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Two Multi-Center Phase 3 Clinical Trials Initiated for Once-Daily Formulation of Bromfenac

IRVINE, Calif., May 30 /PRNewswire-FirstCall/ -- ISTA Pharmaceuticals, Inc. (NASDAQ:ISTA) announced today that the Company is initiating two randomized, double-blind, placebo-controlled multi-center Phase III clinical trials of a new proprietary once-daily formulation of Xibrom(TM) (bromfenac ophthalmic solution) for the treatment of pain and inflammation following cataract surgery. Twice-daily Xibrom(TM) has been approved by the U.S. Food and Drug Administration for the treatment of ocular inflammation and reduction of ocular pain following cataract surgery. The Xibrom(TM) once-daily Phase III clinical trials, which are expected to enroll approximately 350 patients under a common protocol, are designed to investigate the safety, tolerability and efficacy of once-daily Xibrom(TM) for the treatment of post-operative ocular pain and inflammation in subjects who have undergone cataract extraction with posterior chamber intraocular lens implantation. ISTA believes that the clinical trials will be concluded in the fourth quarter of this year with preliminary results available in early 2007. Assuming timely completion and successful results of the Phase III clinical studies, ISTA intends to file a supplemental New Drug Application for the once-daily formulation of Xibrom(TM) in 2007. "These Phase III studies of a once-daily formulation are a natural extension of ISTA's continued research with Xibrom," stated Vicente Anido, Jr., Ph.D., President and Chief Executive Officer of ISTA Pharmaceuticals. "The trials we are now initiating are designed to demonstrate that once-daily application of our new proprietary formulation of Xibrom can further reduce the number of daily doses, potentially improving compliance while maintaining effectiveness." ABOUT XIBROM(TM) AND THE U.S. OPHTHALMIC ANTI-INFLAMMATORY MARKET Xibrom(TM) (bromfenac ophthalmic solution) 0.09% is a sterile, topical, non-steroidal anti-inflammatory solution for the treatment of ocular inflammation and pain following cataract surgery. Senju Pharmaceuticals Co. Ltd. has marketed the twice-daily formulation of this product in Japan since 2000 with over 7.9 million uses since that time. ISTA acquired U.S. marketing rights for Xibrom(TM) in May 2002 under a license from Senju. ISTA has completed two pivotal Phase III clinical studies of the twice- daily formulation of Xibrom(TM) in the United States. In these studies involving 527 patients, a statistically significant proportion of patients treated with Xibrom(TM) achieved treatment success, defined as the complete absence of ocular inflammation compared to those patients who received placebo. This effect was evident in the Xibrom(TM) group as early as day 3 following initiation of treatment. Furthermore, 75% of patients were pain-free within two days of being treated with Xibrom(TM) twice daily. In addition, 93% of patients receiving Xibrom(TM) twice daily were pain-free within six days of treatment. The topical ophthalmic anti-inflammatory market consists of steroids, NSAIDs and combination products. Based upon 2005 prescription data from IMS, ISTA estimates that U.S. sales in 2005 in this market were approximately $400 million, with total prescriptions of 8.8 million. For additional information on Xibrom(TM), including full prescribing information, please visit https://www.bausch.com/en/ecp/our-products/rx-pharmaceuticals/rx-pharmaceuticals-ecp.

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