ISTA Pharmaceuticals, Inc. (ISTA) presented results from one of two Phase 3 studies of PROLENSA (bromfenac ophthalmic solution), the company's once-daily topical nonsteroidal anti-inflammatory product candidate for the treatment of ocular inflammation and pain following cataract surgery.
According to the company, the findings showed PROLENSA was statistically greater than placebo in clearing subjects' ocular inflammation by day 15 and eliminating ocular pain one day post-surgery, the study's primary and secondary endpoints, respectively.
ISTA Pharma noted that it plans to file a New Drug Application with the U.S. Food and Drug Administration, or FDA, for PROLENSA in the first half of 2012.
Also, additional data from the poster presentation, titled "Phase III Clinical Trial of Low Concentration Bromfenac Ophthalmic Solution Dosed Once Daily for Postoperative Ocular Inflammation and Pain", showed there were no serious drug-related ocular or systemic adverse events, and PROLENSA's safety profile was consistent with the company's currently marketed once-daily topical nonsteroidal anti-inflammatory compound, BROMDAY (bromfenac ophthalmic solution) 0.09%.
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