Thursday, September 15, 2005

September 2005 - Dry Eye News

The Latest Dope

DRY EYE GOES MAINSTREAM: It started just weeks ago with chatty little Dry Eye 101 courses sprouting like mushrooms on the health pages of obscure newspapers. Now they are spreading to TV. Well, perhaps they're more like Dry Eye 100 1/2. Come to think of it, one or two read rather suspiciously like Restasis 101. But seriously, we hope what we are seeing is the beginning of a trend in the general press which could do much to boost public awareness of dry eye causes, symptoms and appropriate treatment.

WANT TO BONE UP ON AMNIOTIC MEMBRANE TRANSPLANTATION DEVELOPMENTS? Try the August issue of Cornea. It opens with "Mother's own remedy for ocular surface disease", an editorial in which Dr. Kenyon outlines the best, so-so and questionable applications of AMT and discusses its limitations, variations, and likely future innovations. Further on, the references cited by Fernandes et al in their literature review of AMT for ocular surface reconstruction - all 146 of them - are a veritable AMT bible. (Amniotic membrane transplantation for ocular surface reconstruction, Fernandes et al, Cornea 2005;24(6) 643-653, click here for abstract.)

WHERE DO TEARS GO? (SERIOUSLY) A study in July's IOVS (Nichols et al, "Thinning Rate of the Precorneal and Prelens Tear Films" Inv Ophthal Vis Sci 2005;46:2353-2361) investigates what happens to tears between blinks in terms of evaporation, absorption by a lens or the epithelium, and movement across the surface, and suggests explanations for very rapid thinning. Click here for abstract.

t-PTK AND SERUM COMBINATION THERAPY Holzer et al studied 25 eyes which were treated for RCEs with transepithelial PTK followed by autologous serum, with 80% of eyes experiencing no further RCEs. The study (Jour Cat & Refract Surg, Vol 31 Aug 2005 1603-1606) includes some interesting comments on benefits of trying t-PTK before PTK and hypotheses about how t-PTK works. Click here for abstract.

MEIBOMIAN GLAND DYSFUNCTION + LASIK = DRY EYE? Scheffer Tseng and colleagues speculate that LASIK may aggravate pre-existing MGD and suggest taking this into account pre-operatively. They studied 17 patients for a year who had persistent dry eye more than a year after LASIK with poor TBUT despite punctal plugging. Click here for EyeWorld article.

TEAR FUNCTION IMPAIRED BY ANTI-VIRAL TREATMENT? A study in the July issue of Cornea (Huang MD et al, Cornea, 2005:24(5) 561-566) investigates objective and subjective dry eye conditions experienced by chronic hepatitis C patients undergoing interferon and ribavirin treatment. Click here for abstract.

GENTEAL GEL... ON THE WAY BACK AT LAST? Novartis have been, er, economical in their communications about the long absence of the popular Genteal Gel product but they recently added this to their website, perhaps to reduce phone calls from unhappy distributors and customers: "Novartis Ophthalmics truly understands and shares your frustrations with regards to access to GenTeal Gel. A substantial increase in GenTeal Gel supply will be available by October 2005." We will refrain from any sarcastic speculation about how much a substantial increase from zilch might be.

IT'S THAT BLINKING COMPUTER SCREEN A study in the July issue of Cornea (Miyake-Kashima MD et al, Cornea, 2005:24(5) 567-570) examined differences in blink rates while using a display terminal with or without antireflection films and found improved rates when the film is used. We were a little puzzled at their choice of DVD viewing as the task during which blink rates were analyzed (not being in the habit of viewing DVDs during our normal work day) but we certainly welcome publications drawing attention to the significance of blink rates. Click here for abstract. Or better yet just click here to get our must-have Blinkers.

WHAT, MICE DON'T LIKE THE A/C EITHER? A study in August's IOVS (Barabino et al, "The Controlled-Environment Chamber: A New Mouse Model of Dry Eye", Inv Ophth Vis Sci 2005;46:2766-2771) examined the effect of a low-humidity environment on tear film of mice. Tear secretion decreased, staining increased, and conjunctival goblet cell density significantly decreased. Click here for abstract.

AN OASYS FOR PATIENTS, IF NOT PATENT LAWYERS: J&J/Vistakon's new Oasys lens, a daily wear silicone hydrogel (senofilcon A) is making waves. Some verrry nice anecdotal reports floating our way from users. CIBA are apparently trying to get a restraining order (click here for Optometric Management article). We just hope the many ocular surface challenged consumers who want this type of lens innovation won't end up losing out yet again while the Contact Lens Wars rage on.

