The FDA is to review the New Drug Application (NDA) for Dextenza (sustained-release dexamethasone), an intracanalicular depot for the treatment of ocular pain following ophthalmic surgery. The announcement was made today by Ocular Therapeutix.
The NDA submission is based on data from Phase 2 and two Phase 3 clinical trials which evaluated Dextenza for the treatment of post-surgical ocular pain and inflammation. The company recently initiated a third Phase 3 clinical trial for the same indication. The FDA has set a target action date of July 24 2016, under the Prescription Drug User Fee Act (PDUFA).
In addition to the ocular pain indication, Ocular Therapeutix is also pursuing other potential indications for Dextenza, including the treatment of ocular itching associated with allergic conjunctivitis and symptoms associated with inflammatory dry eye disease. The company intends to submit supplements to the NDA for these indications to expand the label for Dextenza.
Dextenza Intracanalicular Depot is designed to deliver dexamethasone to the ocular surface for 4 weeks.
For more information call (877) 628-8998 or visit Ocutx.com.