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

Supplemental NDA accepted for Dextenza inflammation indication

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

The FDA has accepted a supplemental new drug application for Dextenza for the treatment of ocular inflammation following ophthalmic surgery, Ocular Therapeutix announced.

Dextenza (dexamethasone ophthalmic insert 0.4 mg) is the first FDA-approved intracanalicular insert to treat post-surgical ocular pain.

The supplemental NDA is supported by the two phase 3 clinical trials used to obtain the pain approval, and safety and efficacy data from a third prospective, multicenter, randomized phase 3 clinical trial in cataract surgery patients, according to a press release.

A PDUFA date has been set for Nov. 10.