Ista Pharmaceuticals has 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 versus 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.
Ista 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 a new drug application for bepotastine for the treatment of allergic conjunctivitis.
Bepotastine has three primary mechanisms of action, according to Ista: it is a non-sedating, highly selective antagonist of the histamine 1 receptor; it has a stabilizing effect on mast cells; and it suppresses the migration of eosinophils into inflamed tissues. The drug has been approved in Japan for use as a systemic drug in the treatment of allergic rhinitis and urticaria/pruritus.