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news.The study enrolled 861 individuals, of whom approximately 15% were pediatric subjects
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ISTA Pharmaceuticals has announced poster presentations of results from its Bepreve (bepotastine besilate ophthalmic solution) 1.5% phase 3 clinical studies in allergic conjunctivitis. The studies demonstrated that 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. 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%).
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 American College of Clinical Pharmacy (ACCP) 2009 Annual Meeting.