feeling about this list. Ah, yes, I've got it now! Somebody please tell me what the point of it is, other than to make headlines. I mean seriously, now that you've ruled out every major metropolitan area where the sun shines more frequently than Seattle and Portland, and most of the small towns in Texas, where is someone with dry eye and money to burn supposed to pull up roots and move to? Can't you at least give us a hint, like which Caribbean islands are most benign for dry eye?
Now pardon me while I go write the newsletter, before my first attempt at a schedule goes up in smoke! See you in a month.
Rebecca Petris
The Dry Eye Zone
Saturday, July 1, 2006
Journal Roundup
Journal Roundup
American Journal of Ophthalmology
Smoking and dry eye: The title of this study (below) in the June issue pretty much says it all. The difference between smokers and controls was actually quite remarkable - smoking more than halved TBUT, for example (5.41 in smokers, 11.20 in controls) and reduced corneal sensitivity by about a third. Smoking associated with damage to the lipid layer of the ocular surface. Altinors et al, AJO June 2006 Vol 141 No 6 Pp 1016-1021. Click here for abstract.
Archives of Ophthalmology
Research on immunoinflammatory responses continues: This study at Schepens identifies a chemokine receptor as a potentially useful target in developing treatments for dry eye. Chemokine receptor CCR5 expression in conjunctival epithelium of patients with dry eye syndrome. Gulati et al, Arch Ophthalmol 2006 May;124(5):710-6. Click here for abstract.
BMC Ophthalmology
Fluorophotometer useful in dry eye diagnosis? Based on the abstract the results sound pretty impressive. However all they were testing was people with low Schirmer scores. We'd be interested to hear how this fares with patients who are symptomatic without being excessively aqueous deficient. Fluorophotometry as a diagnostic tool for the evaluation of dry eye disease. Fahim et al, BMC Ophthalmology, 2006 May 26;6(1):20. Click here for abstract.
Bone Marrow Transplantation
Autologous serum eyedrop contamination risks. In this study of HPCT patients, 32% had dry eye. Of interest and concern to us is their finding that six of 11 autologous serum eyedrop samples were contaminated after 30 days of use. We can't afford to subscribe to every journal on the planet but we sure would be interested to know what their AST preparation and handling protocols were like. Risk factors and characteristics of ocular complications, and efficacy of autologous serum tears after haematopoietic progenitor cell transplantation. Leite et al, Bone Marrow Transplant, 2006 Jun 19; [Epub ahead of print]. Click here for abstract.
Ceska a Slovenska Oftalmologie
A glowing report on SmartPlugs. Overwhelmingly positive results both in terms of visual performance and alleviation of symptoms and signs of dry eye. Wish they'd commented on duration & extrusion rates in the abstract since we can't read Czech. Visual functions' detailed evaluating in patients with Sjogren's syndrome before and after intracanalicular implants' (Smart Plug) insertion--(first results). Hejcmanova et al, Cesk Slov Oftalmol 2006 May;62(3):183-9. Click here for abstract.
Chinese Journal of Integrative Medicine
Something other than drops, drugs and plugs: We'll be lazy and simply quote from this very readable abstract, just this once: "The authors are making a comprehensive discussion on the methods and curative effects of treating dry eye by traditional Chinese medicine and by integrative Chinese and Western medicine in recent years, so as to introduce the distinctive features of the traditional Chinese medicine and integrative Chinese and Western medicine in this field." A survey on treatment of dry eye by traditional chinese medicine and integrative chinese and Western medicine. Zhou et al, Chin J Integred Med, 2006 Jun;12(2):154-9. Click here for abstract.
Cornea
New SmartPlug complication: A case report in the May issue of Cornea details two separate incidents of pyogenic granuloma formation two years after insertion of SmartPlugs. One case required surgery; in the other, the growth got smaller after the plug was irrigated out. Pyogenic granuloma formation following placement of the Medennium SmartPLUG punctum plug. Chou et al, Cornea May 2006 Vol 25 No 4 Pp 493-495. Click here for abstract.
The sexy side of dry eye: The title's a bit of a mouthful (no pun, er, never mind) and it's predictably technical but for those of you following hormonal research in ocular surface disease, see this study on sex steroids: 'Identification of Steroidogenic Enzyme mRNAs in the Human Lacrimal Gland, Meibomian Gland, Cornea and Conjunctiva' presented by Schirra et al (Cornea, May 2006, Vol 25 No 4 Pp 438-442).
Experimental Eye Research
One of those again... There oughtta be a law against abstracts with an average of more than 10 syllables per word. Especially since with authors like these, we know this stuff is important and we want to understand it. The title is crystal clear but we confess to getting crossed eyes in the middle of the first sentence. Corticosteroid and doxycycline suppress MMP-9 and inflammatory cytokine expression, MAPK activation in the corneal epithelium in experimental dry eye. De Paiva et al, Exp Eye Res 2006 Sep;83(3):526-35. Epub 2006 Apr 27. Click here for abstract.
Eye & Contact Lens
Care for popcorn while you watch 'em duke it out? Allergan vs. Alcon, round 362. (Refresh Liquigel vs Systane.) Suitable for amusement if not information: follow-up period was a grand total of 7 days. Allergan wins this round. Comparison of initial treatment response to two enhanced-viscosity artificial tears. Noecker. Eye & Contact Lens, 2006 May;32(3):148-52. Click here for abstract.
International Review of Cytology
Cell and molecular biology of human lacrimal gland and nasolacrimal duct mucins. Paulsen F. Int Rev Cytol 2006;249:229-79. Click here for abstract.
Investigative Ophthalmology & Visual Science
Apical corneal barrier disruption in experimental murine dry eye is abrogated by methylprednisolone and doxycycline. De Paiva et al. Inv Ophthal & Vis Sci, 2006 Jul;47(7):2847-56. Click here for abstract.
Conjunctival cytokine expression in symptomatic moderate dry eye subjects. Narayanan et al, Invest Ophthal & Vis Sci 2006 Jun;47(6):2445-50. Click here for abstract.
Another dry eye diagnostic: Appears to correlate very well with other objective diagnostic testing. We'd be interested to know whether & how it correlates with symptoms. Strip meniscometry: a new and simple method of tear meniscus evaluation. Dogru et al, Invest Ophthal & Vis Sci 2006 May;47(5):1895-901. Click here for abstract.
