InSite Vision Incorporated, an ophthalmic therapeutics, diagnostics and drug delivery company, announce that a phase 1 (safety) clinical study for AzaSite Plus (ISV-502), a combination antibiotic/corticosteroid, has been initiated. AzaSite Plus, the next product in the AzaSite product franchise, combines azithromycin and dexamethasone in DuraSite, which is InSite Vision's drug delivery system for topical ophthalmic indications.
AzaSite Plus provides the broad bacteria coverage of InSite Vision's AzaSite product (for which an NDA has been filed), featuring reduced dosing and drug safety, while the addition of dexamethasone provides a proven steroid for the treatment of ocular inflammation. The product would be indicated for ocular treatment where inflammation and bacterial infection are present, typically represented in conditions such as blepharitis. The phase 1 clinical study is intended to evaluate both the safety and tolerability of the AzaSite Plus formulation in normal volunteers.
Kumar S Chandrasekaran, Ph.D., president and CEO stated, "The AzaSite Plus phase 1 clinical trial is an important milestone for InSite Vision, as we initiate the clinical testing of the next product in the AzaSite product franchise. We expect this product to expand the overall market for our AzaSite franchise to other significant indications, based on the demonstrated efficacy and convenience of our AzaSite product."