Positive Phase 3 Results for InSite Vision's BromSite
InSite Vision announced top-line results from a recently completed 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) and the company's DuraSite drug delivery technology.
The study randomized 268 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 dosed twice a day beginning the day before surgery and continuing the day of surgery and for 14 days post-surgery. The primary endpoint was the reduction of inflammation after surgery.
BromSite achieved statistically significant superiority compared to DuraSite vehicle in alleviating ocular pain and inflammation in patients following cataract surgery (P<0.001).
For more information call (510) 865-5700 or visit www.insitevision.com.