Wednesday, November 5, 2008

Diagnostics news: Occulogix submits 510(k) for TearLab

OccuLogix Submits 510(k) Premarket Notification for the Tearlab(TM) Osmolarity System

OccuLogix, Inc. (NASDAQ: OCCXD)(TSX: OC) announced today that its subsidiary, OcuSense, Inc., has submitted its 510(k) premarket notification to the US Food and Drug Administration (the FDA) for clearance to market the TearLab(TM) Osmolarity System and the TearLab(TM) Osmolarity Test Card in the United States.

As previously disclosed, the TearLab(TM) system recently obtained CE Marking and is currently being sold and marketed in five European countries through exclusive distributor agreements. In the United States, prior to 510(k) clearance from the FDA, the system is available for research use only.

Clinical Validation

The regulatory application included a study that validated the performance of the TearLab(TM) Osmolarity System when performed in physician office laboratories (POL) by health care professionals using human tear fluid collected from volunteer subjects. The study looked at:

- Usability

- Safety

- Clinical performance

The study involved three sites and enrolled 234 patients. The Company expects to release top-line data from the study at the American Academy of Ophthalmology (AAO) and European Society of Ophthalmology (SOE) 2008 Joint Meeting in November.

Study: Collagen bandage lenses

Suggesting that these may be a noticeable improvement on classic bandage lenses:

Clinical evaluation of succinylated collagen bandage lenses for ophthalmic applications.
Ophthalmic Res. 2008;40(5):257-66. Epub 2008 Apr 25.
Hadassah J, Prakash D, Sehgal PK, Agarwal A, Bhuvaneshwari N.

AIM: To study whether succinylated collagen bandage lenses (SCBL) prepared from modified bovine collagen (succinylated collagen) can replace other bandage lenses presently employed to treat various corneal conditions like filamentary keratitis, dry eyes, recurrent corneal erosions, foreign body removal and epithelial trauma. METHODS: This observational case study included 32 patients (22 female and 10 male): 8 patients for filamentary keratitis (25%), 10 patients for dry eyes (31%), 4 patients for recurrent corneal erosions (13%), 7 patients for foreign body removal (22%) and 3 patients for epithelial trauma (9%). Their eyes were evaluated for biocompatibility, in vivo transparency, patient comfort, corneal fit, best corrected visual acuity (BCVA), tear fluid level and dissolution rate of SCBL. This was carried out over a 24-hour period of time. RESULTS: SCBL exhibited good transparency and remained transparent throughout the period of study (between 0 and 24 h) in the eyes of patients. SCBL did not cause any irritation, discomfort and foreign body sensation in the eye and eyes remained comfortable throughout the experiment. BCVA in the control group of patients was 1.00 (20/20). Mean (+/-SD) BCVA before inserting SCBL (in decimal equivalent) was 0.31 (20/60) +/- 0.18 (range 0.1- 0.66). BCVA (+/-SD) changed to 0.25 (20/80) +/- 0.18 4 h after the application of SCBL and 0.27 (20/70) +/- 0.18 24 h after the application of SCBL, with a safety index of 1.20. The mean (+/-SD) tear fluid level before application of SCBL was 11.9 +/- 5.39 h (range 3-24 mm) and changed to 13.9 +/- 5.68 h (range 5-28 mm) after 4 h of application of SCBL and 15.9 +/- 5.72 h (range 7-30 mm) after 24 h with a safety index of 13 mm. The mean (+/-SD) dissolution rate of SCBL in the control group of patients was 17.8 +/- 8.65 h (range 10-24 h) and the mean (+/-SD) dissolution rate in the experimental group was 22.2 +/- 9.29 h (range 10-24 h). We report the use of SCBL in various corneal conditions. CONCLUSION: The present study showed that SCBL has complete corneal fit and good comfort in human eyes. Transparency was maintained for a longer period along with fair visual acuity and improvement in tear fluid levels. The disadvantages of other bandage lenses presently used to treat various corneal conditions could be overcome by the use of SCBL lenses.

Inspire update on Prolacria (diquafosol)

Inspire initiates special protocol assessment process for dry eye trial

Inspire Pharmaceuticals, a biopharmaceutical company, has submitted a clinical protocol and request for special protocol assessment to the FDA for a pivotal Phase III environmental trial with Prolacria for the treatment of dry eye disease.

The protocol is based on information from a detailed analysis of the overall Prolacria clinical trial data to date, including Inspire's Phase III trials and recently completed pilot trial, and consultation with the FDA, Allergan, Inspire's corporate partner, and other dry eye experts.

After detailed analysis, Inspire determined that designing and conducting a further environmental trial was a more appropriate course than further studies of Prolacria in a controlled adverse environment.

