InSite Vision Inc. (OTCBB:INSV) has reached an agreement with the U.S.
InSite Vision Inc. (OTCBB:INSV) has reached an agreement with the U.S. Food and Drug Administration (FDA) on a Special Protocol Assessment (SPA) for the design of a Phase 3 clinical trial of AzaSite Plus and DexaSite in patients with blepharitis.
Blepharitis, also known as lid margin disease, is a very common eye disease in the United States and internationally. Characterized by inflammation of the eyelid, blepharitis is a chronic and recurring condition for which there is currently no FDA-approved treatment. The acute flare-ups of this disease can be painful and extremely irritating.
The DOUBle (Dual Ophthalmic agents Used in Blepharitis) study will seek to enroll 900 patients suffering from moderate-to-severe blepharitis in a four-arm trial designed to evaluate both product candidates simultaneously. An SPA is a written agreement with the FDA that the study design and planned analysis of the sponsor’s Phase 3 clinical trial adequately addresses the objectives necessary to support a regulatory submission.
InSite Vision is developing two Phase 3 product candidates formulated with the company’s proprietary DuraSite drug delivery platform for the treatment of blepharitis. AzaSite Plus, combines dexamethasone with the antibiotic AzaSite in DuraSite for the treatment of acute and chronic blepharitis. DexaSite, which combines dexamethasone with DuraSite, is intended to rapidly reduce inflammation in non-bacterial blepharitis.
InSite’s DuraSite sustained delivery technology is a patented synthetic polymer-based formulation designed to extend the residence time of a drug relative to conventional topical therapies. It enables topical delivery of a solution, gel or suspension and can be customized for delivering a wide variety of potential drug candidates. InSite vision is also applying DuraSite to multiple other clinical- and preclinical-stage product candidates to create a portfolio of novel ophthalmic products.
The study will utilize a proprietary quality of life questionnaire developed by InSite Vision in collaboration with leading clinicians and academic experts and the FDA to assess patient treatment experience and longitudinal comfort levels.
“It has been estimated that 34 million people in the United States suffer from blepharitis for which there is currently no approved pharmaceutical treatment,” said Timothy Ruane, Chief Executive Officer of InSite Vision. “Based on our clinical experience with AzaSite Plus and DexaSite, we believe that the design of the DOUBle Phase 3 program provides us with a unique opportunity to advance two promising products for the treatment of this disease in a single study.”