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

11 05 2013

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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