InSite Vision Meets With The FDA On Pre-NDA Discussions For AzaSite(TM)

ALAMEDA, Calif.--(BUSINESS WIRE)--April 27, 2006--InSite Vision Incorporated (AMEX:ISV - News) -- an ophthalmic therapeutics, diagnostics and drug-delivery company -- today announced that it had a pre-NDA meeting with representatives of the U.S. Food and Drug Administration (FDA) on Wednesday, April 26, 2006. The purpose of the meeting was to discuss the proposed new drug application (NDA) submission for AzaSite(TM), the Company's ocular anti-infective product. InSite recently announced the successful completion of the second of two required Phase 3 clinical trials to evaluate the safety and efficacy of AzaSite. In this study, patients treated with AzaSite had a significantly higher clinical resolution rate, the trial's primary efficacy end point, and a significantly higher bacterial eradication rate, a secondary end point, than those receiving a placebo. The study showed that AzaSite was safe and well tolerated.