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NSAID drug delivery system reduces inflammation, pain in phase 3 trial
BromSite demonstrated statistically significant superiority compared with vehicle in a phase 3 clinical trial that evaluated the reduction of pain and inflammation after cataract surgery, according to a press release from InSite Vision.
InSite intends to begin a second phase 3 trial of BromSite (ISV-303), which combines 0.075% bromfenac with the proprietary DuraSite drug delivery system, in order to speed potential regulatory approvals in the United States and Europe, according to the release.
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.
No safety concerns or serious drug-related adverse events were reported, and BromSite was well tolerated, the release said.