InSite Vision Inc. is clearly focused on a pivotal clinical trial of its compound ISV-401 to treat bacterial conjunctivitis. The Alameda, Calif-based ophthalmic products company said that following a meeting with the FDA, it has finalized its protocol and is moving ahead with plans to begin Phase III testing in the second quarter. ISV-401 combines a formulation of azithromycin, a broad-spectrum antibiotic not currently used in ophthalmology, with DuraSite, InSite's drug-delivery vehicle designed for prolonged release. The controlled study is based on the same formulation and dosing regimen used in a Phase II study. The protocol also allows inclusion of both pediatric and adult patients in a single trial rather than requiring separate trials for each set of patients. 'The endpoint for these studies - other than to ensure that there is good ocular health - is to examine bacterial eradication as well as clinical cure,' InSite President and CEO S. Kumar Chandrasekaran told BioWorld Today. 'One examines bacterial eradication as a function of time, and at the same time examines clinical cure, which is edema chemosis and things of that nature.'
