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ISTA Pharmaceuticals Reports Positive Preliminary Results from its Phase 1/2 Clinical Study of Bepotastine Besilate Nasal Spray for the Treatment of Symptoms Associated with Seasonal Allergic Rhinitis
Date:10/6/2010

triggers, Mountain Cedar pollen.  Assuming timely filing of the IND application and timely commencement and completion of the Phase 2 studies, we expect to report preliminary Phase 2 data from the Mountain Cedar pollen study during the first half of 2011."

About the Phase 1/2 Bepotastine Besilate Nasal Spray Clinical Study And Results

The Phase 1/2 study was a double-masked, randomized, placebo-controlled, parallel-group study evaluating the safety and efficacy of three concentrations of bepotastine besilate, dosed twice daily, in an Environmental Exposure Chamber (EEC) treatment model for allergic rhinitis.  Following initial screening, 82 patients (males and females, aged 18 – 65 years) were exposed on multiple occasions in the EEC to a high aerosol concentration of a common seasonal allergen to which they were sensitive. The patients graded their individual symptoms at select time intervals prior to and following a single dose or one week of dosing with bepotastine besilate nasal spray or placebo. In addition, pharmacokinetic (PK) data on the three concentrations of bepotastine besilate nasal spray were assessed based on blood draws from a subset of patients.  Reported allergy symptoms included both nasal symptoms and ocular symptoms. Safety was evaluated based on several variables, including adverse events, physical and nasal examinations, vital signs, electrocardiograms, and the mean grades for questions on a brief satisfaction and tolerability questionnaire completed at the end of the study.

This clinical study showed the highest two concentrations of bepotatine besilate nasal spray tested provided both statistically significant and clinically meaningful improvement compared to placebo in reducing total nasal symptoms. This was true in reports from patients for both instantaneous and reflective experiences of their total nasal symptoms. Statistically significant improvements also were seen for all individual
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SOURCE ISTA Pharmaceuticals, Inc.
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