Sunday, January 16, 2011

Viewing Topic: INVS Files IND for ISV101 with the US Food and Drug Administration for

InSite Vision anticipates initiating a Phase 1/2 clinical trial in 2011 to evaluate the safety and efficacy of ISV-101 when administered twice daily to patients suffering from dry eye disease. The five-arm trial design will include three ISV-101 dose concentrations and comparisons against DuraSite and non-DuraSite (placebo) vehicles. Data from the Phase 1/2 study are expected to provide guidance on the ideal dose for ISV-101 and the design of a Phase 3 clinical program.


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