FDA raises concerns about manufacturing deficiencies in Dextenza complete response letter

Ocular Therapeutix received a complete response letter from the FDA regarding the new drug application for Dextenza for the treatment of postoperative ocular pain, according to a press release.

The letter addresses the FDA’s concerns about the deficiencies in the manufacturing process and controls that were identified during a pre-NDA approval inspection of the company’s manufacturing facility, but the FDA did not provide details on which manufacturing deficiencies were identified.

“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,” Amar Sawhney, PhD, president, CEO and chairman of Ocular Therapeutix, said in the release.

No efficacy or safety concerns were addressed in the letter, nor were additional clinical trials requested for the approval of the NDA.

“Labeling discussions with the FDA are ongoing. We remain optimistic that Dextenza (dexamethasone insert 0.4 mg) will be approved once these open manufacturing items are closed,” Sawhney said in the release. “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.”