ISTA Pharmaceuticals Initiates Clinical Development of Bepotastine Besilate Nasal Spray for the Treatment of Symptoms Associated with Seasonal Allergic Rhinitis
IRVINE, Calif., July 14 /PRNewswire-FirstCall/ — ISTA Pharmaceuticals, Inc. (Nasdaq: ISTA), today announced it has initiated a Phase 1/2 clinical study of bepotastine besilate nasal spray for the treatment of symptoms associated with seasonal allergic rhinitis, the inflammation of the nasal passages caused by allergies. The randomized, placebo-controlled, parallel-group study will evaluate the safety and efficacy of three concentrations of bepotastine besilate, dosed twice daily, in an Environmental Exposure Chamber (EEC) model of allergic rhinitis caused by natural exposure to seasonal allergens. The study also will assess the pharmacokinetics (PK) of the investigational nasal sprays.
Following initial screening, 96 patients will be randomized into the Phase 1/2 clinical study. During the study, patients will be exposed to pollen in the EEC and will grade their individual symptoms at select time intervals prior to and following dosing with bepotastine besilate nasal spray or placebo. Reported symptoms will include both nasal symptoms and ocular symptoms. Safety will be evaluated based on several variables, including adverse events, electrocardiograms, and the mean grades for questions on a brief satisfaction and tolerability questionnaire completed at the end of the study. In addition, PK data on the three dose concentrations of bepotastine besilate nasal spray will be assessed based on blood draws from a subset of patients.
“This milestone attests to the continuing momentum of our programs addressing the allergy market,” stated Vicente Anido, Jr., Ph.D., President and Chief Executive Officer of ISTA. “Last year, we received FDA approval for BEPREVE, our eye drop treatment for itching associated with allergic conjunctivitis. We now are looking forward to potentially expanding our allergy franchise with a formulation that can treat nasal allergies.”
ISTA expects to complete the Phase 1/2 clinical study of bepotastine besilate nasal spray and announce preliminary results from the study in the fall of 2010.
About Allergic Rhinitis
According to the American Academy of Allergy Asthma & Immunology (AAAAI), approximately 60 million Americans are affected by allergic rhinitis, an inflammation of the nasal passages caused by exposure to certain allergens, such as pollen from trees, grass and plants, animal dander, feathers, dust mites and molds. Allergic rhinitis is characterized by a number of symptoms, including sneezing, nasal congestion, nasal itching and runny nose. The eyes, ears, sinuses, and throat also can be affected. Current treatments for allergic rhinitis include antihistamines, mast cell stabilizers, anti-inflammatories, and steroids. Based on data from IMS Health, approximately 43.3 million prescriptions were filled for nasal allergy treatments in 2009, resulting in sales of approximately $2.2 billion.
About bepotastine besilate
Bepotastine besilate 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 for nasal symptoms associated with allergic rhinitis.
Bepotastine besilate 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 TALIONÃ‚®. TALION was co-developed by Tanabe Seiyaku and Ube Industries, Ltd., who discovered bepotastine besilate. 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 besilate for ophthalmic use. In 2006, ISTA licensed the exclusive North American rights from Senju to an eye drop formulation of bepotastine besilate for the treatment of allergic conjunctivitis. In 2007, ISTA licensed exclusive North American rights to nasal dosage forms of bepotastine besilate from Tanabe Seiyaku and obtained a future right to negotiate for a North American license to oral dosage forms of bepotastine besilate for allergy treatment.
ISTA’s eye drop formulation of bepotastine besilate, BEPREVEÃ‚® (bepotastine besilate ophthalmic solution) 1.5%, was approved by the U.S. Food and Drug Administration (FDA) in September 2009 for the treatment of ocular itching associated with allergic conjunctivitis. ISTA’s nasal spray formulation for allergic rhinitis currently is in clinical studies and has not yet been approved by the FDA.
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, the Company generated 2009 revenues of $111 million. For additional information about ISTA Pharmaceuticals, please visit the corporate website at 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 the expected initiation and completion of the clinical studies for bepotastine besilate nasal spray and the announcement of results in the fall of 2010 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, delays and uncertainties related to the FDA or other regulatory agency approval or actions 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, 2009 and its Quarterly Report on Form 10-Q for the quarter ended March 31, 2010.
SOURCE ISTA Pharmaceuticals, Inc.