InSite Vision announced top-line results from its Phase 3 clinical trial of BromSite (ISV-303) for the reduction of inflammation and pain after cataract surgery. BromSite is a combination of low dose (0.075%) bromfenac, a non-steroidal anti-inflammatory drug (NSAID) with InSite Vision’s DuraSite drug delivery technology.
The confirmatory BromSite Phase 3 clinical trial enrolled 248 patients undergoing cataract surgery in a two-arm trial designed to evaluate the efficacy and safety of BromSite against the DuraSite vehicle alone. Patients were randomized and then dosed twice-a-day beginning the day before surgery and continuing the day of surgery and for 14 days post-surgery.
BromSite achieved statistically significant superiority compared to vehicle (P=0.01) in alleviating ocular inflammation as measured by the absence of cells in the anterior chamber of the eye at Day 15 among patients following cataract surgery compared to the vehicle arm.
InSite plans to file the NDA for BromSite’s regulatory approval during the second half of 2014.
For more information call (510) 865-5700 or visit InSiteVision.com.