Thursday, February 28, 2008

Drug news: The latest on Prolacria

Excerpt from Inspire's February 26th investor call below. Bottom line, they're now enrolling patients for a pilot study and have given a little more information on what they'll be studying. For those who don't have a context for this, Prolacria (diquafosol tetrasodium) failed FDA approval 3 times and Inspire opted in 2007 to go back and do more clinical trials. For patience and persistence, we've really got to hand it to them.

In 2007, we made progress in our dry eye program by identifying a reasonable path forward to potentially obtain regulatory approval of Prolacria. As we’ve previously indicated, based on analysis of our existing clinical data and input from dry eye experts as well as several meetings held with the FDA, we are now focusing our efforts on evaluating the effects of Prolacria on the central region of the cornea as measured by fluorescein staining scores.

Today, we want to let you know that we are now actively enrolling patients in a pilot trial studying Prolacria and ORA’s proprietary dry eye model. The purpose of this trial is to confirm an appropriate clinical trial designed to be used for a potential pivotal Phase III clinical trial. If the data from the pilot study is favorable, we plan to move this program forward aggressively. Based on current plans in the program, we are on track to provide you with an update on our progress and potential next steps for the third quarter of 2008.

Today, we are also pleased to provide you with an update regarding the development of this dry eye product in Japan. Our Asian partner, Santen Pharmaceuticals, a premier ophthalmology company in Asia, has made significant progress in their Phase III program over the past year. Santen has now publicly stated that they plan to file an application for marketing approval with regulators in Japan in the July to September timeframe this year. We will be eligible to receive a modest cash milestone payment upon completion of the Phase II testing and we will receive royalties in Japan as well as non-other Asian countries that the product is ultimately approved. In Japan, alone, there is an estimated 8 million dry-eye sufferers, so it is a large market there as well. Santen has extensive experience in this market and we are encouraged by the progress in the development of the product in Japan.

Tuesday, February 26, 2008

Rebecca's journal: Scleral update

Well, time for a quick update on my scleral lenses, or, as I've on occasion heard them rather mockingly referred to, my hubcaps.

As many of you know, I went back to Boston Foundation for Sight in October to tune up my left eye, since the first time around I had not given them anything like enough time to really optimize the vision. I came away ecstatic because the improvement to my left (non-dominant) eye was such that I could then see with both eyes better than I had ever done since my LASIK back in 2001.

My vision continues to be excellent. This is the first winter in 6 years that I've been able to drive at night.

Not that I do a lot of that, especially when I've been neglecting my eyes as I too often do. It's been so long that I just am not in the habit of going out much after dark anyway. But one thing I've enjoyed is every Wednesday night taking my daughter to AWANA (a church program for kids that Chaidie absolutely loves), which meets about half an hour away from our home. Last year my brother and his wife, whose kids attend the same program, were very kind about ferrying her there and back, but it's so nice to be able to get involved myself and not have to worry about transportation. I would say my vision is not trouble-free at night. IF I could remember to refill my lenses before heading out, I think that I'd see much like I reported shortly after the trip to BFS, but I don't, so I compensate by dumping NutraTear on my lenses when I get in the car.

Driving in the dark AND rain is another matter. I always hated that, even back in my glasses and contact lenses days. But at least it doesn't mean I'll get stranded anymore. I can manage, and that makes such a difference to me.

As regards comfort: Doing very well. It's been kind of a rough winter; it was colder and snowier here than usual, and we're currently living in a place with forced air heat. When the heat's on I am noticeably less comfortable in the evenings after a long workday but still plenty manageable, that is, I can just tune it out. I'll occasionally refill the lenses in the evening if I need to.

Other stuff... Funnily enough, after nearly two years in these lenses I recently went through a rough patch of having difficulty getting my right lens in in the morning! I simply could not get it to clear my lid fully and would get really frustrated. I don't know what the explanation is but I suspect that it's lid inflammation that's just not obvious to me in the mirror. Whatever the cause, I've had to go back to basics and instead of just plunking the lenses in by feel, I have to be much more careful in my technique, and make sure my hands and lids are quite dry etc. It's improved a lot in the last few days.

