ISTA Pharmaceuticals, Inc. (NASDAQ:ISTA), today announced the Company filed a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for Bepreve(TM) (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(TM) (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. For additional information regarding ISTA, please visit ISTA Pharmaceuticals' website at http://www.istavision.com/ [1].