ISTA Pharmaceuticals presents additional data from its Bepreve Phase 3 clinical studies

Nov 9 2009

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.