Tuesday, May 8, 2007

Newsclip: Cyclosporine + Methylprednisolone

Another soundbite from ARVO:

Adding Methylprednisolone to Cyclosporine in the Treatment of Sjogren's Syndrome

Adding methylprednisolone to cyclosporine appears to provide benefits for many patients with severe dry eye associated with Sjogren's syndrome, but the benefit is short lived and typically levels off within three months, a study presented here shows.

Pass. Wake me up when they find something that lasts and that works better than my rice bag.

New drugs update: Progesterone cream

Progesterone cream successfully treated dry eye in study

Dr. Connor evaluated tear breakup time, Schirmer's test results and IOP and administered the Ocular Surface Disease Index (OSDI) questionnaire to 30 patients to measure the effectiveness of the topical progesterone treatment. He found that tear breakup time significantly improved from 5.96 ± 2.18 seconds at baseline to 8 ± 3.5 seconds after 3 weeks of treatment with the cream. Schirmer's test results also improved after treatment, although not significantly, from 11.9 ± 6.87 mm at baseline to 14.175 ± 8.41 mm.

Newsclip: UK article on Sjogrens

This article in the Daily Mail caught my eye because of the dry eye title:

No tears to shed: The dry eye disease.

....But for Bridget, 52, and the other 500,000 sufferers of Sjogren's syndrome, an auto-immune disease, it can be years before diagnosis is made.

It is the UK's second most common autoimmune rheumatic disease.

But, according to Dr Elizabeth Price, a rheumatologist at the Great Western Hospital, Swindon, and an expert on the syndrome, the average time for diagnosis is ten years.

Dr Price says: "Many sufferers aren't taken seriously by their GPs, and those who are see consultants in a host of specialities, usually with no conclusions drawn, because the symptoms are so diverse...."

Pleased to see coverage for Sjogrens, and dry eye... I hope this can be followed up with more dry eye coverage in the UK press where it surely is needed!

New drugs update: Lantibio/Vismed(R)

Click here for press release

Lantibio and TRB Chemedica have initiated phase III clinicals of their sodium hyaluronate drop. This is available OTC in Europe but they are planning on filing an NDA for it in the US.

CHAPEL HILL, N.C., US and VOUVRY, VALAIS, Switzerland, Jan. 16 /PRNewswire/ -- Lantibio, Inc. and TRB Chemedica announced today the initiation of a Phase III clinical trial with VISMED(R) in dry eye syndrome. The corresponding protocol was negotiated with the FDA under the Special Protocol Assessment (SPA) program and consists of a multi-center, randomized, controlled and double-blinded study. VISMED(R) is a patented formulation containing sodium hyaluronate, currently marketed to millions of dry eye syndrome sufferers in Europe by TRB Chemedica. VISMED(R) is being studied in the US as a treatment for dry eye syndrome, under IND 73,441 filed in June 2006. The SPA was cleared by FDA in December of 2006 and the first patients were enrolled in the study immediately thereafter. If the current Phase III study is successful Lantibio expects to file a New Drug Application (NDA) for VISMED(R) in 2008.

New drugs update: Alacrity / topical doxy

Alacrity is supposed to be presenting its phase II clinical trial results at ARVO shortly. Stay tuned.... This is the doxycycline drop that has sounded somewhat promising.

Wall Street Journal article

The WSJ published an article about dry eye last week (May 1st).

I thought Rhonda Rundle did an awesome job:

She covered a wide range of causes, including elective surgeries such as laser eye surgery and cosmetic eyelid surgeries, where patients are frequently not informed ahead of time what their risks are (and often are not well screened for special risk factors).

She made it clear that dry eye is not just a minor nuisance but is actually debilitating for many people.

She mentioned many treatments and products above and beyond the usual fare of drops, plugs and Restasis.

If those three things don't sound earthshattering, then point me to any major article in any really influential media that has achieved even one of those three things. Having the weight of the WSJ behind statements like that is, in my opinion, really groundbreaking. It lends credibility to the disease that it has not often been accorded before, and opens the door for further follow up by other press.

Some highlights...

