Clinical Trials of Dry Eye Drugs
Click here for the FDA's list of actively recruiting dry eye clinical trials.
Updated January, 2012
Phase III clinical trials
NOVAGALI/CYCLOKAT: Jan 5 2011 press release indicated positive results from Phase III trial completed last year. According to April 5th press release, recruiting now for a pivotal European Phase III study.
EYEGATE PHARMA /
EGP-437: Clinicaltrials.gov indicates this drug's phase III trial was completed as of April 26, 2011. Awaiting results announcement. This is a drug/device combo, a corticosteroid delivered
by the EyeGate® II Delivery System. In addition a study appeared online recently though it doesn't seem to be available via PubMed yet (as of May 31st).
ISTA / REMURA: Disappointing results announced October 2011 from Remura EAST study. Ista is shifting focus to developing it as an OTC. What more appropriate graveyard could there be for a drug that fails to outperform placebo.
CAN-FITE BIOPHARMA / CF-101: Oral A(3) adenosine receptor agonist. Purchased by Denali Concrete Management in November 2011 and announced enrollment for Phase III trial in December.
SARCODE / SAR1118: Antiinflammatory. Started enrolling for Phase III trial in September, 2011.
ALLERGAN: Clinicaltrials.gov lists "EDNP" i.e. "eye drop new platform" in Phase III (being compared to Refresh) - and since the primary endpoint being evaluated is symptoms (OSDI) this is probably an OTC but that isn't quite clear. Allergan's site lists Restasis X in Phase II but no recent information on that at all.
The following are in or post Phase II, somewhere or other!
SEIKAGAKU: SI-614. First heard of this in a news report on 1/23/12. Hyaluronate product just starting Phase II in US.
ALCON: (1) DUREZOL: According to clinicaltrials.gov, Durezol is in a Phase II looking at its use specifically as an anti-inflammatory in dry eye patients. (2) ESBA105 (from acquisition of ESBATech in 2009), a biological, for severe dry eye, was added to clinicaltrials.gov in April 2011. (3) AL38583 (cyclosporine .05% or .10%) completed a Phase II last year but there hasn't been a peep out of it since then. Dark horse or dead in the water? Your guess is better than mine.
/ RX-10045 No news. Anti-inflammatory agent RX-10045 from Resolvyx successfully completed Phase I/II in 2009. Resolvyx's pipeline page now indicates that they are expecting to commence Phase III in the first half of 2011. In January 2011 Celtic Therapeutics exercised its option to acquire rights to and license this drug.
MIMETOGAN / MIM-D3 Positive Phase II data announced July 2011. Click here for news report. Another medical study was published in June 2011 as well.
SANTEN / DE110: Added to list May 2011 based on clinicaltrials.gov listing. Not sure what this is.
REGENERX / RGN259: Phase II for dry eye completed Oct 2011. Results reported in November indicated they failed to meet either of their target endpoints but did find enough significant sign/symptom improvements to continue studying the drug. A further report on the results was released in January.
INSPIRE / AZASITE (for blepharitis indication): No particular news. Various clinical trials including this one listed presently. Thea Pharma is running a trial for Azyter as well.
OTSUKA-ACUCELA/REBAMIPIDE: Otsuka has applied for regulatory approval in Japan following positive Phase III data, but is supposedly somewhere in Phase II in the US. Have not heard any positive noises about US prospects on this drug for a long time. Most recent press release here.
Status undetermined: stuck in a loop, dead or alive, dark horse? We don't really know:
BAUSCH & LOMB / BOL-303242-X (Mapracorat)
LANTIBIO / LANCOVUTIDE (formerly MOLI1901)
ALLERGAN / ANDROGEN TEARS
ALCON A last note on ex GSK Cilomilast and/or AL43546 - I don't know what's going on with these if anything but I will drop these from the roster if no news of resuscitation is forthcoming.
ALACRITY / ALTY0501
PFIZER / Tofacitinib
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