InSite Vision commences enrollment in BromSite Phase 3 clinical trial

InSite Vision IncorporatedJul 31 2012

InSite Vision Incorporated (OTCBB: INSV) today announced that patient enrollment has begun in the first Phase 3 clinical trial of BromSite^™ (ISV-303) for the reduction of pain and inflammation after cataract surgery. This study will seek to enroll approximately 240 patients undergoing cataract surgery in a two-arm trial designed to evaluate the efficacy and safety of BromSite against the DuraSite vehicle alone. BromSite combines a low dose (0.075%) of the non-steroidal anti-inflammatory drug (NSAID) bromfenac with InSite Vision's DuraSite drug delivery technology.

"BromSite has the potential to significantly improve care for patients undergoing cataract surgery in the rapidly growing eye surgery market," said Kamran Hosseini, M.D., Ph.D., Vice President and Chief Medical Officer of InSite Vision. "We are confident this Phase 3 study will enroll quickly given the positive data obtained in our prior clinical trials of BromSite, including the statistically significant reduction in pain and inflammation achieved in our Phase 1/2 study with the same primary endpoint as this trial. We anticipate top-line results from this first Phase 3 study will be available in late 2012 or early 2013."