Ista reports mixed results for allergic conjunctivitis treatment

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.

Although 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 the preliminary evaluation of the second primary endpoint, ocular redness, bepotastine did not achieve statistical significance.

However, 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, the company said.

Ista said that it plans to complete the phase II/III study analysis and then discuss the results with the FDA 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.