Allergan, dearest, you have really outdone yourselves this time

By unamimous vote of the membership of Dry Eye Talk, the prestigious Cheesiest Pharmaceutical Marketing Effort of the Year award goes to whoever in Allergan's marketing department came up with an idea which if it weren't so simply demented would be even more offensive:

The Dry Eye Book Club.

Read it and weep.

Honestly... sponsoring someone to write a tear-jerker as a way to "raise disease awareness" (a/k/a sell more drugs)?

Inviting people to join "The Dry Eye Book Club" - and when they click on the link, redirecting them to registration for the Optive Frequent Buyer program - which includes requirements like joining all the marketing lists?

I simply could not believe this when I saw it. I think if our members weren't so darned desperate, some of them would be throwing away their Restasis in protest.

Seriously, Allergan, if anyone out there is listening, here are just a few of my personal objections to this ad:

1. The whole idea insults the intelligence of the average human being and especially women.

2. If you're going to put a human face on dry eye, make them at least pretend to have REAL dry eye. It's an insult to the rest of us to suggest that someone whose most serious complaint is that she uses artificial tears "up to 5 times a day" suffers from chronic dry eye. For heaven's sakes, our DryEyeZone members would give their right hand to be able to survive on 5 artificial tear doses. Many use audio books because they can no longer read - tear-jerkers or otherwise.

3. Artistic license is fine in marketing but let's not stray quite that far from medical facts! We all know that the reflex type tears that we get from irritants or emotion are different from the balanced basal tears we so desperately need.

4. Choosing as the professional face for this ad a physician best known as a pioneer in refractive surgery... er... no offense whatsoever to Dr. McDonald who enjoys an excellent reputation, but A, did it never occur to you HOW some of us got our dry eyes?

Please, please scrap this nonsense and go back to classic infomercials.

Industry news/gossip: Restasis inventor lashes out

This tidbit reaches way back into the past of Restasis, when a professor at the University of Georgia first put cyclosporin into a solution to treat canine dry eye 20+ years ago.... Now that Restasis is a blockbuster drug for Allergan, there is some unhappiness out there about how the university where it all started has shortchanged itself and the inventor of the longterm rewards.

UGA research royalty deal sours

...UGA officials expect royalty and licensing income to set yet another record next year, mainly because of a $10 million payment due from the global pharmaceutical company Allergan....

But the research foundation's payments from the pharmaceutical company would be millions more if inexperienced UGA officials had not caved in to tougher negotiators from the drug company, according to the former UGA faculty member whose invention provided the basis for Restasis....

More than two decades ago, [Renee] Kaswan thought of something no one had tried before - putting the immunosuppressant drug cyclosporin into a solution so that it could be applied to the eyes of dogs suffering from dry eye....

Kaswan's second idea was even bigger than Optimmune, the dog dry eye drug. Why not use basically the same solution to cure dry eye in humans?

The U.S. Food and Drug Administration approved the new drug for human use in 2002. And in 2003, Allergan began marketing and selling the drug, which it called Restasis....

New product: Tranquileyes "stye care kit"

"Stye care kit" a/k/a single-eye Tranquileyes....

Click for details or to purchase in The Dry Eye Shop

What it is

This is Eye Eco's latest twist on the Tranquileyes theme. Here's what the kit consists of:
- One Tranquileyes eyecup
- Eye cushion and moisture pad (unlined type)
- Two Thermoeyes heat inserts
- Simple elastic band to hold eyecup on
- Mesh washbag for the moisture pad

How it's used

First, if you're new to Tranquileyes and Thermoeyes, I suggest you read up on both first.

The new twist here is using the thermoeyes on top of the moisture pad rather than underneath, so as to apply heat directly to the eyelid. Of course, some few of you are already doing this, with or without the goggle, because it's the only non-microwave, multi-use heat device available and suitable (so far as I know... let me know if there's any hidden gems out there I haven't heard of).

This was packaged specifically with styes in mind BUT I think there will be a variety of applications for them. Here are a few suggestions just off the top of my head:

Stye treatment (that's what the directions in the kit are for): Use the heat insert on top of the moisture pad. Since it has the regular (thick) moisture pad instead of a thermopad, this will put more pressure on the lid and hold the heat right where you want it.

Meibomian gland dysfunction, one eye at a time: What this single-eye kit will allow you to do is multitask... do heat on one eye while you're using the other eye.

Daytime rejuvenation, one eye at a time: Do your eyes get more and more painful as the day progresses? For a lot of people, giving your eyes a 20-30 minute break at some point during the day can make a huge difference - set the clock back, so to speak - and many use the tranquileyes goggle for that purpose. But not everybody can afford that much "downtime". If you're in an environment where you don't mind being seen with this, it would allow you to give one eye a moisturizing break while you continue working or doing other things. Then just switch eyes....

