InSite Vision, FDA discuss probable NDA for ocular anti-infective

InSite Vision representatives said they met recently with FDA officials to discuss sections of the proposed new drug application (NDA) submission for AzaSite, InSite's ocular anti-infective product. The drug is currently in late-stage development for the treatment of bacterial conjunctivitis.

The company said it anticipates launching AzaSite commercially in the United States in the second half of 2006, pending successful completion of and satisfactory results from current ongoing phase III clinical trials and subsequent filing of the full NDA and approval from the FDA.