EPITHELIAL INNERVATION OF HUMAN CORNEA: Such is the title of an interesting study in the July issue of Cornea (Guthoff MD et al, Cornea 2005;24(5) 608-613) about a new method to get a complete picture of nerves in the central cornea using confocal laser scanning fluorescence microscopy. Click here for abstract.

IF WE ASK POLITELY ENOUGH will they someday stop ignoring dry eye in LASIK pre-op evaluations? A recent study (Sharma et al, Jour Refract Surg, Vol 21 No 5 p 496-498, click here for abstract) analyses reasons for not performing LASIK in refractive surgery candidates. It makes no reference to dry eye whatsoever, and the absence of dry eye testing from the list of pre-operative tests was particularly conspicuous. Last we checked, dry eye was still the number one lasting complication from LASIK, at least according to every ASCRS survey and informed consent we've ever laid eyes on.

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What’s in the pipeline?

OTSUKA-NOVARTIS/REBAMIPIDE: Phase III clinical trials continue. Click here for initial screening checklist and list of study centers. Participants receive higher or lower dose or placebo.

ALLERGAN/ANDROGEN TEARS: Phase II clinical trials going on... and on... and on. We don't have any official information on the latest delay but from what the grapevine is saying we're looking at late spring 2006 for the next milestone.

NASCENT/ NP50301: In Phase IIb clinicals. Topical ophthalmic therapeutic eye drop for treating dry eye in postmenopausal women.

NOVARTIS / PIMECROLIMUS (AMS981): Recruiting for Phase II clinicals. Click here for more info. We note that in a recent study pimecrolimus drops worked better for dogs than cyclosporine (click here and scroll down for abstract) though another study had a bit more equivocal results (click here for abstract). Incidentally you'd be less inclined to giggle over our doggy references if you ever asked your local veterinary ophthalmologist about the prevalence of canine dry eye.

INSPIRE/DIQUASOFOL: Inspire Pharmaceuticals submitted an amendment to its New Drug Application in June focusing this time on analysis of ocular surface staining and are awaiting response. Click here for Inspire's page on the drug.

SENJU-ISTA/ECABET SODIUM: Ista's secretagogue is in Phase IIb clinical studies which were expected to be completed in late 2005.

15-HETE/ALCON: No recent information on Alcon's secretagogue. Did we miss something, or is it just dead?

LANTIBIO/MOLI1901: Cystic fibrosis drug being attempted as a dry eye treatment. We don't know anything newer than the March announcement about starting Phase I clinicals (click here for announcement).

PORT PUNCTUM OCCLUDER/ALCON & LANDEC: Awaiting approval. See June/July issue for more details. We have heard some good reports from patients.

NEI/CYCLOSPORINE IMPLANT: NEI is recruiting patients for Phase I clinical trials of a subconjunctival cyclosporine implant for patients with GVHD (graft-vs-host-disease, which causes eye dryness and inflammation). It consists of a half-inch silicone implant with sustained-release cyclosporine, and is implanted in the conjunctiva for a year. Click here for details.

AND ACROSS THE POND, RESTASIS FANS TAKE NOTE: Novagali of France has a cyclosporine emulsion (NOVA22007) in Phase II clinical trials. Click here for company's page on this.

In the spotlight this issue

PRODUCT SPOTLIGHT: Panoptx DryEyeWear

Quality protective eyewear is without doubt one of the best-kept secrets in the chronic dry eye veteran's toolbox. Truly, we know of no other single product that can rival a top quality sunglass with vented medical grade foam surrounds when it comes to instantly, consistently and measureably improving quality of life for the chronically photophobic, pain-ridden ocular surface disease patient. Cure? Of course not. But not the less is it often a vital piece of equipment for struggling patients.

This has been so long evident to your editor from years of rave reviews from her savviest dry eye product connoisseur friends that one wonders why it took her until summer of 2005 to try it for herself. But like many dry eye patients, she thought of those "goggles" as an extreme treatment she just didn't need. One day in a pair of perfectly fitting Panoptx Sirroccos transformed her thinking. She was in fact rather shocked to discover, through the new sense of freedom the glasses gave her, how much discomfort she had evidently been suppressing and to what extent she had been evading outdoors activities because of photophobia and wind irritation.

If you're not familiar with the kind of eyewear we're talking about, basically they are very high-end sunglasses (though many can be had in clear lenses as well) with medical grade foam lining. Some styles have the lining built right in, others have a removeable gasket so that they can easily convert from protective to a simple fashionable sunglass. They are not airtight, but are designed to keep in moisture and keep out irritants. Such eyewear has developed a strong following amongst chronic dry eye patients. Brands include Harley Davidson and Panoptx (developed primarily for the biker market) and Wiley-X (developed primarily for military applications). Each has its advantageous features.

