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Bepreve

Generic name: bepotastine
Treatment for: Conjunctivitis, Allergic

Update: Bepreve Now FDA Approved - September 8, 2009

NDA Filed for Bepreve

ISTA Pharmaceuticals Files New Drug Application with U.S. FDA for Bepreve

IRVINE, Calif., November 13, 2008 /PRNewswire-FirstCall/ -- ISTA Pharmaceuticals, Inc. , today announced the Company filed a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for Bepreve (bepotastine ophthalmic solution). The Company is seeking approval for Bepreve as an eye drop treatment for ocular itching associated with allergic conjunctivitis.

ISTA filed the Bepreve NDA electronically, in eCTD format and using the FDA's Electronic Submission Gateway. Pending FDA validation of the electronic file in the coming days and timely acceptance of the filing by the FDA, ISTA expects a standard review of ten months from date of receipt.

In April of this year, ISTA announced highly statistically significant reductions in the primary study endpoint of ocular itching from the preliminary analysis of its second and final Bepreve Phase III clinical study. In addition, the results showed Bepreve had a statistically significant effect on the rapidity of response and in certain secondary endpoints measuring 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 from the study.

About Bepreve (bepotastine ophthalmic solution)

Assuming both timely acceptance by the FDA of the Bepreve NDA for filing and approval to market, Bepreve would participate in the U.S. ocular allergy market, which had estimated 2007 sales of approximately $560 million based on data from IMS Health. Assuming approval, Bepreve would participate in ISTA's largest market to date, as compared to ISTA's currently marketed products.

Bepreve has three primary mechanisms of action: it 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 into and activation of eosinophils in 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.

About ISTA Pharmaceuticals

ISTA Pharmaceuticals is an ophthalmic pharmaceutical company. ISTA's products and product candidates addressing the $4.7 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. The Company's product development and commercialization strategy is to launch a new product every 12 to 18 months, 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 the FDA's timely acceptance and approval of Bepreve, ISTA's belief that the FDA will review and take action on Bepreve within ten months of filing, ISTA's expectation of bringing a new product to market every 12 to 18 months and 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, 2007, and its most recent Quarterly Report on Form 10-Q for the quarter ended September 30, 2008.

Posted: November 2008

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