AzaSite approval signals $19 million milestone payment

The FDA has approved InSite Vision's New Drug Application (NDA) for AzaSite (azithromycin 1%) for the treatment of bacterial conjunctivitis.

AzaSite was shown to be safe and effective in two Phase III trials of more than 1,400 patients in the US and Latin America. The agent was administered twice daily for two days and then once daily for the next three days. The solution was found to offer clinically and statistically significant improvements in clinical resolution of symptoms and bacterial eradication compared with placebo.

AzaSite is formulated with DuraSite, InSite's patented drug delivery vehicle which is designed to enhance retention time of the antibiotic on the surface of the eye.

The approval has triggered a $19 million milestone payment from Inspire Pharmaceuticals, which has commercialization rights for AzaSite in the US and Canada.