Journal of Cataract & Refractive Surgery
Publish all you want, but... We still won't applaud any of you for trying to figure out ways to do LASIK on people with pre-existing dry eye. However, if the patients are going to get it done no matter what we say, we're not displeased to hear that you're paying attention to the specific effects of dry eye drops of various sorts after surgery. Safety and efficacy of cyclosporine 0.05% drops versus unpreserved artificial tears in dry-eye patients having laser in situ keratomileusis. Salib et al, Jour Cat Refract Surg, 2006 May;32(5):772-8. Click here for abstract
Journal of Ocular Pharmacology and Therapeutics
Anything to relieve the burning, doc! Patients in this study seemed both happier and better off with Keterolac during their initiation to Restasis. Ketorolac during the induction phase of cyclosporin-A therapy. Schechter. Jour Ocul Pharmacol Ther, 2006 Apr;22(2):150-4. Click here for abstract.
Journal of Refractive Surgery
Careful with the wonderdrug du jour, please: Mitomycin C is becoming increasingly popular of late as a means of reducing the risk of subepithelial corneal haze in PRK patients, but rational guidelines for its use are about as scarce as knowledge of the long-term risks, as pointed out in two recent studies in the Journal of Refractive Surgery: 1) According to a case study presented in May's issue, intraoperative use of mitomycin C during PRK may induce or exacerbate tear deficiency. See Dry eye after photorefractive keratectomy with adjuvant mitomycin C, Kymionis et al, Jour Refract Surg 2006 May 22;5 pp 511-513 or click here for abstract. 2) For an excellent and rather sobering study about MMC, see Effect of Prophylactic and Therapeutic Mitomycin C on Corneal Apoptosis, Cellular Proliferation, Haze, and Long-term Keratocyte Density in Rabbits, Netto et al, Jour Refract Surg 2006 Jun 22;6; click here for abstract. Sigh - still no free lunch for high myopes getting refractive surgery.
Ophthalmologica
Of red eyes and dry eyes: This is an interesting survey of ophthalmologists and GPs from 9 eastern European and middle eastern countries who recorded details of all visits from patients with red eyes for a 20-day period. 25% of patients were diagnosed with dry eye. GPs were apparently exceedingly aggressive with the topical antibiotics and steroids. The differential diagnosis of red eye: a survey of medical practitioners from eastern europe and the middle East. Petricek et al, Ophthalmologica, 2006;220(4):229-37. Click here for abstract.
Orbit
Dry eye plus dry eye equals.... Something like blepharoplasty after LASIK? (shudder). Upper lid blepharoplasty in patients with LASIK. Griffin et al, Orbit 2006 Jun;25(2):103-6. Click here for abstract.
Progress in Histochemistry and Cytochemistry
Sounds interesting. Now if we only knew what it meant. Difficult to formulate any intelligible summary from the abstract, but this is a topic of intense interest to us so if a subscriber to the publication feels any burning desire to share some of the details, we'd be all ears. Mucins and TFF peptides of the tear film and lacrimal apparatus. Paulsen et al, Prog Histochem Cytochem, 2006 Jul 17;41(1):1-53. Epub 2006 May 23. Click here for abstract.
American Journal of Ophthalmology
Smoking and dry eye: The title of this study (below) in the June issue pretty much says it all. The difference between smokers and controls was actually quite remarkable - smoking more than halved TBUT, for example (5.41 in smokers, 11.20 in controls) and reduced corneal sensitivity by about a third. Smoking associated with damage to the lipid layer of the ocular surface. Altinors et al, AJO June 2006 Vol 141 No 6 Pp 1016-1021. Click here for abstract.
Archives of Ophthalmology
Research on immunoinflammatory responses continues: This study at Schepens identifies a chemokine receptor as a potentially useful target in developing treatments for dry eye. Chemokine receptor CCR5 expression in conjunctival epithelium of patients with dry eye syndrome. Gulati et al, Arch Ophthalmol 2006 May;124(5):710-6. Click here for abstract.
BMC Ophthalmology
Fluorophotometer useful in dry eye diagnosis? Based on the abstract the results sound pretty impressive. However all they were testing was people with low Schirmer scores. We'd be interested to hear how this fares with patients who are symptomatic without being excessively aqueous deficient. Fluorophotometry as a diagnostic tool for the evaluation of dry eye disease. Fahim et al, BMC Ophthalmology, 2006 May 26;6(1):20. Click here for abstract.
Bone Marrow Transplantation
Autologous serum eyedrop contamination risks. In this study of HPCT patients, 32% had dry eye. Of interest and concern to us is their finding that six of 11 autologous serum eyedrop samples were contaminated after 30 days of use. We can't afford to subscribe to every journal on the planet but we sure would be interested to know what their AST preparation and handling protocols were like. Risk factors and characteristics of ocular complications, and efficacy of autologous serum tears after haematopoietic progenitor cell transplantation. Leite et al, Bone Marrow Transplant, 2006 Jun 19; [Epub ahead of print]. Click here for abstract.
Ceska a Slovenska Oftalmologie
A glowing report on SmartPlugs. Overwhelmingly positive results both in terms of visual performance and alleviation of symptoms and signs of dry eye. Wish they'd commented on duration & extrusion rates in the abstract since we can't read Czech. Visual functions' detailed evaluating in patients with Sjogren's syndrome before and after intracanalicular implants' (Smart Plug) insertion--(first results). Hejcmanova et al, Cesk Slov Oftalmol 2006 May;62(3):183-9. Click here for abstract.
Chinese Journal of Integrative Medicine
Something other than drops, drugs and plugs: We'll be lazy and simply quote from this very readable abstract, just this once: "The authors are making a comprehensive discussion on the methods and curative effects of treating dry eye by traditional Chinese medicine and by integrative Chinese and Western medicine in recent years, so as to introduce the distinctive features of the traditional Chinese medicine and integrative Chinese and Western medicine in this field." A survey on treatment of dry eye by traditional chinese medicine and integrative chinese and Western medicine. Zhou et al, Chin J Integred Med, 2006 Jun;12(2):154-9. Click here for abstract.
Cornea
New SmartPlug complication: A case report in the May issue of Cornea details two separate incidents of pyogenic granuloma formation two years after insertion of SmartPlugs. One case required surgery; in the other, the growth got smaller after the plug was irrigated out. Pyogenic granuloma formation following placement of the Medennium SmartPLUG punctum plug. Chou et al, Cornea May 2006 Vol 25 No 4 Pp 493-495. Click here for abstract.
The sexy side of dry eye: The title's a bit of a mouthful (no pun, er, never mind) and it's predictably technical but for those of you following hormonal research in ocular surface disease, see this study on sex steroids: 'Identification of Steroidogenic Enzyme mRNAs in the Human Lacrimal Gland, Meibomian Gland, Cornea and Conjunctiva' presented by Schirra et al (Cornea, May 2006, Vol 25 No 4 Pp 438-442).
Experimental Eye Research
One of those again... There oughtta be a law against abstracts with an average of more than 10 syllables per word. Especially since with authors like these, we know this stuff is important and we want to understand it. The title is crystal clear but we confess to getting crossed eyes in the middle of the first sentence. Corticosteroid and doxycycline suppress MMP-9 and inflammatory cytokine expression, MAPK activation in the corneal epithelium in experimental dry eye. De Paiva et al, Exp Eye Res 2006 Sep;83(3):526-35. Epub 2006 Apr 27. Click here for abstract.
