Jul 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."
InSite Vision Incorporated