InSite Vision Incorporated (OTCBB:INSV) today announced that the Company 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™ (ISV-502) and DexaSite™ (ISV-305) in patients with blepharitis. 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.
“The SPA Agreement with the FDA represents a thorough and collaborative effort between the Company and the Agency that we believe provides the best chance for AzaSite Plus and/or DexaSite to be the first drugs approved for the treatment of blepharitis. The clinical development team at InSite Vision, led by our Chief Medical Officer, Dr. Kamran Hosseini, did a spectacular job in reaching this agreement with the Agency,” said Timothy Ruane, Chief Executive Officer of InSite Vision.
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 0.1% with the antibiotic AzaSite® (azithromycin 1% ophthalmic solution) in DuraSite for the treatment of acute and chronic blepharitis. DexaSite, which combines dexamethasone 0.1% with DuraSite, is intended to rapidly reduce inflammation in non-bacterial blepharitis.
Mr. Ruane continued, “Blepharitis is a complex, chronic condition in which patients experience acute flare-ups. It has been estimated that 34 million people in the United States suffer from blepharitis for which there is currently no approved pharmaceutical treatment. 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 a unique opportunity to advance two promising products for the treatment of this disease in a single study.”
Phase 3 Trial Design
The controlled and blinded multicenter 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. Patients will be randomized to receive treatment with AzaSite Plus, DexaSite, AzaSite, or the DuraSite vehicle twice-daily for 14 days. AzaSite Plus efficacy will be measured against the ocular antibiotic AzaSite and the DuraSite vehicle for the resolution of the clinical signs and symptoms of blepharitis. The efficacy of AzaSite Plus will also be measured against DexaSite in terms of time to recurrence in patients who achieved complete resolution of clinical signs and symptoms of blepharitis following the treatment period. The efficacy and safety of DexaSite and AzaSite will be measured against the DuraSite vehicle for resolution of clinical signs and symptoms of blepharitis. Finally, all patients who do not experience complete resolution of clinical signs and symptoms of blepharitis following the treatment period will continue to be assessed during the follow-up period for improvements or exacerbation of their disease. The follow-up period will be six months. Patients will be quantitatively assessed using a proprietary physician scoring tool, BleSSSED, and also by standardized digital photography. The study will utilize a proprietary quality of life (BleQOLITY) 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.
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.
About DuraSite®
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. The DuraSite platform is currently leveraged in two commercial products for the treatment of bacterial eye infections, AzaSite and Besivance™ (besifloxacin 0.6% ophthalmic suspension). InSite vision is also applying DuraSite to multiple other clinical- and preclinical-stage product candidates to create a portfolio of novel ophthalmic products.
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InSite Vision Incorporated
View drug information on AzaSite; Besivance.