Monday, ISTA Pharmaceuticals, Inc. (ISTA) announced it has received notification from the U.S. Food and Drug Administration or FDA that the Dermatologic and Ophthalmic Drugs Advisory Committee will review ISTA's New Drug Application or NDA for Bepreve on June 26.
Bepreve is an eye drop treatment for ocular itching associated with allergic conjunctivitis. The NDA filing includes data from ISTA's Phase III clinical studies with Bepreve. The Phase III studies demonstrated highly statistically significant reductions in the primary endpoints of ocular itching.
As bepotastine is a new chemical entity in the U.S., ISTA expected an Advisory Committee would be convened for Bepreve. ISTA continues to expect a standard review of ten months and has been given a Prescription Drug User Fee Action date of September 12.
For comments and feedback: editorial@rttnews.com