MAR 20, 2013
InSite Vision announced that its product, BromSite, performed significantly better compared to vehicle at alleviating ocular pain and inflammation after cataract surgery in a Phase 3 clinical trial.
BromSite combines a low dose (0.075%) of the non-steroidal anti-inflammatory drug bromfenac with the company's DuraSite drug delivery technology. This is the first of two Phase 3 clinical studies in support of BromSite's regulatory submissions.
"The results of our Phase 3 clinical study verify the efficacy of BromSite in providing relief of pain and inflammation after cataract surgery at a lower drug concentration than the current market leader and reinforce our earlier clinical findings," said Kamran Hosseini, MD, PhD, chief medical officer of InSite Vision. "We plan to rapidly initiate the second Phase 3 trial of BromSite in order to be prepared to file for regulatory approvals in both the United States and Europe as soon as possible after the completion of that trial."
The trial included 268 patients who underwent cataract surgery and were randomly divided into groups that received BromSite or the DuraSite vehicle alone. Patients were dosed twice daily from 1 day preop to 14 days postop.
BromSite achieved statistically significant superiority vs. the vehicle alone in reduction of inflammation (P < .001), which was the primary endpoint, and reduction in pain (P < .001), the secondary endpoint.
InSite's DuraSite and DuraSite 2 platforms are sustained delivery technologies using a synthetic polymer-based formulation designed to extend the residence time of a drug relative to conventional topical therapies. These platforms enable topical delivery of a solution, gel or suspension. They increase the duration of drug retention on the eye's surface, thereby reducing the frequency of treatment and improving the efficacy of topical drugs.