Eye & Contact Lens
Care for popcorn while you watch 'em duke it out? Allergan vs. Alcon, round 362. (Refresh Liquigel vs Systane.) Suitable for amusement if not information: follow-up period was a grand total of 7 days. Allergan wins this round. Comparison of initial treatment response to two enhanced-viscosity artificial tears. Noecker. Eye & Contact Lens, 2006 May;32(3):148-52. Click here for abstract.
International Review of Cytology
Cell and molecular biology of human lacrimal gland and nasolacrimal duct mucins. Paulsen F. Int Rev Cytol 2006;249:229-79. Click here for abstract.
Investigative Ophthalmology & Visual Science
Apical corneal barrier disruption in experimental murine dry eye is abrogated by methylprednisolone and doxycycline. De Paiva et al. Inv Ophthal & Vis Sci, 2006 Jul;47(7):2847-56. Click here for abstract.
Conjunctival cytokine expression in symptomatic moderate dry eye subjects. Narayanan et al, Invest Ophthal & Vis Sci 2006 Jun;47(6):2445-50. Click here for abstract.
Another dry eye diagnostic: Appears to correlate very well with other objective diagnostic testing. We'd be interested to know whether & how it correlates with symptoms. Strip meniscometry: a new and simple method of tear meniscus evaluation. Dogru et al, Invest Ophthal & Vis Sci 2006 May;47(5):1895-901. Click here for abstract.
Journal of Cataract & Refractive Surgery
Publish all you want, but... We still won't applaud any of you for trying to figure out ways to do LASIK on people with pre-existing dry eye. However, if the patients are going to get it done no matter what we say, we're not displeased to hear that you're paying attention to the specific effects of dry eye drops of various sorts after surgery. Safety and efficacy of cyclosporine 0.05% drops versus unpreserved artificial tears in dry-eye patients having laser in situ keratomileusis. Salib et al, Jour Cat Refract Surg, 2006 May;32(5):772-8. Click here for abstract
Journal of Ocular Pharmacology and Therapeutics
Anything to relieve the burning, doc! Patients in this study seemed both happier and better off with Keterolac during their initiation to Restasis. Ketorolac during the induction phase of cyclosporin-A therapy. Schechter. Jour Ocul Pharmacol Ther, 2006 Apr;22(2):150-4. Click here for abstract.
Journal of Refractive Surgery
Careful with the wonderdrug du jour, please: Mitomycin C is becoming increasingly popular of late as a means of reducing the risk of subepithelial corneal haze in PRK patients, but rational guidelines for its use are about as scarce as knowledge of the long-term risks, as pointed out in two recent studies in the Journal of Refractive Surgery: 1) According to a case study presented in May's issue, intraoperative use of mitomycin C during PRK may induce or exacerbate tear deficiency. See Dry eye after photorefractive keratectomy with adjuvant mitomycin C, Kymionis et al, Jour Refract Surg 2006 May 22;5 pp 511-513 or click here for abstract. 2) For an excellent and rather sobering study about MMC, see Effect of Prophylactic and Therapeutic Mitomycin C on Corneal Apoptosis, Cellular Proliferation, Haze, and Long-term Keratocyte Density in Rabbits, Netto et al, Jour Refract Surg 2006 Jun 22;6; click here for abstract. Sigh - still no free lunch for high myopes getting refractive surgery.
Ophthalmologica
Of red eyes and dry eyes: This is an interesting survey of ophthalmologists and GPs from 9 eastern European and middle eastern countries who recorded details of all visits from patients with red eyes for a 20-day period. 25% of patients were diagnosed with dry eye. GPs were apparently exceedingly aggressive with the topical antibiotics and steroids. The differential diagnosis of red eye: a survey of medical practitioners from eastern europe and the middle East. Petricek et al, Ophthalmologica, 2006;220(4):229-37. Click here for abstract.
Orbit
Dry eye plus dry eye equals.... Something like blepharoplasty after LASIK? (shudder). Upper lid blepharoplasty in patients with LASIK. Griffin et al, Orbit 2006 Jun;25(2):103-6. Click here for abstract.
Progress in Histochemistry and Cytochemistry
Sounds interesting. Now if we only knew what it meant. Difficult to formulate any intelligible summary from the abstract, but this is a topic of intense interest to us so if a subscriber to the publication feels any burning desire to share some of the details, we'd be all ears. Mucins and TFF peptides of the tear film and lacrimal apparatus. Paulsen et al, Prog Histochem Cytochem, 2006 Jul 17;41(1):1-53. Epub 2006 May 23. Click here for abstract.
Thursday, June 15, 2006
Newsclips: June 2006
Dry Eye in the News
Editor's note: We are so pleased to see the increase in general press coverage of dry eye! We don't even begrudge seeing several months of warmed-over articles about the Harvard tuna study and thinly veiled infomercials for 'the only prescription dry eye drug' while we patiently await some good quality in-depth health coverage. It's enough to know that dry eye is finding its way into the news more and more so that people can learn about what it is and how they can get help. And hey, if you're a reporter interested in writing some of that 'good quality in-depth health coverage' about dry eye, we'd love to help, so give us a call.
30 June: Dry Eye Hot Spots
Forbes' coverage of the NWHRA top 100 dry eye hot spots in the USA list. Also covered on our editorial page.
28 June: Texas Tops Nation's Dry-Eye Spots
Ditto from NBC5 in Dallas/Fort Worth, bragging about their state nabbing 4 of the top 5 dry eye rankings.
28 June: Consuming Omega 3s could reduce dry eye in women
What was that we were saying about warmed-over coverage of the Harvard report? No no, that's OK, we really do sincerely applaud the Rock River Times' efforts, truly we do. And Jeff, you've outdone yourself. We got no fewer than 7 pages of Google hits on 'tuna and gilbard and dry eye'.
23 June: Clinical Trial Targets Cure for Dry Eyes
NBC5 again. Coverage of Dr. McCulley's (UTSW) clinical trial on benefits of Omega 3s for dry eye.
22 June: Some treatment for dry eye and mouth
UPI. About as inspired and informative as the title.
20 June: The Drug CF101 Is Not Metabolized in the Liver and Can Be Used as Potential Therapy for Liver Related Conditions
Genetic Engineering News. Can-Fite BioPharma Ltd is planning another clinical trial of CF101 as a treatment for dry eye symptoms.
12 June: PDA Users Reporting Eye Strain Problems
NBC10. Well, duh, did you really think reading a 2" screen would be easier than reading a 20" monitor? But the article at least has the merit of pointing out that staring at a screen causes dry eye symptoms.
