2004 AUG 9 - (NewsRx.com & NewsRx.net) -- InSite Vision Incorporated (ISV) has initiated two phase III pivotal studies for its lead drug candidate, AzaSite (formerly ISV-401), to demonstrate both safety and efficacy for treating acute bacterial conjunctivitis.
AzaSite pairs the broad-spectrum antibiotic azithromycin, not currently used in ophthalmology, with DuraSite, InSite Vision's proprietary, patented drug-delivery vehicle.
'Our phase III AzaSite trials are designed with a similar active ingredient concentration and dosing regimen as our phase II study in which we elicited clinical resolution and bacterial eradication of both gram-positive and gram-negative strains of acute bacterial conjunctivitis,' said S. Kumar Chandrasekaran PhD, InSite Vision's president and chief executive officer.
'Furthermore, AzaSite's prolonged release formulation allows for relatively low frequency dosing regimens of azithromycin, which we believe offers a significant advantage over currently marketed antibiotics in the nearly $1 billion U.S. ocular infection market.
'We are focused on bringing AzaSite through the regulatory process as swiftly as possible, and have now met our goal of initiating both phase III trials in the third-quarter,' said Chandrasekaran.
'Though there are always risks and potential delays in any clinical trial program, we currently expect to commercially launch AzaSite in the U.S. market in 2006.'
The first phase III trial is a multi-center vehicle-control study to be conducted in up to 60 clinical sites across the United States. It is designed to include 550 patients, of which 225 must be confirmed culture positive for acute bacterial conjunctivitis in at least one eye.
The second phase III trial, a multi-center active-control study to be conducted in up to 50 U.S. clinical sites, is designed to include approximately 775 patients, of which 310 must be confirmed culture-positive acute bacterial conjunctivitis in one eye.
InSite is using two clinical research organizations for monitoring and data management of the phase III trials.
InSite Vision is an ophthalmic products company focused on ocular infections, glaucoma and retinal diseases.
This article was prepared by Health & Medicine Week editors from staff and other reports. Copyright 2004, Health & Medicine Week via NewsRx.com & NewsRx.net.
