In the study, patients treated with AzaSite had a significantly higher clinical resolution rate, the trial’s primary efficacy end point, and a significantly higher bacterial eradication rate, a secondary end point, than those receiving placebo. Importantly, the study also showed that AzaSite was safe and well tolerated.
“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,” Dr S Kumar Chandrasekaran, InSite Vision’s CEO.
This second of two phase III trials was an international, double-blind, randomized, vehicle-controlled study that was conducted at 42 centers in the US and 11 in Mexico and Central America.
The trial enrolled 685 subjects of which 240 ranged in age from 1 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 placebo or AzaSite for 5 days. The drops were dosed twice a day for the first 2 days, followed by once a day for the next three days.