Ocular Therapeutix Gets Complete Response Letter From FDA For Its NDA For DEXTENZA

Ocular Therapeutix, Inc. OCUL revealed Monday that it got a Complete Response Letter from the Food and Drug Administration (FDA) for its New Drug Application (NDA) for DEXTENZA 0.4 mg, for intracanalicular use in the treatment of ocular pain occurring after ophthalmic surgery. The regulator has raised some concerns in the manufacturing facility in the letter.

Ocular Therapeutix said the concerns raised by the regulator related to deficiencies in the process of manufacturing apart from controls identified during a pre-NDA approval inspection of its manufacturing facility. The company indicated that the FDA's letter did not offer any details as to which manufacturing deficiencies identified in the facility inspection remained open after the last response was submitted by it.

The company stated it needs to satisfy the manufacturing facility identified during the FDA facility inspection. Only then, the regulator would approve its NDA. The company pointed out that the FDA's letter did not specify any efficacy or safety concerns in respect of the clinical data provided in the NDA. The company also said that there was no need for any additional clinical trials for its NDA to get approved.

Ocular's President, CEO and Chairman, Amar Sawhney, said, "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. 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."

He added, "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."

On Monday, the stock fell 6.9 percent.