Conjunctivitis drug reviewed by FDA

The FDA has accepted for review a New Drug Application for Bepreve (bepotastine ophthalmic solution; ISTA Pharmaceuticals) for the treatment of ocular itching associated with allergic conjunctivitis.

Bepreve is a selective histamine (H1) receptor antagonist, which inhibits the migration of eosinophils into inflamed tissue. The Phase III study achieved its primary endpoint: a statistically significant and rapid reduction in ocular itching and other symptoms associated with ocular allergic reactions. No significant adverse events were noted during trials.

ISTA anticipates that Bepreve will be approved in September 2009.