InSite Vision has begun patient enrolment in the first Phase 3 clinical trial of BromSite (ISV-303) to reduce 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.
InSite Vision vice president and chief medical officer Kamran Hosseini said BromSite has the potential to significantly improve care for patients undergoing cataract surgery in the rapidly growing eye surgery market.
"We are confident this Phase 3 study will enrol 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," Hosseini added.
"We anticipate top-line results from this first Phase 3 study will be available in late 2012 or early 2013."
The double-blind, placebo-controlled study will enrol approximately 240 patients undergoing cataract surgery in a two-arm trial designed to assess the efficacy and safety of BromSite against the DuraSite vehicle alone.
Using 15 separate sites, patients undergoing cataract surgery will be randomised and then dosed twice-a-day beginning the day before surgery and continuing the day of surgery and 14 days post-surgery, according to the company.
The reduction of pain and inflammation after surgery is the primary endpoint of the study which will be managed by Pharm-Olam International as the contract research organisation on behalf of InSite Vision.