FDA OKs azithromycin 1% ophthalmic solution

Alameda, CA-InSite Vision Inc. expects its azithromycin 1% ophthalmic solution (Aza- Site) to be launched commercially in the United States in the second half of this year now that the FDA has approved the company's new drug application.

The topical anti-infective, for the treatment of bacterial conjunctivitis, is formulated with the company's patented drug-delivery vehicle (DuraSite), designed to enhance the retention time of the antibiotic on the surface of the eye.

The approval follows completion of two phase III clinical trials conducted in more than 1,400 patients in the United States and Latin America. In these studies, the solution was administered twice daily on the first 2 days, then once daily on the third, fourth, and fifth days. Results demonstrated that the anti-infective solution provided clinically and statistically significant improvements in clinical resolution of symptoms and bacterial eradication compared with placebo. Also, the agent was found to be equivalent in clinical resolution and bacterial eradication when compared with tobramycin administered four times a day for 5 days.

Under the terms of a previously announced license agreement, Inspire Pharmaceuticals will commercialize the topical solution in the United States and Canada. The FDA approval triggered a $19 million payment from Inspire Pharmaceuticals to InSite Vision.

To gain exclusive marketing rights to the anti-infective, Inspire Pharmaceuticals initially paid InSite Vision $13 million. Inspire Pharmaceuticals also will pay a royalty-20% in the first 2 years of commercialization and 25% thereafter-on net sales of the antibiotic in the United States and Canada.

InSite Vision is pursuing additional commercial partnerships to market the solution in other geographic areas.