The Dry Eye Zone

Rebecca's Blog

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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.
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