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.
"Cataract surgery is the most frequently performed ocular surgery in the U.S. and we believe there is significant opportunity to improve patient care following these procedures," said Kamran Hosseini, M.D., Ph.D., Vice President and Chief Medical Officer of InSite Vision. "Prior clinical trials of BromSite demonstrated superiority over the then market-leader, with twice the tissue penetration using a lower dose of bromfenac due to its formulation in our proprietary DuraSite vehicle. Better tissue penetration should reduce inflammatory symptoms, which are key to preventing post-surgical side effects, in addition to providing longer lasting pain relief to patients."
InSite reported results in March 2011, from a Phase 1/2 clinical study of 169 patients undergoing cataract surgery, in which once-daily and twice-daily doses of BromSite were compared against the DuraSite vehicle alone. Once-a-day BromSite was demonstrated to be superior to vehicle (53.3% versus 19.0%, P-value of 0.0016) in reducing pain and inflammation. In a Phase 2 clinical study evaluating pharmacokinetics, BromSite achieved more than twice the eye tissue penetration than Bromday™ (bromfenac ophthalmic solution) 0.09% marketed by ISTA Pharmaceuticals. Results from the Phase 2 clinical trial comparing BromSite to Bromday were released in October 2011.
InSite Vision Incorporated