InSite Vision Initiates Confirmatory Phase 3 Clinical Study of BromSite™ for the Reduction of Inflammation and Pain after Cataract Surgery

New Drug Approvals

bromfenac

may9, 2013

InSite Vision Incorporated today announced that patient enrollment has begun in the confirmatory Phase 3 clinical trial of BromSite (ISV-303) for the reduction of inflammation and pain after cataract surgery. This study will seek to enroll approximately 240 patients undergoing cataract surgery in a two-arm trial designed to evaluate the efficacy and safety of BromSite against the DuraSite vehicle alone. BromSite combines a low dose (0.075%) of the non-steroidal anti-inflammatory drug (NSAID) bromfenac with InSite Vision’s DuraSite drug delivery technology.

 

Bromfenac is a non-steroidal anti-inflammatory drug (NSAID) marketed in the US as anophthalmic solution (current brand name Bromday, prior formulation brand name Xibrom, which has since been discontinued.) by ISTA Pharmaceuticals for short-term, local use. Bromday® is the once-daily formulation of bromfenac, while Xibrom®, which has since been discontinued, was the twice-daily formulation. Bromfenac is indicated for the treatment of ocular inflammation and pain after cataract surgery, though…

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