Night protection for a single eye. Now mind, I have not tried this myself so I cannot attest to how well it will stay on if you're tossing and turning. Usually if people only need to treat a single eye, I suggest that they get the full goggle and (if they want) remove the moisture pad from one side. But this is another alternative, and may be attractive especially for those who do not want to wake up "blind" in the middle of the night.

I'd love to have feedback on this and if you come up with other uses for it please let me know so I can share it with others here!

New product: MEGS (Micro-Environment Glasses)

The long-awaited MEGs are here! To see more pictures, get detailed information or purchase them, please visit the Seefit website.

The makers were kind enough to send me two pairs to try out. I've spent a fair amount of time wearing them and want to share my experience thus far.

Basic description: MEGs are the first commercial moisture chamber eyewear that can take high prescriptions. They are basically a simple pair of rimless glasses with a flexible, rubbery shield built all around them. You can purchase them with a "plano" (no prescription) lens or a "demo" lens to be replaced with prescription lenses that your local optician can put in them. (Please note that if you have a high prescription you may need to shop around for the right optician.)

Frame fit: I have a ladies small and medium. They both fit me fine and I could wear both all day without any discomfort. I tried the small pair on my daughter (6yo). They're too big on her :-) but they sure look cute.

Aesthetics: They are not as discreet as a really well done custom moisture chamber, but for indoor use they're far more 'aesthetically pleasing' than wearing foam-lined sunglasses or motorcycle goggles. Personally, I would not hesitate to wear these in an office environment if I needed to. Will others notice? Yes, but crucially, they are not distracting and unlike almost all alternatives they won't interfere in any way with eye contact.

Shield/Seal fit: Within the constraints of this type of product, I think they really did quite a good job.

Now, about those constraints. First, this is not a foam-lined product. The closest equivalent to this product would be the custom-cut Eagle Vision moisture chamber or custom chambers some optometrists are able to make. In a non-custom product like this where it has to fit all kinds of people, of course the shield can't go right to your skin, but it gets pretty close, at least for me, on the top and sides. Second, how close to the skin the shield can get is limited by the need to keep an effective vent to prevent fogging, which is a problem for any kind of moisture chamber. On me, and my sister who tried them for me (for reference, I have a round face and she has a much more slender oval face) there is a large gap at the bottom of the MEGs. It's my guess that this their way of minimizing fogging. All things considered if I'm going to have a gap, the bottom is where I'd want it.

What this means is that while it will provide good protection for a great many people, it will not be adequate for some people. Here's how I look at it: If you currently literally cannot get through the day without Panoptx style completely sealed glasses or custom moisture chambers, MEGs will probably not be an alternative for you. But that leaves a lot of people whom it WILL probably help a great deal. Here are some of the best uses for them I can think of:

1) People who WOULD be wearing moisture chambers if they could only get them with their glasses prescription.

2) People who WOULD be wearing moisture chambers at work if only they weren't so bulky or distracting and didn't interfere with eye contact.

3) People who CURRENTLY wear moisture chambers as much of the time as they can but leave them off specifically for aesthetic reasons in some circumstances.

4) People who have dry eye symptoms that are inadequately addressed with their current treatments, experience a lot of discomfort, and have never considered moisture chambers because... well... they can't face the idea of wearing goggles, or they don't think they're badly enough off for moisture chambers, etc.

Now that's just addressing the sorts of people we have most often on DryEyeTalk. Then of course there's a far larger audience that I think would benefit from these - namely, just about anybody working at a computer, especially the ones that are still wearing contact lenses.

Shield/seal efficacy: Sigh. On this, the single most important question, I can't give any useful feedback except to the extent it can be inferred from the seal fit description. I wear scleral lenses during the day, which keep me so comfortable that I wouldn't notice the difference of a moisture chamber indoors. I also rely on sclerals to see so I can't just leave them out for a day to give the MEGs a trial run. Sorry... Those of you who get the MEGs, I sure would appreciate it if you would post your comments on performance here and/or on DryEyeTalk.

Colors, styles, sizes: It comes in men's, ladies' medium and ladies' small. The shield is available in several colors including black, brown, grey, red, blue.

Price: $249. Yes, I know, it's steep, especially when you factor in the cost of prescription lenses, but it's not more than a pair of prescription Panoptx. Bear in mind that there are very high costs associated with developing this kind of product. In my opinion, moisture chambers are an important investment for chronic dry eye patients, and while I can't tell you which will be best for you, this one definitely deserves consideration.

p.s. No, that's not me in the picture... I stole the pic from the website.