New drug application accepted for bepotastine

Irvine, CA

-ISTA Pharmaceuticals’ new drug application for bepotastine ophthalmic solution (Bepreve) has been accepted for review by the FDA, the company announced in a prepared statement. The company is seeking approval for the solution to be used as an eye drop treatment for ocular itching associated with allergic conjunctivitis.

Phase III clinical studies conducted with the solution showed highly statistically significant reductions in the primary endpoints of ocular itching. The results also showed that it had a statistically significant effect on the rapidity of response and the additional signs or symptoms of ocular allergy, including improvement in nasal symptoms. No serious ocular adverse events were reported in patients who received the drops.