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FDA Accepts New Drug Application for Bepotastine Ophthalmic Solution

IRVINE, Calif., Jan. 15 /PRNewswire-FirstCall/ -- ISTA Pharmaceuticals, Inc. (NASDAQ:ISTA) , today announced that ISTA's New Drug Application (NDA) for bepotastine ophthalmic solution (Bepreve) has been accepted for review by the U.S. Food and Drug Administration (FDA). The Company is seeking approval for Bepreve as an eye drop treatment for ocular itching associated with allergic conjunctivitis. The Company expects a standard review of ten months and has been given a user fee action date of September 12, 2009.

ISTA's Phase III clinical studies with Bepreve demonstrated highly statistically significant reductions in the primary endpoints of ocular itching. In addition, the results showed Bepreve had a statistically significant effect on the rapidity of response and on additional signs or symptoms of ocular allergy, including improvement in nasal symptoms. There were no serious ocular adverse events reported in patients dosed with Bepreve.

About Bepreve (bepotastine ophthalmic solution)
Assuming approval from the FDA, Bepreve would participate in ISTA's largest market to date. IMS Health estimates the U.S. ocular allergy market generated approximately $560 million in sales in 2007. Bepreve is a non-sedating, highly selective antagonist of the histamine (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 2006, ISTA licensed the exclusive North American rights from Senju to an eye drop formulation of bepotastine for the treatment of allergic conjunctivitis.

Source: ISTA Pharmaceuticals, Inc.

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