MIAMI, Nov. 9 /PRNewswire-FirstCall/ -- ISTA Pharmaceuticals, Inc. (Nasdaq: ISTA), today announced additional results from the Company's Bepreve(TM) (bepotastine besilate ophthalmic solution) 1.5% Phase 3 clinical studies. These results were presented in poster sessions at the 2009 Annual Meeting of the American College of Allergy, Asthma & Immunology (ACAAI) in Miami Beach, FL.
In a poster presentation titled, "Treatment of Ocular Itching with Bepotastine Besilate Ophthalmic Solution 1.5% for Subjects with More Severe Itching Response in a Conjunctival Allergen Challenge (CAC) Clinical Model of Allergic Conjunctivitis," integrated results from two Phase 3 studies demonstrated Bepreve 1.5% was as effective in suppressing ocular itching in patients with more severe itching as in patients with all grades of ocular itching. A total of 157 patients were enrolled in two 7-week, masked, randomized, placebo-controlled CAC clinical studies (1 single site, 1 multi-site). 113 patients exhibited bilateral ocular itching grades greater than or equal to 3 at screening during study visit 2. Individuals were assessed at 15 minutes, 8 hours, or 16 hours following instillation at study visits spaced 2 weeks apart during the enrollment period. The difference in mean itching grades (placebo-active) for the more severely affected subjects was within plus or minus 0.1 unit of the differences for the entire intent-to-treat (ITT) population. Authors of the poster were J. I. Williams, J. A. Gow, P. J. Gomes, M. B. Abelson, and T. R. McNamara.
ISTA presented more results from CAC clinical trials with Bepreve 1.0% and 1.5% in the following poster presentations at the same meeting:
Bepotastine Besilate Ophthalmic Solution 1.5% Reduces Nasal Congestion with Rapid Onset in a Clinical Model of Allergic Conjunctivitis
Authors: G. L. Torkildsen, J. I. Williams, J. A. Gow, P. J. Gomes, T. R. McNamara
The Conjunctival Allergen Challenge (CAC) Model of Allergic Conjunctivitis - Does Assumption of a Normal Data Distribution Influence the Means for Evaluating Clinical and Statistical Significance?
Authors: K. S. Kennedy, J. I. Williams, J. A. Gow, M. B. Abelson, T. R. McNamara
Abstracts are published in the November issue of Annals of Allergy, Asthma & Immunology and are available online at www.annallergy.org.
About Bepreve(TM) (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 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(TM) is available on ISTA Pharmaceuticals' website at http://www.istavision.com/pdf/Bepreve_insert.pdf.
About ISTA Pharmaceuticals
ISTA Pharmaceuticals is the fourth largest branded ophthalmic pharmaceutical business in the U.S. ISTA's four marketed products plus its product candidates include therapies for inflammation, ocular pain, glaucoma, allergy, and dry eye. The Company is developing a strong product pipeline to fuel future growth and market share, 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.
Bepreve(TM) (bepotastine besilate ophthalmic solution) 1.5%, Xibrom(TM) (bromfenac ophthalmic solution) 0.09%, and Istalol® (timolol maleate ophthalmic solution) 0.5% are trademarks of ISTA Pharmaceuticals.
SOURCE ISTA Pharmaceuticals, Inc.
|SOURCE ISTA Pharmaceuticals, Inc.|
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