Inadequate attention
For some people, dry eye is more than a small irritation -- it can be a debilitating condition that causes painful scratchiness, light sensitivity and stinging in the eyes. But dry-eye patients say they often get perfunctory care from ophthalmologists and optometrists, who simply advise them to blink more and use over-the-counter lubricating drops. Such products may offer temporary relief, but they can be expensive, and many patients complain that they aren't very effective.

Laser surgery connection

nd many complaints are linked to the popularity of vision-correction surgery. There are about 1.4 million surgeries a year in the U.S., according to industry research firm Market Scope. Ophthalmologists say that dry eye is a common side effect that can become chronic in some patients....

Ironically, chronic dry eye can also be caused by patients' efforts to relieve contact-lens discomfort. Some patients who find they can't wear contacts turn to laser surgery. But such intolerance is a warning sign of a possibly higher risk of dry eye, ophthalmologists say. The condition is common after Lasik surgery, and usually goes away within a few months. But doctors say that for a small percentage of patients -- perhaps 5% -- dry eye can be a lasting and debilitating outcome....

Cathy Bishop-Clark, a professor of computer and information technology at Miami University's Middletown, Ohio, campus, says she tried "a boatload of treatments, including Restasis, which didn't help me." She says she gets help from special goggles meant to create a moisture chamber around the eyes. "I came across the goggles at a motorcycle shop," she says. She has five pairs, costing between $125 and $150 each.

Panoptx Eyewear, a closely held Pleasanton, Calif., company, developed the eyewear for skiers and other outdoor sports enthusiasts. A few years ago, the company started marketing to dry-eye patients.

Dr. Bishop-Clark, 43 years old, says her dry eye was caused by Lasik surgery seven years ago. She says she was told by her surgeon that dry eye was a risk, but a very low one. Because she can't stand to have her eyes open all the time, she has had to curtail her leisure reading and hire people to assist her at work. "Dry eye just sounds so trivial, but it's a disability," she says.

New drugs update: Argentis ARG101(T), ARG102(P)

I received an update from Argentis last week on their two hormone-type therapies in the pipeline. I think this is an interesting area and would like to better understand the potential applicability to chronic meibomian gland dysfunction, which seems to be the root of dry eye for many of us.

We now have in-licensed two therapies to treat dry eye syndrome (DES), ARG101(T) and ARG102(P) from the Southern College of Optometry (SCO). The patent for ARG101(T) was issued in December 2003. In December 2006, arGentis submitted a patent application for ARG102(P). Both therapies provide for transdermal delivery of the active pharmaceutical ingredient through application of a cream or gel formulation to the upper and lower eyelids, and a mechanism of action that restores the natural process of tear production.

ARG101(T) is a testosterone cream or gel formulation used to treat DES in menopausal women. Waning androgen levels in women before, during, and after menopause has been identified as a primary cause of DES. ARG101(T) is unique in that it is applied to the upper and lower eyelids for transdermal delivery of testosterone directly to the affected glands. Our research shows by delivering the active pharmaceutical ingredient transdermally allows better access to the glands and enables convenient twice-daily dosing. ARG101 (T) restores aqueous and lipid production thereby restoring the natural process of tear production.

ARG102(P) is a progesterone cream or gel formulation used to treat DES in men and younger women. The cross-reactivity between progesterone and corticosteroid receptors in the ocular region is believed to activate corticosteroid anti-inflammatory activity in the glands and on the ocular surface, restoring normal aqueous and lipid production. ARG102 (P) is also applied to the upper and lower eyelids for transdermal delivery of progesterone directly to the affected glands.

Although ARG101(T) and ARG102(P) have different active pharmaceutical ingredients and treat different populations of DES patients, they share several characteristics which make them unique among current DES therapies and those in development:

A patient-friendly application with a cream or gel formulation to the upper and lower eyelids versus conventional drop application.
Transdermal delivery of anti-inflammatory hormones directly to the affected glands.
Restores the natural process of tear production versus tear replacement of conventional therapies.
Convenient twice-daily dosing versus the frequent applications required by tear replacement therapies.
No stinging or burning of the skin to which it is applied or of the ocular surface.

