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

IRVINE, Calif., Dec. 4 /PRNewswire-FirstCall/ -- ISTA Pharmaceuticals, Inc. (Nasdaq: ISTA), an ophthalmic pharmaceutical company, today 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.

When considered independently, the WR trial showed statistical significance in both the primary and secondary efficacy endpoints. The ER exhibited strong trends in both the absence of ocular inflammation and pain but did not meet statistical significance for either. The rate of patients who discontinued due to lack of efficacy in the ER was six times greater than the WR trial and a previous clinical trial utilizing the same protocol and concentration. In addition, there was a 20 percentage-point higher placebo effect for the relief of pain in the ER compared with the WR results and with previous trial experience with bromfenac ophthalmic solution. Despite the unexpected results reported for the ER Phase III study, there were strong trends in favor of statistical efficacy.

In addition, both Phase III studi
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SOURCE ISTA Pharmaceuticals, Inc.
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