Ophthalmologic products provider, InSite Vision has started the patient enrollment for the first Phase 3 clinical trial of BromSite (ISV-303), which is used to reduce pain and inflammation post cataract surgery.
The study will enroll nearly 240 cataract surgery patients in a two-arm trial, which is designed to evaluate the efficacy and safety of BromSite against the DuraSite vehicle alone.
As part of the clinical trial, patients will be randomized and will be dosed twice-a-day before the surgery day, on the day of surgery and 14 days post-surgery.
Pharm-Olam will serve as the contract research organization, managing the BromSite study on behalf of InSite Vision.
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 improve care for patients undergoing cataract surgery in the rapidly growing eye surgery market.
"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,"Hosseini added.