Moving forward, arGentis intends to begin a Phase I/II trial in 2007 to confirm the results that have been achieved with their use in clinical practice at the Southern College of Optometry. We expect the trial to begin in Q4:07 with results available in Q1:08.

Here's a link
to their pipeline page for full details.

New drugs update: Novagali Pharma - Nova22007

On April 26th, Novagali announced that the FDA had granted their IND to go ahead with Phase III clinicals for Nova22007 for moderate to severe dry eye.

Nova22007 is a Cyclosporine A ophthalmic product intended to be used to treat patients suffering from moderate-to-severe Dry Eye Syndrome. Nova22007 is a proprietary cationic emulsion enabling an optimal penetration of Cyclosporine A in tissues of the eye surface that benefit from Novasorb® cationic emulsion technology features.

Click here for press release.

ASCRS 2007

I ran a small exhibit for The Dry Eye Shop at ASCRS in San Diego last weekend. It was a completely different experience this year than last. Thought I'd share some of the highlights.


The Teeny Bikini: This is totally darling. It's basically a snap-on fabric covering for the Tranquileyes goggle, that literally makes it look like a bikini top (as opposed to a goggle...). I think it will probably also extend the life of the foam liners on the goggle as well.

Tranquileyes "clear" (yet to be christened...) This is the most exciting thing coming down the pipeline right now... Eyewear that you can wear at a computer without looking like a geek!!! It's hard to describe. It's basically a flexible clear plastic sort of thing in front, with a soft fabric strap just like the sleep mask - but I'm told that it will also be offered with glasses-like earpieces. The front part fits closely to the eyes, and can optionally be lined with foam. This product will not be available till late summer and I was just looking at a prototype, so I don't have all the details, but it's supposed to be possible to wear it underneath glasses. I think what Suzanne's trying to do here is make computer eyewear HIP. I cannot wait for the final product....


This time last year no one seemed to have a clue that we NEED eyewear for dry eye. This year, I had three different companies come by and tell me about products they're working on, some of which had prototypes already available. One was a soft flexible rubber shield around glasses that reminds me of the Eaglevision 'moist eye moisture panel' but is opaque and nicer in some ways. However, it only comes with THEIR glasses - you can't fit it onto your own. Another company is working on some Panoptx-type things at a much lower pricepoint. Also, I came across a surgical eye guard - I suppose it's a high-end version of what I had to wear for a few nights after LASIK years ago - that I think could just be a decent cheap TRANSPARENT sleep mask for those who find Tranquileyes too expensive and/or want to be able to see when they wake up in the middle of the night.


This was my very first time exhibiting our non-eyedrop products at a medical meeting and I thoroughly enjoyed it because it gave me far more, and better, opportunities to talk to ophthalmologists and technicians about dry eye. In particular, I had The Rice Baggy on display which gave me a chance to get onto my favorite topic of meibomian gland dysfunction. The responses were SO varied... from the young fellow in the Bay area who described himself as a "squeezer" to several other visitors who gave me blank stares when I first started talking about warm compresses. I was encouraged that many visitors already advise their patients to use warm compresses, and also encouraged that many who don't are, I think, now seriously going to consider it.


Hot button for many of us with dry eye. At a refractive surgery conference, obviously the majority of the attendees do LASIK or are in a practice that does. I was kind of amused that many of them - especially high-end clinics in SoCal - are looking at offering Tranquileyes in their postop kits. I just hope they're also paying close attention to dry eye symptoms before lasik.

I met Dr. Craig Berger, who is running a service that stores information about your lasik procedure so that when the time comes for cataract or other surgery, it's available to you without trying to track down a laser clinic (which may have changed names... been bought out... entered chapter 11... or whatever) to get your records. I think this is a great idea and that it's a useful service.


I finally got a chance to meet Chuck Leiter (Leiter's pharmacy in San Jose). Always fascinated me, because their business is at such an interesting crossroads of information - they have a finger in most emerging dry eye technologies and so they have a good sense of what's working and what's not. In addition, they compound a lot of UNpreserved versions of topical ophthalmic drugs, so I picked up a list of what they can do.


Whoops - days are passing and I see I don't manage to get this finished (still trying to find the rest of my notes!) so I'll go ahead and post it so as to move on to some other things.