The Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) resubmission for Dextenza (dexamethasone insert; Ocular Therapeutix) for the treatment of ocular pain after ophthalmic surgery.
The NDA for Dextenza was resubmitted in January 2017 following a Complete Response Letter that was issued in July 2016 due to concerns with deficiencies in manufacturing processes and controls. The FDA determined that the resubmission is a complete response, with a Class 2 review designation and a Prescription Drug User Fee Act (PDUFA) target action date of July 19, 2017.
Ocular Therapeutix has completed three Phase 3 clinical trials for Dextenza in post-surgical ocular inflammation and pain. The Company is also conducting additional Phase 3 trials to expand its indication for the treatment of ocular itching associated with allergic conjunctivitis.
Dextenza, a 0.4mg bioresorbable intracanalicular insert, is designed to deliver a tapered dose of dexamethasone to the ocular surface for up to 30 days.
For more information call (877) 628-8998 or visit Ocutx.com.