Ocular Therapeutix receives CRL from FDA for its NDA for Dextenza

FDA reports deficiencies in manufacturing process and controls identified during a pre-NDA approval inspection of the Ocular Therapeutix manufacturing facility.

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.

“We have previously responded to all requests in an effort to address the manufacturing items raised by the FDA during the application process, and we await completion of the review,” said Amar Sawhney, President, Chief Executive Officer and Chairman. “Importantly, there were no clinical issues identified in the CRL pertaining to efficacy or safety related to the post-surgical pain indication. Labeling discussions with the FDA are ongoing. We remain optimistic that Dextenza will be approved once these open manufacturing items are closed. We will continue to work collaboratively with the FDA so they can finalize their review of our NDA, and are committed to bringing Dextenza to market as rapidly as possible.”