ISTA Pharmaceuticals, Inc. (Nasdaq: ISTA) announced poster presentations of results from the Company's Bepreve(TM) (bepotastine besilate ophthalmic solution) 1.5% Phase 3 clinical studies in allergic conjunctivitis. The studies demonstrated Bepreve was safe and well-tolerated when given twice daily for six weeks in a healthy pediatric population as young as three years of age. The clinical findings were presented at the American College of Clinical Pharmacy (ACCP) 2009 Annual Meeting in Anaheim, CA, and were encore presentations from earlier meetings in 2009.
In a poster previously presented at the American Academy of Allergy Asthma & Immunology 2009 Annual Meeting titled, "The Ocular Comfort and Safety of the Novel Anti-Histamine Bepotastine Besilate Ophthalmic Solution 1.5% in a Healthy Pediatric Population", ISTA presented results from a 6-week, multi-center, randomized, double-masked, placebo-controlled, parallel-group safety study. The study enrolled 861 individuals, of whom approximately 15% (127 subjects) were pediatric subjects. Subjects were randomized to receive either Bepreve or placebo twice daily. Following test drop instillation for each eye at study visit 2 (one week of dosing) and visit 3 (three weeks of dosing), the overall comfort of the investigational product was graded using a quantitative scale. The study showed there was no clinically or statistically significant difference in the ocular comfort of Bepreve and placebo among pediatric subjects, either immediately after or five minutes following instillation.
In a separate poster previously presented at the Association for Research in Vision and Ophthalmology 2009 Annual Meeting titled, "The Safety of the Anti-Histamine Bepotastine Besilate Ophthalmic Solution in a Healthy Pediatric Population from Ten to Seventeen Years of Age", ISTA presented subpopulation data from the 6-week, placebo-controlled, parallel-group safety study. The proportion of pediatric subjects in this age group instilling Bepreve and with an adverse event (22.5%) was similar to that seen for subjects 10-17 years of age instilling placebo (20.0%).
No severe adverse events were reported during the 6-week safety trial and all pediatric patients completed the trial.
In addition, ISTA presented additional efficacy results from placebo-controlled conjunctival allergen challenge (CAC) clinical trials with Bepreve 1.0% and 1.5%. The positive results for some non-ocular symptoms considered secondary endpoints in the CAC trials were presented in the following encore poster presentations:
Bepotastine Besilate Ophthalmic Solution Reduces Nasal Symptoms in the Conjunctival Allergan Challenge (CAC) Clinical Model
Authors: G.L. Torkildsen, P.J. Gomes, J.I. Williams, J.A. Gow, M.B. Abelson, T.R. McNamara
Bepotastine Besilate Ophthalmic Solution 1% Reduces Ear or Palate Pruritus with Rapid Onset in a Clinical Model of Allergic Conjunctivitis
Authors: G.L. Torkildsen, P.J. Gomes, J.I. Williams, J.A. Gow, M.B. Abelson, T.R. McNamara
Bepotastine Besilate Ophthalmic Solution 1% Reduces Ear or Palate Pruritus with Rapid Onset in a Clinical Model of Allergic Conjunctivitis
Authors: G.L. Torkildsen, P.J. Gomes, J.I. Williams, J.A. Gow, M.B. Abelson, T.R. McNamara
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.
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®. 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.
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.
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
View drug information on Bepreve; Bromfenac.