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ISTA Pharmaceuticals' Bepreve(TM) Receives FDA Approval for the Treatment of Ocular Itching Due to Allergies
Date:9/8/2009

IRVINE, Calif., Sept. 8 /PRNewswire-FirstCall/ -- ISTA Pharmaceuticals, Inc. (Nasdaq: ISTA) today announced the U.S. Food and Drug Administration (FDA) has approved Bepreve(TM) (bepotastine besilate ophthalmic solution) 1.5% as a twice-daily prescription eye drop treatment for ocular itching associated with allergic conjunctivitis in patients two years of age and older.

"Bepreve offers a new, safe and effective way to treat the itching caused by ocular allergies. We expect to have Bepreve available to ophthalmologists and patients in the United States in the fourth quarter of 2009," stated Vicente Anido, Jr., Ph.D., President and Chief Executive Officer of ISTA. "Because of the timing of this approval and the strength of our underlying business, we will accelerate all of the launch activities immediately, including the scale-up of the sales force. This will allow us not only to finish this year very strongly but also enter next year with an expanded sales force in place. Bepreve and Xibrom will share the top spot on our promotional activities, but we will continue to devote time and energy to Istalol, too."

ISTA conducted multiple clinical studies, evaluating the safety, efficacy, onset and duration of effect of Bepreve. Two Phase 3 double-masked, placebo-controlled, conjunctival allergen challenge (CAC) studies demonstrated Bepreve significantly reduced ocular itching. In addition, the studies achieved statistical significance and demonstrated Bepreve's rapid onset of action in providing relief to persons with ocular itching associated with allergic conjunctivitis.

"Patients who experience ocular itching due to allergies want comfortable, quick and long-lasting relief for their eyes. Bepreve is the first truly new treatment for allergic co
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SOURCE ISTA Pharmaceuticals, Inc.
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