IRVINE, CA--(Marketwire - March 22, 2011) - ISTA Pharmaceuticals, Inc. (NASDAQ: ISTA), today announced additional results from the Company's BEPREVE® (bepotastine besilate ophthalmic solution) 1.5% Phase 3 clinical studies in allergic conjunctivitis. These results were presented in poster sessions at the 2011 American Academy of Allergy, Asthma and Immunology (AAAAI) Annual Meeting in San Francisco, CA.
In a poster presentation titled "Bepotastine Besilate Ophthalmic Solution 1.5% Reduces Nonocular Composite Symptom (NOCS) Scores 16 Hours Following Dosing in the Conjunctival Allergen Challenge (CAC) Model of Allergic Conjunctivitis," the Phase 3 studies demonstrated BEPREVE was statistically superior to placebo in reducing summed NOCS scores up to 16 hours after ophthalmic dosing. The data shows support for the clinical effectiveness of BEPREVE in reducing nonocular symptoms associated with allergic conjunctivitis. Authors of the poster were J. I. Williams, T. T. Macejko, M.T. Bergmann, E. J. Meier, M. B. Abelson, J. A. Gow, and T. R. McNamara.
ISTA presented additional effectiveness results from the BEPREVE CAC clinical studies in the following poster presentations at the same meeting:
Bepotastine Besilate Ophthalmic Solution 1.5% Produces Strong Clinical Benefit for Ocular Itching Immediately Following Dosing in the Conjunctival Allergen Challenge (CAC) Model of Allergic Conjunctivitis
Authors: J. C. Clark, J. I. Williams, P. J. Gomes, M. B. Abelson, J. A. Gow, and T. R. McNamara
Bepotastine Besilate Ophthalmic Solution 1.5% Reduces Tearing 16 Hours Following Dosing in the Conjunctival Allergen Challenge (CAC) Model of Allergic Conjunctivitis
Authors: J. A. Gow, E. B. McLaurin, F. K. Kurata, M. B. Abelson, J. I. Williams, and T. R. McNamara
ABOUT BEPREVE® (BEPOTASTINE BESILATE OPHTHALMIC SOLUTION) 1.5%
BEPREVE 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 of eosinophils into inflamed tissues. The compound's primary mechanisms of action are believed to make it an effective treatment against ocular itching associated with allergic conjunctivitis.
BEPREVE was approved by the U.S. Food and Drug Administration in September 2009 for the treatment of ocular itching associated with allergic conjunctivitis. Bepotastine has been approved in Japan for systemic use in the treatment of allergic rhinitis since 2000 and urticaria/pruritus since 2002. It is marketed in Japan by Mitsubishi Tanabe Pharma Corporation (formerly Tanabe Seiyaku Co., Ltd.) under the brand name TALION®. 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. In 2007, ISTA licensed the exclusive North American rights to nasal dosage forms of bepotastine from Tanabe Seiyaku and obtained a future right to negotiate for a North American license to oral dosage forms of bepotastine for allergy treatment.
Full prescribing information for BEPREVE is available on ISTA's website at http://www.istavision.com/pdf/Bepreve_insert.pdf.
ABOUT ISTA PHARMACEUTICALS
ISTA Pharmaceuticals, Inc., is the fourth largest and fastest growing branded prescription eye care business in the United States, with an expanding focus on allergy therapeutics. ISTA currently markets four products, including treatments for ocular inflammation and pain post-cataract surgery, glaucoma and ocular itching associated with allergic conjunctivitis. The company's development pipeline contains additional candidates in various stages of development to treat dry eye, ocular inflammation and pain, and nasal allergies. Headquartered in Irvine, California, ISTA generated revenues of $156.5 million in 2010. For additional information about ISTA, please visit the corporate website at www.istavision.com.
BEPREVE® is a trademark of ISTA Pharmaceuticals, Inc. TALION® is a trademark of Mitsubishi Tanabe Pharma Corporation.