1 June: Tear production
From WSOC-TV. Wow - the introductory paragraphs are really quite a respectable overview of dry eye! Nice going. And we luuuv reports that don't just focus on drugs but get to the practical quality-of-life aids like eyewear, humidifiers and so on. The rest of the article is about saliva gland transplants as a dry eye treatment.
Editor's note: We are so pleased to see the increase in general press coverage of dry eye! We don't even begrudge seeing several months of warmed-over articles about the Harvard tuna study and thinly veiled infomercials for 'the only prescription dry eye drug' while we patiently await some good quality in-depth health coverage. It's enough to know that dry eye is finding its way into the news more and more so that people can learn about what it is and how they can get help. And hey, if you're a reporter interested in writing some of that 'good quality in-depth health coverage' about dry eye, we'd love to help, so give us a call.
30 June: Dry Eye Hot Spots
Forbes' coverage of the NWHRA top 100 dry eye hot spots in the USA list. Also covered on our editorial page.
28 June: Texas Tops Nation's Dry-Eye Spots
Ditto from NBC5 in Dallas/Fort Worth, bragging about their state nabbing 4 of the top 5 dry eye rankings.
28 June: Consuming Omega 3s could reduce dry eye in women
What was that we were saying about warmed-over coverage of the Harvard report? No no, that's OK, we really do sincerely applaud the Rock River Times' efforts, truly we do. And Jeff, you've outdone yourself. We got no fewer than 7 pages of Google hits on 'tuna and gilbard and dry eye'.
23 June: Clinical Trial Targets Cure for Dry Eyes
NBC5 again. Coverage of Dr. McCulley's (UTSW) clinical trial on benefits of Omega 3s for dry eye.
22 June: Some treatment for dry eye and mouth
UPI. About as inspired and informative as the title.
20 June: The Drug CF101 Is Not Metabolized in the Liver and Can Be Used as Potential Therapy for Liver Related Conditions
Genetic Engineering News. Can-Fite BioPharma Ltd is planning another clinical trial of CF101 as a treatment for dry eye symptoms.
12 June: PDA Users Reporting Eye Strain Problems
NBC10. Well, duh, did you really think reading a 2" screen would be easier than reading a 20" monitor? But the article at least has the merit of pointing out that staring at a screen causes dry eye symptoms.
1 June: Tear production
From WSOC-TV. Wow - the introductory paragraphs are really quite a respectable overview of dry eye! Nice going. And we luuuv reports that don't just focus on drugs but get to the practical quality-of-life aids like eyewear, humidifiers and so on. The rest of the article is about saliva gland transplants as a dry eye treatment.
Thursday, June 1, 2006
Drug Pipeline
Phase III Clinicals (or thereabouts)
OTSUKA-NOVARTIS/REBAMIPIDE: Phase III clinical trials ongoing. This still seems to be the furthest along of anything in the current pipeline, though we're hearing rumors of, er, 'issues' from current or former study sites. And we've heard some modestly positive reports. Click here for initial screening checklist and list of study centers.
NOVAGALI/NOVA22007: Cyclosporine emulsion. Recently started Phase III clinicals after obtaining new funding. Click here for most recent press release.
NASCENT/ iDESTRIN (NP50301): Estrogen ester compound (topical eyedrop). Phase IIb clinical completed, now all we need is money to move forward. Latest report was in early January (click here for press release) stating good results from Phase IIb with "no drug related serious adverse effects". Click here for Nascent's page.
SENJU-ISTA/ECABET SODIUM: Mucin secretagogue. Expecting to start Phase III trials in 2007, having reported positive results from Phase IIb studies in February 06. Ista claim that this is the first drug to show efficacy in clinicals against both signs and symptoms of dry eye. Click here for most recent press release and here for ISTA's main (albeit very outdated) page on this.
Phase II clinicals
NOVARTIS / PIMECROLIMUS (AMS981): Recruiting for Phase II clinicals. Click here for more info (or patients interested in signing up click here).
LANTIBIO/MOLI1901: Currently undergoing Phase II trials in the US following positive results in european Phase I studies. Click here for a, uh, colorful graphic about the mechanism of action. What is it? Cystic fibrosis drug being attempted as a dry eye treatment.
Somewhere in limbo
ALLERGAN/ANDROGEN TEARS: Hellloooo, anybody out there? Last we heard something was supposed to be presented at ARVO. Was it? Does anybody know anything? Some Phase IIs had been completed. We are anxious to see this drug on the market. Why has everything come to a standstill since Allergan took it on? Anybody with intelligence about developments please let us know.
INSPIRE/"PROLACRIA" (DIQUAFOSOL TETRASODIUM): We flipped a coin and decided they'd opt for DNR in late April but we were apparently wrong. They now have a name for the product, if nothing else. We haven't seen anything really fresh about their FDA 'discussions'. Click here for Inspire's inspiring pages about it.
On the horizon
CAN-FITE/BIOPHARMA/CF-101: CF101 is currently in clinical trials as a treatment for rheumatoid arthritis. The company has announced that it will shortly initiate another clinical study to test the drug's efficacy in treating dry eye symptoms. Click here for more.
OTHERA/OT-551: This is in Phase II clinical for preventing cataracts in patients who have undergone vitrectomy. Othera has stated they expect to begin Phase II clinicals for two additional indications, AMD and dry eye syndrome, next year. Click here for more.
SENJU/LACRITIN: It's very early stages yet but we've been keeping an eye on this for well over a year and think it's one of the most interesting and promising things coming down the pipeline. Some results of rabbit eye studies presented at ARVO recently. Click here for some updates & abstract from ARVO posted in Dry Eye Talk.
PAI-2: Research being done at University of Pennsylvania and Temple University; data presented at ARVO recently. Not a whole lot of info but it sounds interesting. Click here for more.
Obituaries
ALCON/15-HETE: Mucin secretagogue. We never actually read an official 'dead in the water' notice anywhere so we've been kindly keeping this on the roster in hopes its resuscitation or death would become easier to confirm. Nothing came to our attention so this is the last time we will list it.
OTSUKA-NOVARTIS/REBAMIPIDE: Phase III clinical trials ongoing. This still seems to be the furthest along of anything in the current pipeline, though we're hearing rumors of, er, 'issues' from current or former study sites. And we've heard some modestly positive reports. Click here for initial screening checklist and list of study centers.
NOVAGALI/NOVA22007: Cyclosporine emulsion. Recently started Phase III clinicals after obtaining new funding. Click here for most recent press release.
NASCENT/ iDESTRIN (NP50301): Estrogen ester compound (topical eyedrop). Phase IIb clinical completed, now all we need is money to move forward. Latest report was in early January (click here for press release) stating good results from Phase IIb with "no drug related serious adverse effects". Click here for Nascent's page.
