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Bepreve

Generic name: bepotastine
Treatment for: Conjunctivitis, Allergic

Update: Bepreve Now FDA Approved - September 8, 2009

Dermatologic and Ophthalmic Drugs Advisory Committee Recommends Bepreve

Dermatologic and Ophthalmic Drugs Advisory Committee Unanimously Recommends Bepreve for the Treatment of Ocular Itching Associated with Allergic Conjunctivitis

IRVINE, Calif., June 26, 2009 /PRNewswire-FirstCall/ -- ISTA Pharmaceuticals, Inc. today announced the Dermatologic and Ophthalmic Drugs Advisory Committee appointed by the U.S. Food and Drug Administration (FDA) recommended the approval of Bepreve (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.

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 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.

ISTA Pharmaceuticals is an ophthalmic pharmaceutical company. ISTA's products and product candidates addressing the $5.1 billion U.S. prescription ophthalmic industry include therapies for inflammation, ocular pain, glaucoma, allergy, and dry eye. The Company currently markets three products and is developing a strong product pipeline to fuel future growth and market share, thereby continuing its growth to become the leading niche ophthalmic pharmaceutical company in the U.S.

Any statements contained in this press release that refer to future events or other non-historical matters are forward-looking statements. Without limiting the foregoing, but by way of example, statements contained in this press release related to ISTA's expectation of becoming the leading niche ophthalmic pharmaceutical company are forward-looking statements. Except as required by law, ISTA disclaims any intent or obligation to update any forward-looking statements. These forward-looking statements are based on ISTA's expectations as of the date of this press release and are subject to risks and uncertainties that could cause actual results to differ materially. Important factors that could cause actual results to differ from current expectations include, among others, delays and uncertainties related to the FDA or other regulatory agency approval or actions; uncertainties and risks regarding market acceptance of and demand for ISTA's approved products; and such other risks and uncertainties as detailed from time to time in ISTA's public filings with the U.S. Securities and Exchange Commission, including but not limited to ISTA's Annual Report on Form 10-K for the year ended December 31, 2008, and its most recent Quarterly Report on Form 10-Q for the quarter ended March 31, 2009.

Posted: June 2009

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