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Antibiotic drug, delivery vehicle enter phase 3 trial

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ALAMEDA, Calif. — A combination of the antibiotic azithromycin with a drug delivery vehicle has entered pivotal phase 3 trials for the treatment of acute bacterial conjunctivitis, according to the developer.

InSite Vision said it has begun two pivotal phase 3 trials of AzaSite, formerly known as ISV-401, a combination of azithromycin with DuraSite, the company’s patented drug delivery vehicle. The first trial is a multicenter vehicle-control study to be conducted in up to 60 clinical sites throughout the United States. The trial will include 550 patients, of whom at least 225 will have confirmed, culture-positive results for acute bacterial conjunctivitis in at least one eye.

The second trial will be a multicenter active-control study in up to 50 U.S. clinical sites. It will include 775 patients, of whom 310 will have confirmed, culture-positive acute bacterial conjunctivitis in one eye.

InSite’s president and chief executive officer, S. Kumar Chandrasekaran, PhD, said in a press release that the company expects to launch AzaSite commercially in the U.S. market in 2006.