ISTA allergy drug heading in the right direction

ISTA Pharmaceuticals has released promising preliminary results of a Phase II/III clinical study of its treatment for allergic conjunctivitis, bepotastine.

The study evaluated two concentrations, each dosed once and twice daily. Primary endpoints included efficacy in treating ocular itching and redness. Preliminary results demonstrate that both concentrations were highly statistically significant in the reduction of ocular itching, when dosed twice a day and in one concentration when dosed once a day. Both concentrations and dosing regimens also demonstrated highly statistically significant differences in the rapidity of response and the improvement in total nasal symptoms versus placebo. Evaluation of the second primary endpoint, ocular redness, showed a trend towards clinical significance but did not achieve statistical significance.

ISTA now plans to complete analysis of the data and discuss the results with the FDA to determine whether any further clinical studies are required before submitting a New Drug Application.