INSITE SUBMITS APPLICATION FOR CONJUNCTIVITIS DRUG

InSite Vision announced the FDA has accepted for review the company's new drug application for AzaSite (azithromycin 1 percent ophthalmic solution), indicated for the treatment of bacterial conjunctivitis. AzaSite is formulated with DuraSite, InSite's patented drug delivery vehicle that enhances the retention time of the antibiotic on the surface of the target tissue.

The application contains data from two Phase III clinical trials in which 698 patients were treated with AzaSite. Data from these studies demonstrated that when the drug was administered twice daily on the first two days, then once daily on days three through five, it provided clinically and statistically significant improvements in clinical resolution of symptoms and bacterial eradication compared with placebo. The drug was also found to be equivalent in clinical resolution and bacterial eradication compared with tobramycin administered four times a day.