Thursday, June 1, 2006

Drug Pipeline

Phase III Clinicals (or thereabouts)

OTSUKA-NOVARTIS/REBAMIPIDE: Phase III clinical trials ongoing. This still seems to be the furthest along of anything in the current pipeline, though we're hearing rumors of, er, 'issues' from current or former study sites. And we've heard some modestly positive reports. Click here for initial screening checklist and list of study centers.

NOVAGALI/NOVA22007: Cyclosporine emulsion. Recently started Phase III clinicals after obtaining new funding. Click here for most recent press release.

NASCENT/ iDESTRIN (NP50301): 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: 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 Click here for most recent press release and here for ISTA's main (albeit very outdated) page on this.

Phase II clinicals

NOVARTIS / PIMECROLIMUS (AMS981): Recruiting for Phase II clinicals. Click here for more info (or patients interested in signing up click here).

LANTIBIO/MOLI1901: 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. What is it? Cystic fibrosis drug being attempted as a dry eye treatment.

Somewhere in limbo

ALLERGAN/ANDROGEN TEARS: Hellloooo, anybody out there? Last we heard something was supposed to be presented at ARVO. Was it? Does anybody know anything? Some Phase IIs had been completed. We are anxious to see this drug on the market. Why has everything come to a standstill since Allergan took it on? Anybody with intelligence about developments please let us know.

INSPIRE/"PROLACRIA" (DIQUAFOSOL TETRASODIUM): We flipped a coin and decided they'd opt for DNR in late April but we were apparently wrong. They now have a name for the product, if nothing else. We haven't seen anything really fresh about their FDA 'discussions'. Click here for Inspire's inspiring pages about it.

On the horizon

CAN-FITE/BIOPHARMA/CF-101: 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: 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.

SENJU/LACRITIN: 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.

PAI-2: 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.


ALCON/15-HETE: Mucin secretagogue. We never actually read an official 'dead in the water' notice anywhere so we've been kindly keeping this on the roster in hopes its resuscitation or death would become easier to confirm. Nothing came to our attention so this is the last time we will list it.