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.
“We are pleased with the recent news that the FDA has formally accepted our resubmission of the Dextenza NDA” president & CEO Antony Mattessich said in prepared remarks. “This marks one more important step towards our goal of bringing this important new treatment to the market.”
Ocular Therapeutix’s Dextenza device is designed to deliver a sustained dose of dexamethasone over four weeks following eye surgery, at which point it resorbs and exits the patient’s nasolacrimal system. The company is first pursuing a pain relief indication from the FDA but has its sights set on inflammation and allergic conjunctivitis indications as well.
OCUL shares were trading at $6.41 apiece in mid-morning activity, up +2.2%.