Panoptx, however, are the only ones who have specifically targeted the dry eye market. They have a set of products dubbed "DryEyeWear" which are designed with their patented Orbital Seal. The variety in their product line and the resources they have dedicated to this market make them a natural starting point for the dry eye patient or doctor. They have four "convertible" frame styles (with removeable eyecup) and four fixed eyecup styles, several frame colors, and several different grades of lenses. Many lenses are available in plano or Rx. Prices for plano glasses range from $85 for a fixed eyecup frame with plano baseline lens to $195 for convertible frame with plano polarized lens. Add a prescription and the price roughly doubles, or more.

They are not cheap. Nor are the competition - pricing from the other manufacturers is generally in a similar range. But increasingly, patients are consdering this money well spent, particularly as their annual budget for eyecare may well be in the thousands anyway.

We stock plano Panoptx in The Dry Eye Shop though that's intended more as an information service to patients than a sales effort. First time users really should not buy online but should seek out a local dealer so that they can try on all different frame styles. Doctors, if you have an optical shop you may want to consider becoming a dealer for these and/or similar eyewear as a service to local dry eye patients.

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Is there a product, treatment, website, book, organization, event or other resource you would like us to consider covering in a future issue? Email details to news@dryeyezone.com.

Wednesday, June 1, 2005

June 2005 - Dry Eye News

The Latest Dope

NEWLY IDENTIFIED PROTEIN may become key factor in developing new dry eye treatments. Discovered and named by Gordon Laurie at the University of Virginia, lacritin “may be involved in stimulating new tear production and, if so, could form the basis of a revolutionary treatment for dry-eye syndrome”, according to project lead Robert McKown at James Madison University. Click here for related news article.

THE LIFE IMPACT OF DRY EYE: A recent study (Mertzanus et al: The Relative Burden of Dry Eye in Patients’ Lives: Comparisons to a U.S. Normative Sample, IOVS 2005; 46:46-50) looks at the life impact of dry eye disease, and suggests more research be done in this area. Of course, we patients already know that, and even a brief visit to our online community forum Dry Eye TALK makes clear the potential for dramatic life impact from this painful condition. We applaud all efforts to scientifically quantify it. Click here for abstract.

MEDICAL JOURNALS WANT CLINICAL TRIAL DATA PUBLIC (hear, hear!): Editors of leading medical journals are calling for clinical trials to be entered in a free, central, publicly available registry and have declared their intent to make such registration a condition for consideration for publication, in an attempt to (among other benefits) reduce selective reporting. Click here for joint editorial from leading editors.

BACK AT LAST, BY POPULAR DEMAND (as the saying goes): After a several-year hiatus, popular lubricant eyedrops Dwelle, Dakrina and NutraTear are on the market, this time from patient-run venture The Dry Eye Company (Apollo Beach, Florida). Samples are available for physicians and consumers. Quantities are limited. Physicians click here for more information or to order samples, consumers click here for product information or to order free samples.

ARE YOUR WIPERS WORKING? This study (Korb et al, Lid wiper epitheliopathy and dry eye symptoms, Eye Contact Lens. 2005 Jan;31(1):2-8) is not exactly hot off the press (5 months old) but this being our first issue, we wanted to cover it because many of our readers are symptomatic dry eye patients who have normal Schirmer or TBUT scores. The study found wiper staining in 76% of symptomatic patients with otherwise normal clinical findings. Click here for abstract.

WHAT REALLY AFFECTS SURFACE PRESSURE? A fascinating study (Tragoulias et al, Surface Pressure Measurements of Human Tears and Individual Tear Film Components Indicate That Proteins Are Major Contributors to the Surface Pressure, Cornea: 24(2):189-200, 2005) investigates the role of tear proteins in determining surface tension of tears – thence tear film stability – and finds them to be major contributors, shedding doubt on common assumptions about the uniqueness of lipids and mucins in this function. Click here for abstract.

GENTEAL GEL SORELY MISSED: Genteal Gel (Novartis Ophthalmics) continues its conspicuous absence from pharmacy shelves. The Dry Eye Zone has been receiving complaints from US patients for months about regional shortages, with some now desperate patients even going to the length of trying to get it shipped in from Australia. According to Novartis, the product is not being discontinued, and as we went to press their latest word was that its “backorder” status was expected to be resolved by the end of the summer. Oh, and yes, the pun was intended. For more information, call 1-888-669-6682.

