InSite Vision says phase 3 clinical trials meet primary, secondary efficacy endpoints

By E. Janene Geiss

Philadelphia, March 14 - InSite Vision Inc. announced Tuesday top-line results from the second of two required phase 3 clinical trials to evaluate the safety and efficacy of AzaSite (1.0% azithromycin solution in DuraSite) anti-infective eye drops in patients with bacterial conjunctivitis.

In a study to show superiority of AzaSite relative to vehicle, patients treated with AzaSite had a significantly higher clinical resolution rate, the trial's primary efficacy endpoint and a significantly higher bacterial eradication rate, a secondary endpoint, than those receiving a placebo, according to a company news release.

The study also showed that AzaSite was safe and well-tolerated. The data from which these top-line clinical results were drawn will be reported at an upcoming ophthalmology conference, officials said.

"The data demonstrates the success of our strategy to use the DuraSite platform to develop anti-infective therapies with reduced dosing frequency. The clinical resolution rate of less frequently dosed AzaSite is comparable to the best selling ophthalmic antibiotic products. The reduced dosing frequency can lead to improved compliance, greater patient convenience and better therapeutic outcomes," S. Kumar Chandrasekaran, InSite's chief executive officer, said in the release.

The company said it plans to file a New Drug Application with the Food and Drug Administration this year.

The trial was an international, double-blind, randomized, vehicle-controlled study that was conducted at 42 centers in the United States and 11 in Mexico and Central America.

The trial enrolled 685 subjects of which 240 ranged in age from one to 16 years. Those subjects with confirmed bacterial conjunctivitis (pink-eye), a common infectious ocular disease, were evaluated for efficacy, whereas all subjects enrolled in the trial were evaluated for safety.

Trial participants received eye drops of either a placebo or AzaSite for five days. The drops were dosed twice a day for the first two days, followed by once a day for the next three days. Demographic characteristics were evenly distributed across treatment groups.

InSite, based in Alameda, Calif., is an ophthalmic company focused on developing therapies that treat ocular infections, glaucoma and retinal diseases.

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