SENJU-ISTA/ECABET SODIUM: Mucin secretagogue. Expecting to start Phase III trials in 2007, having reported positive results from Phase IIb studies in February 06. Ista claim that this is the first drug to show efficacy in clinicals against both signs and symptoms of dry eye. Click here for most recent press release and here for ISTA's main (albeit very outdated) page on this.
Phase II clinicals
NOVARTIS / PIMECROLIMUS (AMS981): Recruiting for Phase II clinicals. Click here for more info (or patients interested in signing up click here).
LANTIBIO/MOLI1901: Currently undergoing Phase II trials in the US following positive results in european Phase I studies. Click here for a, uh, colorful graphic about the mechanism of action. What is it? Cystic fibrosis drug being attempted as a dry eye treatment.
Somewhere in limbo
ALLERGAN/ANDROGEN TEARS: Hellloooo, anybody out there? Last we heard something was supposed to be presented at ARVO. Was it? Does anybody know anything? Some Phase IIs had been completed. We are anxious to see this drug on the market. Why has everything come to a standstill since Allergan took it on? Anybody with intelligence about developments please let us know.
INSPIRE/"PROLACRIA" (DIQUAFOSOL TETRASODIUM): We flipped a coin and decided they'd opt for DNR in late April but we were apparently wrong. They now have a name for the product, if nothing else. We haven't seen anything really fresh about their FDA 'discussions'. Click here for Inspire's inspiring pages about it.
On the horizon
CAN-FITE/BIOPHARMA/CF-101: CF101 is currently in clinical trials as a treatment for rheumatoid arthritis. The company has announced that it will shortly initiate another clinical study to test the drug's efficacy in treating dry eye symptoms. Click here for more.
OTHERA/OT-551: This is in Phase II clinical for preventing cataracts in patients who have undergone vitrectomy. Othera has stated they expect to begin Phase II clinicals for two additional indications, AMD and dry eye syndrome, next year. Click here for more.
SENJU/LACRITIN: It's very early stages yet but we've been keeping an eye on this for well over a year and think it's one of the most interesting and promising things coming down the pipeline. Some results of rabbit eye studies presented at ARVO recently. Click here for some updates & abstract from ARVO posted in Dry Eye Talk.
PAI-2: Research being done at University of Pennsylvania and Temple University; data presented at ARVO recently. Not a whole lot of info but it sounds interesting. Click here for more.
Obituaries
ALCON/15-HETE: Mucin secretagogue. We never actually read an official 'dead in the water' notice anywhere so we've been kindly keeping this on the roster in hopes its resuscitation or death would become easier to confirm. Nothing came to our attention so this is the last time we will list it.
Saturday, April 1, 2006
April 2006 Dry Eye News
The Latest Dope
Editor's note: We can't possibly cover everything that's happened in the last six months (eeps, is it really that long since we put out a fresh newsletter?), so this is a bit of a random collection. Enjoy.
THE FIRST ANNUAL SAFETY HARBOR DRY EYE SYMPOSIUM was quietly held on February 17-19 at the Safety Harbor Resort & Spa (near Tampa, FL). We won't attempt to describe it other than to say that it was altogether unique and, judging from the feedback from patients and speakers, a resounding success. We'll let you know when dates are set for next year's. We make no secret of the fact that one of our modest ambitions in undertaking patient education events like this is to goad the industry into offering the public more real education amid the infomercials.
SLEEPING WITH YOUR EYES OPEN? Dr. Latkany's excellent overview and classification of nocturnal lagophthalmos in the January issue of The Ocular Surface (Vol 4, No 1) should be required reading. Seriously. Amid all the exciting pharmacological and surgical developments in ocular surface disease, we fear that the more mundane basics from eyelid mechanics to meibomian glands are getting, at best, lip-service rather than proper clinical investigation and treatment. Click here and scroll down for a brief summary. But you really need to get hold of the full article and read the whole thing or at least sections V and VII.
A CHEEKY NEW TWIST ON AMT? In February's AJO, Inatomi et al reported results of a complex ocular surface reconstruction technique designed for severe cases such as Stevens-Johnson patients. The general idea is to redeploy stem cells from the mouth in the eye; materials included amniotic membrane, oral mucosa and (in some cases) autologous serum. See "Midterm results on ocular surface reconstruction using cultivated autologous oral mucosal epithelial transplantation", Am J Ophth 2006;141:267-275 (click here for abstract - and if you subscribe, see also Scheffer Tseng's excellent background article on pp. 356-7).
SPEAKING OF AMT, AN UPDATE ON THE NON-SURGICAL FRONT: A small case series presented by Parmar et al in February's AJO about AMT applied with a collagen corneal shield and supported by a soft contact sounds very promising, showing good safety and efficacy with in fact complete resolution of persistent epithelial defects in the three eyes studied. See "Ocular surface restoration using non-surgical transplantation of tissue-cultured human amniotic epithelial cells", Am J Ophth 2006;141:299-307 (click here for abstract). We are looking forward to seeing more.
STILL PLUGGING AWAY: A study in January's Cornea (Atelocollagen punctal occlusion in dry eye patients, Miyata et al, Cornea 2006;25:47-50, click here for abstract) found atelocollagen plugs to improve ocular surface disorders for up to 8 weeks after insertion. It also nicely summed up concerns about problems associated with other types of plugs, such as extrusion, migration, infection and discomfort. Meanwhile, a brief report in February's AJO (Clinical evaluation of the Smart Plug (TM) in the treatment of dry eyes, Kojima et al, AmJ Oph 2006;141:386-388) confirmed our main concern with these otherwise attractive (e.g. easy to insert, very comfortable) plugs: We still don't know where the heck they go once they're in. Out the other end three days later? Or some indeterminate location where they partially block tears without much altering Schirmer scores? Click here for abstract.
IF NO NEWS IS GOOD NEWS, WHAT IS NEWSLESS NEWS? In an unprecedentedly content-rich press release, we learned the other day that Inspire had a meeting with the FDA in which they discussed providing further information to the FDA in order to discuss how to have further discussions about diquafosol. Not that we've been holding our breaths or anything. Don't bother clicking here for press release.
MUCINS, MEIBOMIANS AND MORE: We found this fascinating, despite the content being at a level you might expect when co-authors include six PhDs: "The surface activity of purified ocular mucin at the air-liquid interface and interactions with meibomian lipids", Millar et al, Cornea 2006;25:91-100 (click here for abstract). On a side note, fans of sodium hyaluronate tears might be interested to see these authors' findings about surface activity of hyaluronic acid and its relevance to use of HA in tears.
