Ocular Therapeutix Receives CRL from FDA for Manufacturing Issues

Ocular Therapeutix, a biopharmaceutical company focused on eye-disease therapy development, manufacturing, and commercialization, has received a Complete Response Letter (CRL) from the US Food and Drug Administration (FDA) regarding its resubmission of a new drug application (NDA) for Dextenza (dexamethasone) 0.4mg for treating ocular pain following ophthalmic surgery.

The CRL refers to deficiencies in manufacturing processes and analytical testing related to the manufacture of the drug product for commercial production identified during a pre-NDA approval inspection of Ocular Therapeutix’s  manufacturing facility that was completed in May 2017. 

As previously announced on July 10, 2017, the company submitted a response intended to close out all inspectional observations included in the Form FDA-483 issued in May 2017. The company also submitted details of a manufacturing equipment change on July 10, 2017 as an amendment to the NDA resubmission and requested that this be considered a major amendment that would extend the target action date under the Prescription Drug User Fee Act.

The CRL acknowledges receipt of the company’s NDA amendment dated July 10, 2017 and states that the amendment was not reviewed prior to the FDA’s action of the CRL. As a result, the FDA did not have the opportunity to review the company’s close-out response prior to issuing the CRL. In addition, as noted in the CRL, the FDA indicated that applicable sections of the amendment submitted by Ocular Therapeutix could be incorporated when responding to deficiencies noted in the CRL.

Satisfactory resolution of the manufacturing deficiencies detailed in the Form FDA-483 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 for Dextenza provided in the NDA nor any need for additional clinical trials for the NDA approval, according to the company.

Source: Ocular Therapeutix


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