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ISTA Pharmaceuticals Announces New Phase III Clinical Findings to Support Bepreve NDA Filing
Date:4/30/2008

her, the higher concentration of Bepreve demonstrated a once-daily clinical effect that was comparable to the published literature for FDA-approved once-daily ophthalmic solutions studied in patients with ocular allergies.

The data announced today mirror the results from the 107-patient, single- center Phase III Bepreve study, announced May 8, 2007, which used the same study design. ISTA currently is analyzing the results of an ocular safety study in approximately 850 patients, with preliminary results anticipated before the end of the second quarter of 2008. Once the Company completes its analysis of the full dataset, ISTA expects to file a New Drug Application (NDA) with the FDA during the second half of 2008. ISTA plans to discuss the study results with the FDA to determine what, if any, additional information would be required in order to obtain approval for both a once-daily and twice- daily form of Bepreve.

About Bepreve(TM) (bepotastine ophthalmic solution)

Bepreve has three primary mechanisms of action: it is a non-sedating, highly selective antagonist of the histamine 1 (H1) receptor, it has a stabilizing effect on mast cells, and it suppresses the migration of eosinophils into inflamed tissues. The compound's primary mechanisms of action are believed to make it an effective treatment against the signs and symptoms of allergic conjunctivitis.

Bepotastine was approved in Japan for use as a systemic drug in the treatment of allergic rhinitis and urticaria/pruritus in July 2000 and January 2002, respectively, and is marketed by Mitsubishi Tanabe Pharma Corporation (formerly Tanabe Seiyaku Co., Ltd.) under the brand name TALION(R). TALION was co-developed by Tanabe Seiyaku and Ube Industries, Ltd., who discovered bepotastine. In 2001, Tanabe Seiyaku granted Senju Pharmaceutical Co., Ltd., exclusive worldwide rights, with the exception of certain Asian countries, to develop, manufacture, and market bepotastine for ophthalmic use. In 2
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SOURCE ISTA Pharmaceuticals, Inc.
Copyright©2008 PR Newswire.
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