This article is more than 5 years old. Information may no longer be current.

FDA accepts application for InSite Vision's AzaSite

Add topic to email alerts

Receive an email when new articles are posted on

Please provide your email address to receive an email when new articles are posted on .

Subscribe

Added to email alerts

You've successfully added to your alerts. You will receive an email when new content is published.

Click Here to Manage Email Alerts

You've successfully added to your alerts. You will receive an email when new content is published.

Click Here to Manage Email Alerts

Back to Healio

We were unable to process your request. Please try again later. If you continue to have this issue please contact customerservice@slackinc.com.

Back to Healio

ALAMEDA, Calif. — The Food and Drug Administration has accepted for review a new drug application from InSite Vision for AzaSite for the treatment of bacterial conjunctivitis, the company announced.

The application contained data from two phase 3 clinical trials involving 698 patients treated with AzaSite (1% azithromycin in the DuraSite drug-delivery vehicle) twice daily for 2 days, and then once daily for 3 days.

In the study, AzaSite-treated patients showed both clinically and statistically significant improvements compared to placebo-treated patients, according to the release.

InSite Vision hopes to commercialize AzaSite in early 2007, company officials said in the release.