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.
"We are very pleased with the rapid enrollment of the Phase 3 BromSite study. Begun in August, our team has surpassed expectations for accrual and we now look forward to announcing top-line data for the Phase 3 clinical trial of BromSite early next year," said Timothy Ruane, Chief Executive Officer of InSite Vision. "We are finalizing our plans for a second Phase 3 clinical study of BromSite and, pending positive results from both trials, are committed to filing a New Drug Application for BromSite in 2013."
This is the first of two Phase 3 clinical studies in support of BromSite's regulatory submissions. In the second quarter of 2012, InSite conducted an end-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) and two European regulatory meetings, where both BromSite pivotal trials were discussed. InSite is finalizing the design of the second Phase 3 study for BromSite pending full input from the regulatory agencies.