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ISTA Pharmaceuticals Announces Positive Preliminary Phase 3 Clinical Results to Support sNDA Filing for Once-Daily Xibrom(TM) 0.09%
Date:8/25/2009

IRVINE, Calif., Aug. 25 /PRNewswire-FirstCall/ -- ISTA Pharmaceuticals, Inc. (Nasdaq: ISTA), today announced positive preliminary Phase 3 results from the Company's Xibrom((TM)) (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, randomized, double-masked, parallel-group study in 299 patients who underwent cataract surgery in one eye. Patients were assigned randomly (1:1) to receive either Xibrom once daily or placebo. Dosing began one day before cataract surgery and continued for 14 days following surgery. The proportion of patients experiencing no pain was assessed at Day 1 post surgery, and the proportion of patients with complete absence of ocular inflammation was assessed at Day 15 post surgery. Ocular inflammation was evaluated using a summed ocular inflammation score (SOIS) and was measured by an assessment of immune cells in the anterior chamber of the eye ("cells") and cellular debris ("flare"). The secondary efficacy endpoint was evaluated via a pain score from the Ocular Comfort Grading Assessment recorded in a diary. Patients also graded their symptoms at each office visit, which included photophobia, the chief symptomatic complaint following cataract surgery.

In December 2008, ISTA announced integrated results from two Phase 3 studies with Xibrom 0.09% QD. Based on th
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SOURCE ISTA Pharmaceuticals, Inc.
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