Posted by Michael Wonder on 25 Jul 2016
Ocular Therapeutix receives complete response letter from FDA for its NDA for Dextenza for the treatment of post-surgical ocular pain
25 July 2016 - Outstanding items pertain to manufacturing process and controls.
Ocular Therapeutix today announced that it received a complete response letter from the U.S. FDA regarding its New Drug Application (NDA) for Dextenza (dexamethasone) 0.4 mg insert for intracanalicular use in the treatment of ocular pain occurring after ophthalmic surgery.
The concerns raised by the FDA pertain to deficiencies in manufacturing process and controls identified during a pre-NDA approval inspection of the Ocular Therapeutix manufacturing facility. The FDA’s letter did not provide any details as to which manufacturing deficiencies identified during the facility inspection remain open since the last response submitted by the Company.
Satisfactory resolution of the manufacturing deficiencies identified during the FDA facility inspection is required before the NDA may be approved. The FDA’s letter did not identify any efficacy or safety concerns with respect to the clinical data provided in the NDA nor any need for additional clinical trials for the approval of the NDA.
