BromSite success in Phase III trial for Cataract-InSite Vision
Top-line results from a Phase III clinical trial of BromSite (bromfenac + DuraSite delivery), from InSite Vision, for the reduction of inflammation and pain after Cataract Surgery confirm results from its first Phase III trial. The confirmatory trial enrolled 248 patients undergoing cataract surgery in a two-arm trial designed to evaluate the efficacy and safety of BromSite against the DuraSite vehicle alone. Patients were randomized and then dosed twice-a-day beginning the day before surgery and continuing the day of surgery and for 14 days post-surgery.
In this second pivotal trial, BromSite achieved statistically significant superiority compared to vehicle in alleviating ocular inflammation at Day 15 among patients following cataract surgery compared to the vehicle arm. BromSite also achieved statistically significant superiority compared to vehicle for the secondary endpoint of post-surgical reduction in pain. BromSite was well tolerated, with no safety concerns or drug-related serious adverse events reported. The company expects there will be a New Drug Application regulatory filing for BromSite in the second half of 2014.
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