Ocular Therapeutix seeks second indication for drug-delivery eye insert

Ocular Therapeutix (NSDQ:OCUL) said yesterday that it submitted a supplement NDA to the FDA for its dexamethasone ocular insert, Dextenza.

The Bedford, Mass.-based company requested that the U.S. regulatory agency expand the current indication for Dextenza to include the treatment of ocular inflammation following eye surgery.

Dextenza is designed to deliver drugs for up to 30 days following treatment in a physician’s office. The company’s drug-delivery device was approved in November for the treatment of pain following eye surgery.

Ocular Therapeutix said it expects the FDA will finish reviewing its sNDA in the second half of 2019.

“Submission of this sNDA on the heels of the initial Dextenza approval is another significant milestone for Ocular Therapeutix. The potential market opportunity for postoperative ocular pain and inflammation is substantial and there remains an important unmet need to address the issue of non-compliance given currently available treatment options,” president & CEO Antony Mattessich said in prepared remarks. “This is another major step toward our goal of making eye-drop therapies obsolete.”

OCUL shares closed yesterday at $4.00 apiece, down -3.6%.

Want to stay on top of DDBN content? Sign up for our e-mail newsletter for a weekly dose of drug-device news.

Theranos whistleblower Tyler Shultz to participate in keynote interview at DeviceTalks Boston At DeviceTalks Boston, Tyler Shultz will give attendees an inside look at Theranos and how he was able to sound the alarm after he realized the company was falling apart. Shultz will take attendees behind the story that everyone is talking about: the rise and fall of Elizabeth Holmes and her diagnostic company, Theranos. Join Shultz and 1,000+ medical device professionals at the 8th annual DeviceTalks Boston. REGISTER NOW