So that's where I'm at. Still very much the BSL happy camper and ever so grateful for this treatment modality, without which I would be unable to work full time, drive, or be pain-free during the day. Go BFS!

As for you non-believing MDs out there, you need to get with the times and learn more about BSLs and which of your most distressed patients might be able to benefit from them. If you want to know what the lenses are like or anything at all about my experience, why I'm wearing sclerals in the first place, etc, don't hesitate to call. 1-877-693-7939 x2 (physicians line).


Monday, February 25, 2008

UK News: 3 OTC drops available from Altacor/Clinitas

Altacor is distributing 3 OTC products in the UK under the "Clinitas" label

1) Clinitas Hydrate
Carbomer 98 0.2%. Sounds like Viscotears in a tube?

2) Clinitas Soothe
Sodium hyaluronate 0.4% (a la Vismed?)

3) Clinitas Ultra 3
PVA, Povidone, & Amisol Clear
(This is Freshkote under a UK label and in a 10mL bottle)

Here's a link for more information.

New drug news - nada

Here's my clinical trial roster:

Clinical trials of dry eye drugs

There's supposedly an awful lot going on out there, but nobody's press released anything recently and I haven't even heard any gossip (credible or otherwise). If I don't hear some news soon I might have to make some up and start my own little tabloid.

Yoo hoo, pharma-boys. Get a move on. Surely something's happening out there somewhere?

Rebecca's journal: Update on Barleans

I'm still going strong on Barleans cinnamon flavored flax oil. Every morning... bowl of yoghurt with 2T of this bright yellow stuff stirred into it and topped with berries. And I'm still tickled pink that I've finally got an effective way to trick my husband into getting some Omega 3s into his diet.

We're almost through our first bottle. I'll be temporarily switching to lemon at that point, basically just because I opened a bottle of lemon to see what it was like. It's more subtle than the cinnamon (though the cinnamon is quite gentle too) so even easier to 'hide'. I am toying with the idea of squirting some into a salad. Maybe.

My only other adventure so far: My daughter caught sight of one of the Barleans sample bottles of "Kids DHA" which has pictures of berries all over it. She wanted a taste. Wow, just what I need: a guinea pig! I've been trying to steel myself to try a little oil "straight up" (or "neat" as our over-the-pond members call it) and haven't gotten there yet. What I really want to know, of course, is, does it make your mouth feel all disgusting and oily? and how quick can you get rid of the taste?

So, I put a little bit on a spoon for my enthusiastic, unsuspecting 5-year-old. I figured, if she gags and runs for water, well, heck, there's no way I'M trying it. (Mind, this is one of those weird kids that actually adores whole grain bread, broccoli, lentils, feta cheese and all kinds of essentially unamerican things.)

Her reaction: Blank. "Mom... it really doesn't taste like anything." "Well, what does it feel like in your mouth?" "Nothing. Just nothing." Hallelujah. I took the spoon back and tried a couple of drops. Reaction: Pretty much the same. At least the fear factor's gone. I guess I'm ready to do the salad thing.

Spoonful, no way. Not yet.

Oh by the way, I have the flavored oils in the shop now. Except that I think Cinnamon is sold out, but I'll have more tomorrow. I am sooo glad these guys are based near me.

Study: REM sleep and tears...

This is kind of an interesting theory - basically that during REM sleep the reason we blink so much is to keep the eye surface wet.

REM Sleep: Tear Secretion and Dreams.
Murube J.
Ocul Surf. 2008 Jan;6(1):2-8.

ABSTRACT Although a number of hypotheses exist to explain the reasons for the rapid eye movement (REM) phase of sleep, the physical movements themselves have not been explained or interpreted in the literature. The author theorizes that REM during sleep serves not only to increase the lacrimal secretion and to humidify and lubricate the ocular surface, but also to redistribute the secretion on the ocular surface and to inform the conjunctiva-associated lymphoid tissue (CALT) system. He hypothesizes that when eyes move in REM periods to humidify the ocular surface, they indirectly release phenomena of the visual activity, producing dreams.

Study: Contacts and dry eye

(Sound of Rebecca salivating)

I definitely need a reprint of this one, especially coming from one of the leading dry eye researchers. The online blurb is simply too tantalizing. I'll report back when I've gotten and read the whole thing.

