(By Balaseshan) ISTA Pharmaceuticals Inc. (NASDAQ:ISTA) said it plans to file a New Drug Application (NDA) for Prolensa in the first half of 2012 after the late-stage studies met the efficacy endpoints.
Prolensa is being developed for the treatment of ocular inflammation and pain following cataract surgery.
The company presented results from the second of two Phase 3 studies of Prolensa, its once-daily topical nonsteroidal anti-inflammatory product candidate. These data were presented in a poster session at the 2012 Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting being held from May 6-10, in Fort Lauderdale, FL.
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The findings showed Prolensa met both the study's primary and secondary efficacy endpoints, producing statistically greater clearing of subjects' ocular inflammation by Day 15 and a greater proportion of subjects that were pain free at one day post-cataract surgery than placebo.
Additional data demonstrated that there were no serious drug-related ocular or systemic adverse events, and that Prolensa's safety profile was consistent with ISTA's currently marketed once-daily topical nonsteroidal anti-inflammatory (NSAID) compound, Bromday (bromfenac ophthalmic solution) 0.09%.
Last month, ISTA presented similar results from the company's first Phase 3 study in a poster session at the 2012 American Society of Cataract and Refractive Surgery (ASCRS) Symposium and Congress in Chicago, IL.
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Data from both studies were collected under a common protocol and conducted and analyzed as two independent studies in the U.S. Based on the results of the two Phase 3 studies, ISTA plans to file a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for Prolensa in the first half of 2012.
From 2005 until 2011, ISTA marketed Xibrom (bromfenac ophthalmic solution) 0.09% in the U.S. for twice-daily use for the treatment of postoperative inflammation and the reduction of ocular pain in patients who have undergone cataract surgery. In October of 2010, ISTA received FDA approval for once-daily Bromday and discontinued shipments of Xibrom in February 2011.
Bromday is currently the only once-daily treatment option in the $370 million U.S. ophthalmic nonsteroidal anti-inflammatory market. ISTA acquired the U.S. ophthalmic rights to bromfenac in May 2002 under a license from Senju Pharmaceuticals Co. Ltd.
A U.S. patent was issued to ISTA's licensor, Senju, for Prolensa, which expires in September 2025. Prolensa is an investigational drug and not yet available for commercial use.
ISTA stock remains unchanged from Wednesday's close of $9.07. The stock has been trading between $2.88 and $11.36 for the past 52 weeks.