The company said that BromSite (ISV-303) combines a low dose (0.075%) of the non-steroidal anti-inflammatory drug (NSAID) bromfenac with its DuraSite drug delivery technology.
This study reportedly enrolled more than 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 primary study endpoint is the reduction of inflammation after surgery, with a secondary endpoint of reduction in pain. The top-line data from the BromSite Phase 3 clinical trial is expected to available in the first quarter of 2013.
According to the company, the trial is the first of two Phase 3 clinical studies in support of BromSite’s regulatory submissions. The second Phase 3 study of BromSite will be finalised pending full input from both the US Food and Drug Administration and European regulatory authorities.
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