InSite Vision (ISV) Fully Enrolls Phase 3 Clinical Study of BromSite for the Reduction of Pain and Inflammation after Cataract Surgery
11/29/2012 9:36:42 AM
ALAMEDA, Calif.--(BUSINESS WIRE)--InSite Vision Incorporated (OTCBB: INSV) today announced that patient enrollment has been completed in the first Phase 3 clinical trial of BromSite™ (ISV-303) for the reduction of pain and inflammation after cataract surgery. BromSite combines a low dose (0.075%) of the non-steroidal anti-inflammatory drug (NSAID) bromfenac with InSite Vision’s DuraSite® drug delivery technology. This study enrolled more than 240 patients undergoing cataract surgery in a two-arm trial designed to evaluate the efficacy and safety of BromSite against the DuraSite vehicle alone. At 15 separate sites, patients were randomized and then dosed twice-a-day beginning the day before surgery and continuing the day of surgery and 14 days post-surgery. The primary study endpoint is the reduction of pain and inflammation after surgery. Currently, about 80 patients remain on-study. InSite Vision expects that the Phase 3 BromSite clinical trial will be complete and top-line data available in early 2013.