ISTA Pharmaceuticals Announces New Phase III Clinical Findings To Support Bepreve NDA Filing
ISTA Pharmaceuticals, Inc. (Nasdaq: ISTA), announced positive results from the preliminary analysis of its second and final Bepreve(TM) (bepotastine ophthalmic solution) Phase III clinical study. The U.S. multi-center conjunctival allergen challenge (CAC) study evaluated the onset and duration of effect of two Bepreve concentrations in 130 patients with a history of ocular allergies. Both concentrations demonstrated highly statistically significant reductions in the primary study endpoint of ocular itching. In addition, both concentrations produced highly statistically significant effects on the rapidity of response and in the secondary endpoints measuring additional signs and symptoms of ocular allergy, as well as improvement in total nasal symptoms. There were no serious ocular adverse events reported in patients dosed with Bepreve.
The Phase III study was a multi-center, double-masked, placebo-controlled study. It was designed to evaluate the onset and duration of effect of Bepreve in two concentrations and in two dosing schedules, once-daily and twice-daily. Of the 130 patients enrolled, 117 completed the study. Patients were randomized 1:1:1 to receive one of two concentrations of Bepreve. They were evaluated on 3 separate visits for their response to the dose administered, which would allow for the determination of the time to onset, response at 8 hours and at 16 hours. Both statistical significance and degree of clinical response, were measured. The strongest clinical effect achieved was with twice-daily dosing of either concentration. Further, the higher concentration of Bepreve demonstrated a once-daily clinical effect that was comparable to the published literature for FDA-approved once-daily ophthalmic solutions studied in patients with ocular allergies.
The data announced today mirror the results from the 107-patient, single- center Phase III Bepreve study, announced May 8, 2007, which used the same study design. ISTA currently is analyzing the results of an ocular safety study in approximately 850 patients, with preliminary results anticipated before the end of the second quarter of 2008. Once the Company completes its analysis of the full dataset, ISTA expects to file a New Drug Application (NDA) with the FDA during the second half of 2008. ISTA plans to discuss the study results with the FDA to determine what, if any, additional information would be required in order to obtain approval for both a once-daily and twice- daily form of Bepreve.
About Bepreve(TM) (bepotastine ophthalmic solution)
Bepreve 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.
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 from Senju the exclusive North American rights 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.
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 bringing a new product to market every 12 to 18 months, completing the preliminary analysis of the data from the Bepreve ocular safety study in the second quarter of 2008, filing the Bepreve NDA with the FDA in the second half of 2008, 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: timely and successful implementation of ISTA's strategic initiatives; delays and uncertainties related to ISTA's research and development programs (including the difficulty of predicting the timing or outcome of product development efforts and the FDA or other regulatory agency approval or actions); uncertainties and risks regarding market acceptance of and demand for ISTA's approved products and the impact of competitive products and pricing; uncertainties and risks related to ISTA's ability to properly manage its growth; uncertainties and risks regarding the continued timely performance by ISTA's strategic partners of their respective obligations under existing collaborations and licensing arrangements; uncertainties and risks related to the continued availability of third party sourced products and raw materials on commercially reasonable terms, or at all; uncertainties and risks 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 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.