AzaSite meets primary, secondary efficacy end points in phase 3 trial

ALAMEDA, Calif. — A proprietary vehicle that delivers azithromycin solution for the treatment of bacterial conjunctivitis had a “significantly higher clinical resolution rate … and a significantly higher bacterial eradication rate than those on placebo,” the drug’s developer said in a press release.

InSite Vision’s AzaSite (1% azithromycin solution in DuraSite) completed the second of two phase 3 trials. The trial involved 685 people, of whom 240 were between 1 and 16 years old. All had confirmed bacterial conjunctivitis. Participants were randomized to placebo or AzaSite for 5 days. The drops were dosed twice a day for the first 2 days, then once daily for the next 3 days.

“Top line results showed that the clinical resolution rate, the trials’ primary efficacy end point, was significantly higher in subjects treated with AzaSite than those treated with placebo. Furthermore, the bacterial eradication rate, the trial’s secondary efficacy end point, was also significantly higher in the AzaSite treated group,” the release said.

There were no reports of systemic drug sensitivity or serious adverse events.

InSite expects to release full data on the study at an upcoming international ophthalmic meeting, the release said.