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ISTA Pharmaceuticals Announces Statistically Significant,Preliminary Results From its U.S. Phase II/III Clinical Study Of,Bepotastine

IRVINE, Calif., May 08, 2007 /PRNewswire-FirstCall/ -- ISTA Pharmaceuticals, Inc., today announced results from the preliminary analysis of its U.S. Phase II/III clinical study of bepotastine for the treatment of allergic conjunctivitis. The study evaluated two concentrations of bepotastine, each dosed once daily and twice daily. The primary endpoints of the study were the assessment of efficacy for bepotastine in treating ocular itching and redness. The preliminary results of the study demonstrate both concentrations were highly statistically significant in the reduction of the first primary endpoint, ocular itching, when dosed twice a day, and in one concentration when dosed once a day. In addition, both concentrations and dosing regimens produced highly statistically significant differences in the rapidity of response and the improvement in total nasal symptoms vs. placebo. In the preliminary evaluation of the second primary endpoint, ocular redness, bepotastine showed a trend toward clinical significance, but did not achieve statistical significance. Several ocular allergy products have been approved by the FDA based on Phase III clinical data demonstrating the achievement of statistical significance and clinical success for one of the primary endpoints, ocular itching or redness.

ISTA plans to complete the Phase II/III study analysis and then discuss the results with the Food and Drug Administration to determine the remaining clinical studies required to confirm ocular safety and efficacy for the submission of an NDA for bepotastine for the treatment of allergic conjunctivitis.

"Bepotastine's multiple mechanisms of action have the potential to provide allergy sufferers with comprehensive protection for the treatment of their ophthalmic and nasal symptoms. We are impressed with the convenient dosing schedule, the rapid onset of action, and clinical efficacy bepotastine exhibited in this study,
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