AND IF YOU CAN STOMACH AN AVERAGE OF 16 SYLLABLES PER WORD, this study of “dry eye” in terms of mucosal immune regulation is quite interesting. (Mucosal Immunity and Self-Tolerance in the Ocular Surface System, Austin K. Mircheff, PhD et al, The Ocular Surface; 2005;4:182-193 Vol 3: No 4.) In terms of implications for therapy, it discusses systemic hormonal replacement, local gene transfer therapy, and cellular immunotherapy. Click here for article.
BUT HERE IS WHERE WE DRY THE LINE (REALLY): As a matter of principle your editor flatly refuses to read and summarize studies whose titles extend half a page vertically. Nevertheless, being personally acquainted with individuals suffering severe epiphora she is loathe to pass over a study that might be relevant and hereby refers the inquisitive amongst us to Parts I and II of a study about lacrimal duct obstruction by Sasaki et al in December AJO. Click here for the first abstract and here for the second.
LANGUAGE BUFFS might enjoy Juan Murube’s meanderings through language history, even if it does perhaps get a teensy bit too ambitious in its scope: “Etymology of the Term ‘Tear’, The Ocular Surface; 2005;4:177-181 Vol 3: No 4. If you ever wondered what “tear” is called in Albanian, Old Irish or Frisian, now’s your chance. Click here for full article.
BLOODY GOOD FOR LASIKED BUNNIES: In November's Cornea Esquenazi et al reported on some interesting work with autologous serum to treat post LASIK epithelial defects in rabbits. "Use of autologous serum in corneal epithelial defects post-lamellar surgery", Cornea 2005;24:992-997, click here for abstract.
WHAT TAKES 3 YEARS LONGER FOR A LASIK PATIENT THAN A PRK PATIENT? Recovery of subbasal nerve density, according to a study in the December issue of AJO. In "Recovery of corneal subbasal nerve density after PRK and LASIK" (J. Erie MD et al, Am J Oph 2005;140:1059-1064, click here for abstract) it took 2 years after PRK and 5 years after LASIK for nerve density to recover to near preoperative levels.
OF FORESTS, TREES, LASERS AND DRY EYES: Don't miss "The incidence and risk factors for developing dry eye after myopic lasik", Cintia de Paiva MD et al, Am J Oph 2006;141:438-445 (click here for abstract). The ink was probably still wet when the arguing began about the definition of dry eye, the relevance of corneal staining, and the price of legumes in large Asian countries. We dare to opine that a conclusion of "Dry eye occurs commonly after LASIK surgery in patients with no history of dry eye....", supported by numbers like "36.36% at 6 months" and with names like Pflugfelder and Koch wafting through the credits, speaks for itself, and describes a forest more interesting for its sheer acreage than its leaf veining patterns. Somebody in December's JCRS seems to be on that page too: "The grittiness, burning sensation, ocular irritation, foreign-body sensation, photophobia, diplopia, and fluctuation of vision with blinking that are associated with dry eyes have been frequently reported after LASIK" (Chen et al, "LASEK for dry eye associated with soft contact lenses", J Cat Refr Surg 2005;31:2299-2305, click here for abstract.) But the inspiring faith that has long characterized the practice of LASIK will no doubt prevail over the ravings of us skeptics. Adeste fideles, perscribamus restasis.
What’s in the pipeline?
Phase III clinical trials (or thereabouts)
OTSUKA-NOVARTIS/REBAMIPIDE: Phase III clinical trials ongoing. This seems to be the furthest along of anything in the current pipeline, but there is no news and little gossip to report since our last update. We've heard some modestly positive reports. Click here for initial screening checklist and list of study centers. Participants receive higher or lower dose or placebo.
NOVAGALI/NOVA22007: Expecting to start Phase III trials in 2006, having announced completion of Phase II in January which reportedly demonstrated safety and "trends towards efficacy". What is it? Cyclosporine emulsion. Click here for press release. *April 12 update: Per Novagali press release they are in Phase III now, and have new funding.
NASCENT/ iDESTRIN (NP50301): Phase IIb clinical completed. Latest report was in early January (click here for press release) stating good results from Phase IIb with "no drug related serious adverse effects". What it is: Topical ophthalmic therapeutic eye drop for treating dry eye in postmenopausal women.
SENJU-ISTA/ECABET SODIUM: Expecting to start Phase III trials in 2007, having reported positive results from Phase IIb studies in February 06. Ista claim that this is the first drug to show efficacy in clinicals against both signs and symptoms of dry eye. What is it? Mucin secretagogue. Click here for most recent press release.
Phase II or I
NOVARTIS / PIMECROLIMUS (AMS981): Recruiting for Phase II clinicals. Click here for more info (or patients interested in signing up click here).
LANTIBIO/MOLI1901: Currently undergoing Phase II trials in the US following positive results in european Phase I studies. Click here for a, uh, colorful graphic about the mechanism of action. What is it? Cystic fibrosis drug being attempted as a dry eye treatment.
ALLERGAN/ANDROGEN TEARS: Alive but not visibly kicking. Some Phase IIs had been completed (data to be presented at ARVO). Grapevine says that Allergan will be restarting some new trials before long. We are anxious to see this on the market considering many positive reports from doctors and patients, but thus far it seems to be on a slow boat headed nobody knows quite where. We'll post updates if we get any new info.
Dumb, dormant, defunct or dead
INSPIRE/DIQUAFOSOL: Expect them to announce whether or not they've opted for DNR "by the end of April 2006". Click here for Inspire's inspiring page about diquafosol.
ALCON/15-HETE: We haven't read an obit yet, but neither have we seen any signs of life or resuscitation teams in a year or so.
(Obit) SUCAMPO/TACROLIMUS: Sucampo announced last June that despite completion of Phase II safety and efficacy study, it was voluntarily suspending its tacrolimus eye drops development program because of FDA safety concerns about Protopic®, a prescription cream for treating atopic dermatitis marketed by Astellas Pharma, Inc. Click here for press release.
Have we missed anything? Email it to us at newseditor@dryeyezone.com.
In the spotlight this issue
BOSTON SCLERAL LENS
Mark Cohen, Executive Director of the Boston Foundation for Sight, was kind enough to be a guest speaker at our Safety Harbor dry eye symposium in February. While we already knew some dry eye patients who had benefitted from sclerals, Mark's presentation and Q&A was as illuminating as it was impressive, as it dispelled many of our misconceptions about the device and revealed very impressive success rates.
Some of the aspects of the work being done at BSF that are most interesting to us at this time and which motivate us to seek to raise awareness about this treatment modality include (a) successful use of the lens in dry eye patients whose quality of life has been dramatically impacted by their symptoms but who do not present with the extreme clinical signs traditionally associated with advanced corneal disease, and (b) its use as a prophylactic device to prevent patients with chronic ocular surface disease from reaching the point where they would require corneal transplantation.
