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Insite Vision finishes phase 3 trial of new anti-inflammatory drop
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The last patient in the first of two phase 3 clinical trials of Bromsite, an eye drop for the reduction of pain and inflammation after cataract surgery, has completed dosing and evaluation, according to an Insite Vision Inc. press release.
Bromsite combines a low dose (0.075%) of the nonsteroidal anti-inflammatory drug bromfenac with Insite Vision’s Durasite drug delivery technology, the release said.
The randomized study included more than 240 patients undergoing cataract surgery and was designed as a two-arm trial to evaluate the efficacy and safety of Bromsite against the Durasite vehicle alone. Patients were dosed twice a day 1 day before surgery, the day of surgery and 14 days postop, said the release.
The primary study endpoint is the reduction of postop inflammation, with a secondary endpoint of reduction in pain, according to the release.
Results from the study are expected to be available in the first quarter of 2013, according to the release.