ALAMEDA, Calif.--(BUSINESS WIRE)--InSite Vision Incorporated (OTCBB:INSV) today announced that the Company recently received eight minor recommendations regarding its proposed agreement with the U.S. Food and Drug Administration (FDA) under its Special Protocol Assessment (SPA) process for the design of InSite’s Phase 3 clinical trial of AzaSite Plus™ (ISV-502) and DexaSite™ (ISV-305) in patients with blepharitis, a chronic ophthalmic inflammatory condition that affects up to 34 million people in the United States. The Company filed its responses today accepting all recommendations from the FDA. An SPA is a written agreement with the FDA that the study design and planned analysis of the sponsor’s Phase 3 clinical trial adequately addresses the objectives necessary to support a regulatory submission.