For patients who are unfamiliar with sclerals and how they are used in dry eye, we provide answers to a few frequently asked questions below. For physicians who are aware of sclerals but have never considered them an option for a patient of their own with advanced corneal disease, we would like to encourage you to contact the Foundation for information about the wide variety of patients accepted for treatment.
A few brief Q&A for patients:
WHAT IS A SCLERAL LENS? A scleral lens is a very large gas permeable lens. It does not touch the cornea (central, sensitive clear covering of the eye) at all, and therefore does not hurt, move around or stick the way a normal gas perm lens might. Instead, the edges rest on the tougher sclera (white of the eye).
WHAT IS IT FOR AND HOW DOES IT WORK? The purpose of the scleral lens is to provide a sort of liquid bandage for your cornea. Each time you put the lens in, you first fill it up with artificial tears and then put it on the eye. So the lens is basically holding a resevoir of fluid over your eye all day long, which will reduce pain and light sensitivity and improve vision.
HOW BIG IS IT? About the size of a quarter.
DO I WEAR IT 24X7? No, normally you would only wear it during the day.
CAN MY OWN EYE DOCTOR ORDER SCLERALS FOR ME? No, scleral lenses have to be individually designed for your eyes by specialists.
Patients, for answers to many more questions about sclerals, please visit this link or contact BSF.
DOCTORS AND PATIENTS, for further information please visit www.bostonsight.org or contact the Boston Foundation for Sight (Telephone (781)-726-7337 or email info@bostonsight.org).
Editor's note: We can't possibly cover everything that's happened in the last six months (eeps, is it really that long since we put out a fresh newsletter?), so this is a bit of a random collection. Enjoy.
THE FIRST ANNUAL SAFETY HARBOR DRY EYE SYMPOSIUM was quietly held on February 17-19 at the Safety Harbor Resort & Spa (near Tampa, FL). We won't attempt to describe it other than to say that it was altogether unique and, judging from the feedback from patients and speakers, a resounding success. We'll let you know when dates are set for next year's. We make no secret of the fact that one of our modest ambitions in undertaking patient education events like this is to goad the industry into offering the public more real education amid the infomercials.
SLEEPING WITH YOUR EYES OPEN? Dr. Latkany's excellent overview and classification of nocturnal lagophthalmos in the January issue of The Ocular Surface (Vol 4, No 1) should be required reading. Seriously. Amid all the exciting pharmacological and surgical developments in ocular surface disease, we fear that the more mundane basics from eyelid mechanics to meibomian glands are getting, at best, lip-service rather than proper clinical investigation and treatment. Click here and scroll down for a brief summary. But you really need to get hold of the full article and read the whole thing or at least sections V and VII.
A CHEEKY NEW TWIST ON AMT? In February's AJO, Inatomi et al reported results of a complex ocular surface reconstruction technique designed for severe cases such as Stevens-Johnson patients. The general idea is to redeploy stem cells from the mouth in the eye; materials included amniotic membrane, oral mucosa and (in some cases) autologous serum. See "Midterm results on ocular surface reconstruction using cultivated autologous oral mucosal epithelial transplantation", Am J Ophth 2006;141:267-275 (click here for abstract - and if you subscribe, see also Scheffer Tseng's excellent background article on pp. 356-7).
SPEAKING OF AMT, AN UPDATE ON THE NON-SURGICAL FRONT: A small case series presented by Parmar et al in February's AJO about AMT applied with a collagen corneal shield and supported by a soft contact sounds very promising, showing good safety and efficacy with in fact complete resolution of persistent epithelial defects in the three eyes studied. See "Ocular surface restoration using non-surgical transplantation of tissue-cultured human amniotic epithelial cells", Am J Ophth 2006;141:299-307 (click here for abstract). We are looking forward to seeing more.
STILL PLUGGING AWAY: A study in January's Cornea (Atelocollagen punctal occlusion in dry eye patients, Miyata et al, Cornea 2006;25:47-50, click here for abstract) found atelocollagen plugs to improve ocular surface disorders for up to 8 weeks after insertion. It also nicely summed up concerns about problems associated with other types of plugs, such as extrusion, migration, infection and discomfort. Meanwhile, a brief report in February's AJO (Clinical evaluation of the Smart Plug (TM) in the treatment of dry eyes, Kojima et al, AmJ Oph 2006;141:386-388) confirmed our main concern with these otherwise attractive (e.g. easy to insert, very comfortable) plugs: We still don't know where the heck they go once they're in. Out the other end three days later? Or some indeterminate location where they partially block tears without much altering Schirmer scores? Click here for abstract.
IF NO NEWS IS GOOD NEWS, WHAT IS NEWSLESS NEWS? In an unprecedentedly content-rich press release, we learned the other day that Inspire had a meeting with the FDA in which they discussed providing further information to the FDA in order to discuss how to have further discussions about diquafosol. Not that we've been holding our breaths or anything. Don't bother clicking here for press release.
MUCINS, MEIBOMIANS AND MORE: We found this fascinating, despite the content being at a level you might expect when co-authors include six PhDs: "The surface activity of purified ocular mucin at the air-liquid interface and interactions with meibomian lipids", Millar et al, Cornea 2006;25:91-100 (click here for abstract). On a side note, fans of sodium hyaluronate tears might be interested to see these authors' findings about surface activity of hyaluronic acid and its relevance to use of HA in tears.
AND IF YOU CAN STOMACH AN AVERAGE OF 16 SYLLABLES PER WORD, this study of “dry eye” in terms of mucosal immune regulation is quite interesting. (Mucosal Immunity and Self-Tolerance in the Ocular Surface System, Austin K. Mircheff, PhD et al, The Ocular Surface; 2005;4:182-193 Vol 3: No 4.) In terms of implications for therapy, it discusses systemic hormonal replacement, local gene transfer therapy, and cellular immunotherapy. Click here for article.
BUT HERE IS WHERE WE DRY THE LINE (REALLY): As a matter of principle your editor flatly refuses to read and summarize studies whose titles extend half a page vertically. Nevertheless, being personally acquainted with individuals suffering severe epiphora she is loathe to pass over a study that might be relevant and hereby refers the inquisitive amongst us to Parts I and II of a study about lacrimal duct obstruction by Sasaki et al in December AJO. Click here for the first abstract and here for the second.
LANGUAGE BUFFS might enjoy Juan Murube’s meanderings through language history, even if it does perhaps get a teensy bit too ambitious in its scope: “Etymology of the Term ‘Tear’, The Ocular Surface; 2005;4:177-181 Vol 3: No 4. If you ever wondered what “tear” is called in Albanian, Old Irish or Frisian, now’s your chance. Click here for full article.
BLOODY GOOD FOR LASIKED BUNNIES: In November's Cornea Esquenazi et al reported on some interesting work with autologous serum to treat post LASIK epithelial defects in rabbits. "Use of autologous serum in corneal epithelial defects post-lamellar surgery", Cornea 2005;24:992-997, click here for abstract.
