InSite Vision Completes Confirmatory Phase 3 Clinical Study of BromSite for the Reduction of Inflammation & Pain Following Ca...
Date : 11/07/2013 @ 4:30PM
Source : Business Wire
Stock : Insite Vision, Inc. (QB) (INSV)
Quote : 0.26 0.02 (8.33%) @ 2:03PM
InSite Vision Completes Confirmatory Phase 3 Clinical Study of BromSite for the Reduction of Inflammation & Pain Following Ca...
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Insite Vision, Inc. (QB) (USOTC:INSV)
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Last Patient Concludes Dosing and Evaluation
InSite Vision Incorporated (OTCBB:INSV) today announced that the last patient has completed dosing and evaluation in the confirmatory Phase 3 clinical trial of BromSite™ (ISV-303) for the reduction of inflammation and pain after cataract surgery. BromSite combines a low dose (0.075%) of the non-steroidal anti-inflammatory drug (NSAID) bromfenac with InSite Vision’s DuraSite® drug delivery technology.
InSite Vision expects that top-line data from the BromSite confirmatory Phase 3 clinical trial will be available before the end of 2013. This study 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, continuing the day of surgery and for 14 days post-surgery. The primary study endpoint is the reduction of inflammation after surgery as compared to vehicle, with the secondary endpoint of reduction in pain. The endpoints for the confirmatory study are the same as those used in the prior BromSite Phase 3 clinical trial.
In March 2013, InSite Vision announced positive results from the first Phase 3 clinical study of BromSite. In that study, BromSite achieved statistically significant superiority to vehicle (p<0.001) for primary endpoint of reduction in inflammation. The confirmatory study for BromSite was designed with full input from both the U.S. Food and Drug Administration and the European regulatory authorities. Pharm-Olam International served as the contract research organization managing the BromSite Phase 3 clinical program on behalf of InSite Vision.
About Cataract Surgery
