InSite Vision has selected Quintiles to manage the DOUBle Phase III trial of AzaSite Plus and DexaSite for the treatment of blepharitis. In May 2011, InSite Vision obtained a Special Protocol Assessment (SPA) from the FDA for the DOUBle Trial.
AzaSite Plus and DexaSite are formulated with the company’s proprietary DuraSite drug delivery platform: AzaSite Plus combines dexamethasone 0.1% with the antibiotic AzaSite (azithromycin 1% ophthalmic solution) in DuraSite and DexaSite combines dexamethasone 0.1% with DuraSite. The DOUBle (Dual Ophthalmic agents Used in Blepharitis) study will seek to enroll approximately 900 patients suffering from moderate-to-severe blepharitis in a four-arm trial designed to evaluate both product candidates simultaneously.
“We are very pleased to partner with Quintiles for our pending DOUBle Phase III clinical trial. Quintiles’ extensive track record in facilitating the development and commercialization of best-selling drugs significantly reduces execution risks, while providing InSite with access to a wealth of potential services that we may utilize in the future,” said Timothy Ruane, chief executive officer of InSite Vision.
Blepharitis, also known as lid margin disease, is a very common eye disease. Characterized by inflammation of the eyelid, blepharitis is a chronic and recurring condition for which there is currently no FDA-approved treatment.