ISTA Pharmaceuticals Announces Statistically SignificantPreliminary Results From its U.S. Phase II/III Clinical Study OfBepotastine
IRVINE, Calif., May 08, 2007 /PRNewswire-FirstCall/ -- ISTA Pharmaceuticals, Inc., 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.
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.
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.
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 prospects and timing of further development of bepotastine, the potential of bepotastine of treating allergic conjunctivitis and of providing allergy sufferers with comprehensive protection for the treatment of their ophthalmic and nasal symptoms, the potential of bepotastine, if approved by the FDA, to quickly become a favorite amongst physicians and their patients suffering from allergic conjunctivitis and ISTA's goals of bringing a new product to market every 12 to 18 months and becoming the leading niche ophthalmic pharmaceutical company in the U.S. are forward-looking statements. Except as expressly 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 from current expectations. Important factors that could cause actual results to differ from current expectations include, among others: the risk that full analysis of the Phase II/III data, or further testing of bepotastine, will not reflect the preliminary Phase II/III results reported in this press release; delays, risks, and uncertainties related to ISTA's product development activities (including the difficulty of predicting the timing or outcome of bepotastine development efforts, clinical testing or studies, or FDA or other regulatory agency approval or actions); uncertainties and risks regarding market acceptance of ISTA's approved products and the impact of competitive products and pricing; risks and uncertainties related to successful compliance with FDA and/or other governmental regulations applicable to ISTA's facilities, products, and/or business; uncertainties and risks related to the scope, validity, and enforceability of patents related to ISTA's products and technologies and the impact of patents and other intellectual property rights held by third parties, and such 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, 2006 and its Quarterly Report on Form 10-Q for the quarter ended March 31, 2007.
Posted: May 2007