ISTA Pharma (ISTA) Reports Positive Results from Phase 3 Study of PROLENSA, to File New NDA in 1H'12
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ISTA Pharmaceuticals, Inc. (NASDAQ: ISTA) today 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. 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. These data were presented in a poster session at the 2012 American Society of Cataract and Refractive Surgery (ASCRS) Symposium and Congress being held from April 20 to 24, 2012, in Chicago, IL. The Company intends to file a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for PROLENSA in the first half of 2012.
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", demonstrated there were no serious drug-related ocular or systemic adverse events, and 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%.
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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", demonstrated there were no serious drug-related ocular or systemic adverse events, and 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%.
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