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InSite releases positive results for phase 3 trial of BromSite

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InSite Vision announced top-line results from its confirmatory phase 3 clinical trial of BromSite for the reduction of inflammation and pain after cataract surgery, according to a press release.

The study included 248 patients who underwent cataract surgery in a two-arm trial to evaluate the efficacy and safety of BromSite (bromfenac 0.075% with DuraSite drug delivery technology) against the DuraSite vehicle alone. Patients were randomized and dosed twice a day 1 day before surgery, the day of surgery and 14 days after surgery.

BromSite demonstrated a statistically significant superiority over the DuraSite vehicle alone in alleviating ocular inflammation (P = .01), reducing postsurgical pain (P < .001) and reducing inflammatory flare (P < .01), according to the release.

“In consultation with the FDA on our BromSite phase 3 program, we have modified the intent-to-treat population to include just data from those patients who underwent surgery, thereby more accurately gathering data that pertain to the postsurgical indication,” Kamran Hosseini, MD, PhD, chief medical officer of InSite Vision, said in the release.

Based on the positive results from two phase 3 clinical trials, InSite has scheduled a pre-new drug application meeting with the U.S. Food and Drug Administration in January and plans to file a new drug application in the second half of 2014. InSite also plans to seek regulatory approval for BromSite in Europe, the release said.