ISTA Pharmaceuticals, Inc. (Nasdaq: ISTA), presented results from the Company's Bepreve(TM) (bepotastine besilate ophthalmic solution) Phase 3 pivotal clinical studies using the Conjunctival Allergen Challenge (CAC) model of allergic conjunctivitis. The studies demonstrated Bepreve 1.5% was effective at reducing ocular itching for at least 8 hours after dosing, with high statistical significance for improvement in ocular itching compared to placebo for up to 16 hours after dosing. In addition, there was evidence that Bepreve 1.5% substantially reduces tearing caused by a conjunctival allergen challenge for at least 8 hours after dosing. In addition, ISTA demonstrated Bepreve 1.5%, dosed twice daily for six weeks, was safe with minimal adverse events in a healthy pediatric population from 10-17 years of age. Results were presented at the Association for Research in Vision and Ophthalmology (ARVO) 2009 Annual Meeting in Ft. Lauderdale, FL.
In the poster presentation titled "Bepotastine Besilate Ophthalmic Solution 1.5% Reduces Ocular Itching Following Dosing in the Conjunctival Allergen Challenge (CAC) Model of Acute Allergic Conjunctivitis", ISTA demonstrated positive results from two 7-week, masked, randomized, placebo-controlled CAC clinical studies (1 single site, 1 multi-site). The two studies enrolled a total of 157 patients in the placebo and Bepreve 1.5% treatment groups. The study showed Bepreve 1.5% dosed in both eyes was clinically effective in reducing ocular itching associated with allergic conjunctivitis in the CAC model for at least 8 hours after dosing and statistically superior to placebo in reducing ocular itching at CAC tests conducted 15 minutes, 8 hours, and 16 hours after dosing (P