Surgery
ISTA Pharmaceuticals Announces Positive Preliminary Phase 3 Clinical Results to Support sNDA Filing for Once-Daily Xibrom(TM) 0.09%
Published in Medical Devices and Surgical Technology Week, September 13th, 2009
ISTA Pharmaceuticals, Inc. (NASDAQ:ISTA), announced positive preliminary Phase 3 results from the Company's Xibrom™ (bromfenac ophthalmic solution) 0.09% QD (once-daily) confirmatory clinical study. Xibrom 0.09% QD achieved statistical significance in the study's primary endpoint, the absence of ocular inflammation 15 days following cataract surgery, and the secondary efficacy endpoint, the elimination of ocular pain one day post surgery. During the study, no serious ocular or systemic adverse events occurred, and the safety profile is consistent with ISTA's currently marketed Xibrom twice-daily formulation.
The confirmatory Phase 3 study was a multi-center,...
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