ISTA Pharmaceuticals Announces New Phase III Clinical Findings to Support Bepreve ...( Company Will Seek Label for the Treat...),Health

Company Will Seek Label for the Treatment of Ocular Itching Associated with

Allergic Conjunctivitis

IRVINE, Calif., April 30 /PRNewswire-FirstCall/ -- ISTA Pharmaceuticals, Inc. (Nasdaq: ISTA), today announced positive results from the preliminary analysis of its second and final Bepreve(TM) (bepotastine ophthalmic solution) Phase III clinical study. The U.S. multi-center conjunctival allergen challenge (CAC) study evaluated the onset and duration of effect of two Bepreve concentrations in 130 patients with a history of ocular allergies. Both concentrations demonstrated highly statistically significant reductions in the primary study endpoint of ocular itching. In addition, both concentrations produced highly statistically significant effects on the rapidity of response and in the secondary endpoints measuring additional signs and symptoms of ocular allergy, as well as improvement in total nasal symptoms. There were no serious ocular adverse events reported in patients dosed with Bepreve.

The Phase III study was a multi-center, double-masked, placebo-controlled study. It was designed to evaluate the onset and duration of effect of Bepreve in two concentrations and in two dosing schedules, once-daily and twice-daily. Of the 130 patients enrolled, 117 completed the study. Patients were randomized 1:1:1 to receive one of two concentrations of Bepreve. They were evaluated on 3 separate visits for their response to the dose administered, which would allow for the determination of the time to onset, response at 8 hours and at 16 hours. Both statistical significance and degree of clinical response, were measured. The strongest clinical effect achieved was with twice-daily dosing of either concentration. Furt
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