Ocular Therapeutix (NSDQ:OCUL) said today that the FDA formally accepted its resubmitted new drug application for Dextenza, an ocular implant designed to administer pain-relief drugs following ophthalmic surgery.
The FDA issued a complete response letter to the Bedford, Mass.-based company last year, rejecting Ocular’s Dextenza application for the second time. The U.S. regulatory agency is set to decide whether or not to approve Dextenza based on its revised application by Dec. 28.
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.