ISTA Pharmaceuticals, Inc. announced the Company filed a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for Bepreve(TM) (bepotastine ophthalmic solution).
The Company is seeking approval for Bepreve as an eye drop treatment for ocular itching associated with allergic conjunctivitis. ISTA filed the Bepreve NDA electronically, in eCTD format and using the FDA's Electronic Submission Gateway.
Pending FDA validation of the electronic file in the coming days and timely acceptance of the filing by the FDA, ISTA expects a standard review of ten months from date of receipt.
In April of this year, ISTA announced highly statistically significant reductions in the primary study endpoint of ocular itching from the preliminary analysis of its second and final Bepreve Phase III clinical study. In addition, the results showed Bepreve had a statistically significant effect on the rapidity of response and in certain secondary endpoints measuring additional signs or symptoms of ocular allergy, including improvement in nasal symptoms. There were no serious ocular adverse events reported in patients dosed with Bepreve from the study.