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Insite Vision announces enrollment for phase 3 trial

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Patient enrollment has begun in the confirmatory phase 3 clinical trial of BromSite for the reduction of inflammation and pain after cataract surgery, according to an Insite Vision press release.

BromSite combines a low dose (0.075%) of the nonsteroidal anti-inflammatory drug bromfenac with InSite Vision’s DuraSite drug delivery technology, according to the release.

This study will seek to enroll approximately 240 patients undergoing cataract surgery in a two-arm trial designed to evaluate the efficacy and safety of BromSite against the DuraSite vehicle alone, the release said.

Top-line results are anticipated to be available in late 2013 or early 2014, and, assuming positive results, Insite Vision plans to file a New Drug Application with the U.S. Food and Drug Administration in 2014, according to the release.