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

Dry eye drug to get priority review from FDA

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

DURHAM, N.C. — Diquafosol tetrasodium ophthalmic solution has been granted a priority review by the Food and Drug Administration for the treatment of dry eye, according to a news release from the drug’s manufacturer, Inspire Pharmaceuticals.

Under the priority review status, a target date for initial FDA action is 6 months from the drug’s submission. Inspire submitted its new drug application on June 27. The NDA included data from phase 2 and 3 studies involving more than 1,200 patients with dry eye, the news release stated.

According to the release, Inspire is already working with the FDA on various aspects of the submission and will continue to build its infrastructure to copromote the drug in the United States with Allergan.

“Given the possibility of accelerated action on the diquafosol NDA, we intend to have our sales force ready for a potential first quarter 2004 launch,” said Christy Shaffer, PhD, chief executive officer of Inspire.