InSite Vision has enrolled more than 240 patients for the first phase 3 clinical trial of BromSite (ISV-303) to reduce pain and inflammation after cataract surgery.
The study, which enrolled patients undergoing cataract surgery in a two-arm trial, will evaluate the efficacy and safety of BromSite against the DuraSite drug delivery technology.
InSite Vision chief executive officer Timothy Ruane said, "We are finalizing our plans for a second Phase 3 clinical study of BromSite and, pending positive results from both trials, are committed to filing a New Drug Application for BromSite in 2013."
The study forms part of first two phase 3 clinical studies in support of BromSite’s regulatory submissions.
InSite Vision vice president and chief medical officer Kamran Hosseini said, "Better tissue penetration should reduce inflammatory symptoms, which are key to preventing post-surgical side effects, in addition to providing longer lasting pain relief to patients."
BromSite found to be superior to DuraSite vehicle (53.3% versus 19.0%, P-value of 0.0016) in reducing pain and inflammation during the phase 1/2 clinical study conducted in March 2011.