BLINKING ON THE JOB: A study published in Occupational and Environmental Medicine (P. Wolkoff et al, Eye complaints in the office environment: precorneal tear film integrity influenced by eye blinking efficiency, 2005;62:4-12) investigates work-related eye complaints involving the tear film, from the standpoint of indoor air science, occupational health, and ophthalmology. Click here for abstract.

RESTASIS PLUS: Many doctors have moved on from “Do I prescribe Restasis” to “My favourite drop to supplement Restasis is...” In addition to discussions such as in May’s Ophthalmology Management (subscription only), and a study suggesting Alcon’s Systane does a better job in combined therapy with Restasis than Allergan’s own OTC tears, we at The Dry Eye Zone have been hearing from many patients of a wide range of Restasis mates being advised, including several Rx eyedrops such as Acular.

EYELID TATTOOS & LASIK - A CRYING SHAME FOR THIS PATIENT: A case study in Ophthalmic Plastic and Reconstructive Surgery (T Kojima et al, Tear film and ocular surface abnormalities after eyelid tattooing, 2005 Jan; 21(1):69-71) discusses serious ocular surface woes of a patient with LASIK performed many years after eyelid tatooing. Click here for abstract.

DRY EYE AND LASIK – NOW WE’RE TALKING: After years of ASCRS surveys consistently showing dry eye as the number one complication of LASIK, this sore subject is finally seeping out of the peer-reviewed journals into popular medical news-reporting (did I say throwaways?) on a regular basis (count ‘em, 11 feature articles in EyeWorld’s May issue). This is consistent with the increased focus on dry eye observeable throughout eyecare circles in the last couple of years, particularly with the emergence of Restasis and Systane. With more than 30% of members of Dry Eye TALK reporting LASIK as the (or a) cause of their chronic dry eye, we worry that despite this welcome loquacity prospective customers (sorry, I mean patients) are not necessarily getting the right message.

EDITORIAL HUMOUR ALIVE AND KICKING (across the border, anyway): We are indebted for our chuckle of the month to the editors of the American Journal of Ophthalmology, who in their May issue called our attention to a study in the Canadian Medical Association Journal titled “Incidence and risk factors for nodding off at scientific sessions”. Click here for a riot (the study, that is).

What’s in the pipeline?

NOVARTIS/REBAMIPIDE (in-licensed by Novartis from developer Otsuka): Clinical trials ongoing. Rebamipide is a drug designed to “enhance tear secretion and increase the levels of mucin covering the conjunctiva and cornea”. It is currently in Phase III clinical trials with participants receiving higher or lower dose or placebo. Click here for initial screening checklist and list of study centers. See Dry Eye TALK for commentaries from participating members.

INSPIRE/DIQUASOFOL: Phase I and Phase II clinical trials completed. On June 1st Inspire Pharmaceuticals submitted an amendment to its New Drug Application focusing this time on analysis of ocular surface staining. Diquasofol is a drug designed to stimulate secretion of all three tear components (mucin, fluid and lipid). Click here for news report about the amendment. Click here for Inspire Pharmaceutical’s information page about the clinical trials.

NASCENT/ NP50301: Nascent Pharmaceuticals Inc. recently announced it has completed enrollment of a 90-patient Phase IIb clinical trial of NP50301, their topical ophthalmic therapeutic eye drop for treating dry eye in postmenopausal women.

NEI/CYCLOSPORINE IMPLANT: NEI is recruiting patients for Phase I clinical trials of a subconjunctival cyclosporine implant for patients with GVHD (graft-vs-host-disease, which causes eye dryness and inflammation). It consists of a half-inch silicone implant with sustained-release cyclosporine, and is implanted in the conjunctiva for a year. Click here for details.

PORT PUNCTUM OCCLUDER/ALCON & LANDEC: Clinical trials are complete, and product is awaiting approval. A brief report in Ocular Surgery News (June 15th) was just about the first we’d ever heard about this, and we didn’t find much info except a 4-year-old Review of Ophthalmology article which explains that it contains “temperature-activated Intelimer polymers which can be customized to change their physical characteristics abruptly when heated or cooled through a pre-set temperature switch. The PORT system involves liquifying a gel with gentle warming and injecting the fluid into the punctal openings where the lower temperature of adjacent tissue causes it to gel. You can remove the plug with gentle warming of the adjacent lid area.” Many patients we know will be attracted to the idea of a removeable plug... the perennial question for the sometime intracanalicular silicone plug-ee being “So is it still there or isn’t it, darn it?”.

NEI/DIGITAL PHOTOGRAPHY: And on the diagnostics side of the equation... A National Eye Institute sponsored study seeks to assess digital photography and compare it with the standard slit-lamp examination as a method of evaluating findings from ocular surface staining. Currently recruiting patients. Click here for details.