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Dermatologic and Ophthalmic Drugs Advisory Committee Unanimously Recommends Bepreve(TM) for the Treatment of Ocular Itching Associated with Allergic Conjunctivitis
Date:6/26/2009

IRVINE, Calif., June 26 /PRNewswire-FirstCall/ -- ISTA Pharmaceuticals, Inc. (Nasdaq: ISTA) today announced the Dermatologic and Ophthalmic Drugs Advisory Committee appointed by the U.S. Food and Drug Administration (FDA) recommended the approval of Bepreve(TM) (bepotastine besilate ophthalmic solution) 1.5% as an eye drop treatment for ocular itching associated with allergic conjunctivitis. The Committee voted unanimously 7 to 0 in favor of approving Bepreve after reviewing comprehensive safety and efficacy data from ISTA's clinical program.

"The Committee's vote supports our belief that Bepreve provides a safe and effective treatment for ocular itching associated with allergic conjunctivitis. We will continue to work closely with the FDA as we approach the September 12th action date," stated Vicente Anido Jr., Ph.D., President and Chief Executive Officer of ISTA Pharmaceuticals.

Although the FDA is not required to follow the Committee's guidance, the Agency usually considers the Committee's recommendation when evaluating pending applications. The FDA has assigned a Prescription Drug User Fee Action Date of September 12, 2009.

About Bepreve (bepotastine besilate ophthalmic solution) 1.5%

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 ocular itching associated with 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 Tana
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SOURCE ISTA Pharmaceuticals, Inc.
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