WHAT TAKES 3 YEARS LONGER FOR A LASIK PATIENT THAN A PRK PATIENT? Recovery of subbasal nerve density, according to a study in the December issue of AJO. In "Recovery of corneal subbasal nerve density after PRK and LASIK" (J. Erie MD et al, Am J Oph 2005;140:1059-1064, click here for abstract) it took 2 years after PRK and 5 years after LASIK for nerve density to recover to near preoperative levels.
OF FORESTS, TREES, LASERS AND DRY EYES: Don't miss "The incidence and risk factors for developing dry eye after myopic lasik", Cintia de Paiva MD et al, Am J Oph 2006;141:438-445 (click here for abstract). The ink was probably still wet when the arguing began about the definition of dry eye, the relevance of corneal staining, and the price of legumes in large Asian countries. We dare to opine that a conclusion of "Dry eye occurs commonly after LASIK surgery in patients with no history of dry eye....", supported by numbers like "36.36% at 6 months" and with names like Pflugfelder and Koch wafting through the credits, speaks for itself, and describes a forest more interesting for its sheer acreage than its leaf veining patterns. Somebody in December's JCRS seems to be on that page too: "The grittiness, burning sensation, ocular irritation, foreign-body sensation, photophobia, diplopia, and fluctuation of vision with blinking that are associated with dry eyes have been frequently reported after LASIK" (Chen et al, "LASEK for dry eye associated with soft contact lenses", J Cat Refr Surg 2005;31:2299-2305, click here for abstract.) But the inspiring faith that has long characterized the practice of LASIK will no doubt prevail over the ravings of us skeptics. Adeste fideles, perscribamus restasis.
What’s in the pipeline?
Phase III clinical trials (or thereabouts)
OTSUKA-NOVARTIS/REBAMIPIDE: Phase III clinical trials ongoing. This seems to be the furthest along of anything in the current pipeline, but there is no news and little gossip to report since our last update. We've heard some modestly positive reports. Click here for initial screening checklist and list of study centers. Participants receive higher or lower dose or placebo.
NOVAGALI/NOVA22007: Expecting to start Phase III trials in 2006, having announced completion of Phase II in January which reportedly demonstrated safety and "trends towards efficacy". What is it? Cyclosporine emulsion. Click here for press release. *April 12 update: Per Novagali press release they are in Phase III now, and have new funding.
NASCENT/ iDESTRIN (NP50301): Phase IIb clinical completed. Latest report was in early January (click here for press release) stating good results from Phase IIb with "no drug related serious adverse effects". What it is: Topical ophthalmic therapeutic eye drop for treating dry eye in postmenopausal women.
SENJU-ISTA/ECABET SODIUM: Expecting to start Phase III trials in 2007, having reported positive results from Phase IIb studies in February 06. Ista claim that this is the first drug to show efficacy in clinicals against both signs and symptoms of dry eye. What is it? Mucin secretagogue. Click here for most recent press release.
Phase II or I
NOVARTIS / PIMECROLIMUS (AMS981): Recruiting for Phase II clinicals. Click here for more info (or patients interested in signing up click here).
LANTIBIO/MOLI1901: Currently undergoing Phase II trials in the US following positive results in european Phase I studies. Click here for a, uh, colorful graphic about the mechanism of action. What is it? Cystic fibrosis drug being attempted as a dry eye treatment.
ALLERGAN/ANDROGEN TEARS: Alive but not visibly kicking. Some Phase IIs had been completed (data to be presented at ARVO). Grapevine says that Allergan will be restarting some new trials before long. We are anxious to see this on the market considering many positive reports from doctors and patients, but thus far it seems to be on a slow boat headed nobody knows quite where. We'll post updates if we get any new info.
Dumb, dormant, defunct or dead
INSPIRE/DIQUAFOSOL: Expect them to announce whether or not they've opted for DNR "by the end of April 2006". Click here for Inspire's inspiring page about diquafosol.
ALCON/15-HETE: We haven't read an obit yet, but neither have we seen any signs of life or resuscitation teams in a year or so.
(Obit) SUCAMPO/TACROLIMUS: Sucampo announced last June that despite completion of Phase II safety and efficacy study, it was voluntarily suspending its tacrolimus eye drops development program because of FDA safety concerns about Protopic®, a prescription cream for treating atopic dermatitis marketed by Astellas Pharma, Inc. Click here for press release.
Have we missed anything? Email it to us at newseditor@dryeyezone.com.
In the spotlight this issue
BOSTON SCLERAL LENS
Mark Cohen, Executive Director of the Boston Foundation for Sight, was kind enough to be a guest speaker at our Safety Harbor dry eye symposium in February. While we already knew some dry eye patients who had benefitted from sclerals, Mark's presentation and Q&A was as illuminating as it was impressive, as it dispelled many of our misconceptions about the device and revealed very impressive success rates.
Some of the aspects of the work being done at BSF that are most interesting to us at this time and which motivate us to seek to raise awareness about this treatment modality include (a) successful use of the lens in dry eye patients whose quality of life has been dramatically impacted by their symptoms but who do not present with the extreme clinical signs traditionally associated with advanced corneal disease, and (b) its use as a prophylactic device to prevent patients with chronic ocular surface disease from reaching the point where they would require corneal transplantation.
For patients who are unfamiliar with sclerals and how they are used in dry eye, we provide answers to a few frequently asked questions below. For physicians who are aware of sclerals but have never considered them an option for a patient of their own with advanced corneal disease, we would like to encourage you to contact the Foundation for information about the wide variety of patients accepted for treatment.
A few brief Q&A for patients:
WHAT IS A SCLERAL LENS? A scleral lens is a very large gas permeable lens. It does not touch the cornea (central, sensitive clear covering of the eye) at all, and therefore does not hurt, move around or stick the way a normal gas perm lens might. Instead, the edges rest on the tougher sclera (white of the eye).
WHAT IS IT FOR AND HOW DOES IT WORK? The purpose of the scleral lens is to provide a sort of liquid bandage for your cornea. Each time you put the lens in, you first fill it up with artificial tears and then put it on the eye. So the lens is basically holding a resevoir of fluid over your eye all day long, which will reduce pain and light sensitivity and improve vision.
HOW BIG IS IT? About the size of a quarter.
DO I WEAR IT 24X7? No, normally you would only wear it during the day.
CAN MY OWN EYE DOCTOR ORDER SCLERALS FOR ME? No, scleral lenses have to be individually designed for your eyes by specialists.
Patients, for answers to many more questions about sclerals, please visit this link or contact BSF.
DOCTORS AND PATIENTS, for further information please visit www.bostonsight.org or contact the Boston Foundation for Sight (Telephone (781)-726-7337 or email info@bostonsight.org).
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