ISTA Pharmaceuticals Announces Statistically Significant Preliminary Results From Its U.S. Phase II/III Clinical Study Of Bepotastine

ISTA Pharmaceuticals, Inc.(Nasdaq: ISTA), today announced results from the preliminary analysis of its U.S. Phase II/III clinical study of bepotastine for the treatment of allergic conjunctivitis. The study evaluated two concentrations of bepotastine, each dosed once daily and twice daily. The primary endpoints of the study were the assessment of efficacy for bepotastine in treating ocular itching and redness. The preliminary results of the study demonstrate both concentrations were highly statistically significant in the reduction of the first primary endpoint, ocular itching, when dosed twice a day, and in one concentration when dosed once a day. In addition, both concentrations and dosing regimens produced highly statistically significant differences in the rapidity of response and the improvement in total nasal symptoms vs. placebo. In the preliminary evaluation of the second primary endpoint, ocular redness, bepotastine showed a trend toward clinical significance, but did not achieve statistical significance. Several ocular allergy products have been approved by the FDA based on Phase III clinical data demonstrating the achievement of statistical significance and clinical success for one of the primary endpoints, ocular itching or redness. ISTA plans to complete the Phase II/III study analysis and then discuss the results with the Food and Drug Administration to determine the remaining clinical studies required to confirm ocular safety and efficacy for the submission of an NDA for bepotastine for the treatment of allergic conjunctivitis. "Bepotastine's multiple mechanisms of action have the potential to provide allergy sufferers with comprehensive protection for the treatment of their ophthalmic and nasal symptoms. We are impressed with the convenient dosing schedule, the rapid onset of action, and clinical efficacy bepotastine exhibited in this study," stated Timothy R. McNamara, Pharm.D., ISTA's Vice President, Clinical Research and Medical Affairs. "Should bepotastine's performance in Phase III testing confirm the results we observed in the Phase II/III study, we believe this product, if approved, will have the potential of quickly becoming a favorite amongst physicians and their patients suffering from allergic conjunctivitis." In the Phase II/III study, there were no serious adverse events reported in patients dosed with bepotastine. Importantly, there were no reports of incidences of burning or stinging with either concentration and no reports of increases in ocular adverse events compared with placebo. ISTA will host a conference call with a simultaneous webcast today, May 8, 2007 at 10:30 AM Eastern Time to discuss today's announcement regarding the bepotastine Phase II/IIII study preliminary results and other recent product development announcements. About Bepotastine Bepotastine for the eye has three primary mechanisms of action: it is a non-sedating, highly selective antagonist of the histamine 1 (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. According to IMS, in 2006, the U.S. ocular allergic conjunctivitis market size was approximately $500 million. 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 Tanabe Seiyaku Co., Ltd. under the brand name TALION(R). TALION(R) 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 from Senju the exclusive North American rights to an eye drop formulation of bepotastine for the treatment of allergic conjunctivitis. About ISTA ISTA Pharmaceuticals is an ophthalmic pharmaceutical company. ISTA's products and product candidates addressing the $3.2 billion U.S. prescription ophthalmic industry include therapies for inflammation, ocular pain, glaucoma, allergy, dry eye, and vitreous hemorrhage. 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

(Author: http://www.istavision.com.

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