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ISTA Pharmaceuticals Announces Phase III Results for Once-Daily Topical Xibrom(TM) 0.09%
Date:12/4/2008

es showed highly statistically significant results in the proportion of subjects with no photophobia (light sensitivity) at every study visit post-cataract surgery. This is in concordance with previous clinical trials with Xibrom. The studies also showed no serious ocular or systemic adverse events, and the safety profile is consistent with ISTA's currently marketed Xibrom twice-daily formulation.

ISTA has discussed the data with the FDA and plans to perform a confirmatory Phase III trial that it expects to complete in 2009.

Study Design

According to the Phase III protocols, patients who were undergoing cataract surgery in one eye 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 on 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 of cataract surgery.

Xibrom(TM) (bromfenac ophthalmic solution)

Xibrom is a topical non-steroidal anti-inflammatory compound for the treatment of ocular inflammation and pain following cataract surgery. Xibrom, under a different trade name but identical formulation, was launched in Japan in 2000 by Senju Pharmaceuticals Co. Ltd. ISTA acquired U.S. marketing rights for Xibrom in 2002 and launched the
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SOURCE ISTA Pharmaceuticals, Inc.
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