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ISTA Pharmaceuticals (ISTA) Announces Phase III Results for Once-Daily Topical Xibrom(TM) 0.09%

December 4, 2008 4:31 PM EST
ISTA Pharmaceuticals, Inc. (Nasdaq: ISTA) announced results from the Company's recently completed Phase III clinical program of Xibrom(TM) (0.09% bromfenac sodium ophthalmic solution) QD (once-daily). The program enrolled 282 patients who underwent cataract surgery in two U.S. multi-center, randomized, double-masked, parallel-group, vehicle-controlled studies to evaluate Xibrom 0.09% dosed once daily to vehicle (placebo). The identical trials were performed under a common protocol and designated the East region trial (ER) and the West region trial (WR).

According to a preliminary analysis, integrated results for the two studies demonstrated Xibrom 0.09% QD achieved statistical significance in meeting the primary efficacy endpoint of absence of ocular inflammation 15 days following surgery. In addition, Xibrom 0.09% QD met the secondary efficacy endpoint of elimination of ocular pain one day post surgery.

ISTA Pharmaceuticals is an ophthalmic pharmaceutical company.
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