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news.InSite Vision has reported positive top-line results from its Phase 1/2 clinical trial of ISV-303, a topical anti-inflammatory product intended to reduce the pain and inflammation associated with ocular surgery.
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The randomised four-arm Phase 1/2 study was designed to compare once- and twice-daily doses of ISV-303 versus Xibrom and DuraSite (vehicle), each administered twice-daily.
The trial enrolled 169 patients undergoing cataract surgery.
The primary endpoint of the study was the absence of cells in the anterior chamber of the eye at day 15 following surgery.
The study results showed that once-daily ISV-303 achieved statistically significant superiority compared to vehicle for the primary endpoint.
Secondary endpoints such as reduction of flare, pain and discomfort as a result of inflammation, achieved statistically significant superiority at days 8, 15 and 29 as compared with vehicle.
ISV-303, Xibrom and vehicle were all generally well tolerated without any safety concerns or serious adverse events related to any of the agents.
ISV-303 combines a lower dose (0.075%) of the non-steroidal anti-inflammatory (NSAID) bromfenac/ bromfenac ophthalmic solution 0.09%, with InSite Vision‘s proprietary DuraSite drug delivery technology.