Contact lenses and associated anterior segment disorders: dry eye disease, blepharitis, and allergy.
Lemp MA, Bielory L.
Immunol Allergy Clin North Am. 2008 Feb;28(1):105-17.

This article discusses the use of contact lenses in patients suffering from dry eye and ocular allergy. The diagnosis of dry eye is outlined along with the relationship between contact lenses, the tear film, and the ocular surface. A practical approach to the recognition and management of the dry eye patient wishing to wear contact lenses is presented. In addition, a consideration of a careful strategy to identify patients with ocular allergy and manage the use of contact lenses in these patients is developed with an emphasis on the avoidance of complications.

Study: Diurnal tear meniscus variations

I put a technical title on the post as a signal that probably only the technically inclined will care.... It should go without saying, though, that the more we (speaking collectively) know about the features/behavior of a normal, healthy tear film, the better we can understand our tear film when it's diseased.

Diurnal Variation of Upper and Lower Tear Menisci.
Shen M, Wang J, Tao A, Chen Q, Lin S, Qu J, Lu F
School of Ophthalmology and Optometry, Wenzhou Medical College, Wenzhou, Zhejiang, China.

PURPOSE: To determine diurnal variation of tear menisci around upper and lower eyelids in normal subjects. DESIGN: Prospective laboratory investigation. METHODS: Twenty young healthy Chinese subjects (10 women and 10 men; mean age, 21.3 years; range, 20 to 26 years) with no history of contact lens wear or previously diagnosed dry eye were recruited. A custom-built, real-time anterior segment optical coherence tomography (OCT) instrument was used simultaneously to image the upper and lower tear menisci. Repeated measurements immediately after blinking were conducted on both eyes during a 24-hour period, including immediately before and after sleeping. Dimensional information of the tear menisci were obtained from the OCT images using custom software. RESULTS: There were no significant differences between right and left menisci, nor were there any differences between females and males in the lower tear meniscus (P > .05, repeated-measurement analysis of variance [ANOVA]). Although the lower tear meniscus variables were correlated strongly with upper meniscus variables, the lower meniscus was significantly greater than the upper one. Significant diurnal variations (P < .05, repeated-measurement ANOVA) of all measured variables were observed during the study period. Tear menisci were significantly increased at eye opening after overnight sleep compared with the baseline before sleep at 10 PM (P < .001, post hoc tests). They remained elevated up to 10 minutes after eye opening (P < .001, post hoc tests). CONCLUSIONS: Real-time OCT can provide useful information regarding the dynamics of the tear system. Diurnal variation of the upper and lower tear menisci occur.

Study: PCOS and MG function

Another little clue in the hormone/dry eye mystery series. Those of you who are following the hormonal research may want to jot down the authors' names and see what else they've got. When I looked at the cross-references I was surprised to see that there was another study on PCOS and dry eye published in AJO last year that I'd missed. Unlike the study below, it showed INCREASED goblet cell density (hmmmmm). Here's a link to last year's study.

Meibomian Gland Alterations in Polycystic Ovary Syndrome.
Yavas GF, Ozturk F, Kusbecı T, Ermıs SS, Yılmazer M, Cevrıoglu S, Aktepe F, Kose S.
Curr Eye Res. 2008 Feb;33(2):133-138

Purpose: Polycystic ovary syndrome (PCOS) is an endocrinopathy characterized by chronic anovulation and hyperandrogenism where hyperinsulinemia can be seen. Hormonal changes can affect meibomian gland function. In this study, we evaluated tear function in PCOS. Materials and Methods: Twenty-seven women having PCOS and 22 normal individuals aged between 18-42 years were enrolled in the study. Patients were asked about dry eye symptoms. Schirmer test, tear film breakup time, and rose Bengal staining were performed. Conjunctival brush cytology specimens were obtained and goblet cell count was done. Results: Dry eye symptoms were more frequent in subjects with PCOS (p = 0.025). Mean breakup time was shorter in women with PCOS (p = 0.034). Schirmer test results, rose Bengal staining scores, and goblet cell count were not different between groups (p = 0.48, p = 0.18, p = 0.82, respectively). Conclusion: Meibomian gland function and tear film lipid layer can be affected in cases with PCOS.