New drug application filed for bepotastine ophthalmic solution

Irvine, CA-ISTA Pharmaceuticals has filed a new drug application (NDA) with the FDA for bepotastine ophthalmic solution (Bepreve). If approved, the solution would be used as an eye drop treatment for ocular itching associated with allergic conjunctivitis.

In April 2008, ISTA announced highly statistically significant reductions in the primary study endpoint of ocular itching from the preliminary analysis of its second and final phase III clinical study of the drop. No serious ocular adverse events were reported in patients dosed with the solution from the study.

The drop has three primary mechanisms of action: it is a non-sedating, highly selective antagonist of the histamine receptor, it has a stabilizing effect on mast cells, and it suppresses the migration into and activation of eosinophils in inflamed tissues. These mechanisms are believed to make it an effective treatment against the signs and symptoms of allergic conjunctivitis, according to the company.

The NDA was filed electronically, in electronic Common Technical Documents format and using the FDA’s Electronic Submission Gateway. Pending timely acceptance of the filing, ISTA expects a standard review of 10 months from date of receipt.