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InSite Vision files IND for potential dry eye treatment
ALAMEDA, Calif. — InSite Vision has filed an investigational new drug application with the U.S. Food and Drug Administration for a novel compound that has shown potential for treating dry eye disease, the company announced.
ISV-101 combines a low dose of Ista Pharmaceutical's bromfenac ophthalmic solution with InSite Vision's proprietary DuraSite drug delivery system.
Accordingly, InSite Vision plans to launch a phase 1/2 clinical trial later this year evaluating the safety and efficacy of ISV-101 when administered twice daily to patients with dry eye disease. The five-arm trial will dose patients with three ISV-101 concentrations while comparing the effects of the drug when delivered via DuraSite against placebo vehicles, according to the release.
Results from the phase 1/2 study are expected to guide InSite as it formulates the ideal dose for ISV-101 to enter the third phase of clinical development.
"I am proud of our team's ability to expand our clinical development pipeline by advancing this novel new drug candidate for the treatment of dry eye disease," Timothy Ruane, CEO of InSite Vision, said in the release. "With patent protection extending into 2029, we believe ISV-101 can be well positioned to compete in the expanding $500 million U.S. dry eye market."