May 10 2013
InSite Vision Incorporated (OTCBB: INSV) today announced that patient enrollment has begun in the confirmatory Phase 3 clinical trial of BromSite™ (ISV-303) for the reduction of inflammation and pain 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.
“We anticipate top-line results from this Phase 3 study will be available in late 2013 or early 2014. Assuming positive results, we plan to file a New Drug Application with the FDA in 2014.”
"Our BromSite clinical program has been advancing rapidly and we expect that to continue with this Phase 3 trial, which is identical in design to our prior successful Phase 3 study. In our first Phase 3 study, all patients completed the trial in less than six months and we were able to release top-line results in less than eight months, start to finish," said Kamran Hosseini, M.D., Ph.D., Vice President and Chief Medical Officer of InSite Vision. "We anticipate top-line results from this Phase 3 study will be available in late 2013 or early 2014. Assuming positive results, we plan to file a New Drug Application with the FDA in 2014."
The first BromSite Phase 3 clinical trial enrolled 268 patients undergoing cataract surgery. On March 18, 2013, InSite announced that the primary endpoint of reduction of inflammation after surgery had achieved statistically significant superiority compared to vehicle (p<0.001). A secondary endpoint, reduction of pain, had also achieved statistically significant superiority to vehicle (p<0.001).
InSite Vision Incorporated