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news.InSite Vision has entered into an agreement with the US Food and Drug Administration (FDA) on a Special Protocol Assessment (SPA) in connection with the study design of a controlled and blinded multicenter DOUBle (Dual Ophthalmic agents Used in Blepharitis) Phase 3 clinical trial to evaluate AzaSite Plus (ISV-502) and DexaSite (ISV-305) in patients suffering from blepharitis.
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The company expects to recruit around 900 patients suffering from moderate-to-severe blepharitis in a four-arm trial designed to evaluate both product candidates simultaneously.
The efficacy and safety of DexaSite and AzaSite will be measured against the DuraSite vehicle for resolution of clinical signs and symptoms of blepharitis.
The Phase 3 clinical trial will enroll patients into one of four study arms to assess the efficacy and safety of both AzaSite Plus and DexaSite in treating blepharitis.
InSite Vision CEO Timothy Ruane said the SPA agreement with the FDA represents a thorough and collaborative effort between the company and the agency that provides the best chance for AzaSite Plus and/or DexaSite to be the first drugs approved for the treatment of blepharitis.
"Based on our clinical experience with AzaSite Plus and DexaSite, including a completed Phase 3 study in blepharoconjunctivitis, we believe that the design of the DOUBle Phase 3 program provides us with an opportunity to advance two promising products for the treatment of this disease in a single study," Ruane said.