Biopharmaceutical company focused on the development, manufacture and commercialisation of therapies for ocular conditions, Ocular Therapeutix, has received a complete response letter (CRL) regarding its resubmission of a new drug application (NDA) for its dexamethasone implant.
Response letter
The letter, sent by the US Food and Drug Administration (FDA), has stated that an approval for the NDA of DEXTENZA 0.4 mg for the treatment of post-surgical ocular pain cannot be granted in the current form. Deficiencies in the manufacturing process and analytical testing in relation to the manufacture of the drug product for commercial production were highlighted in the CRL. These issues were identified during an inspection of the company’s manufacturing facility that was completed back in May.
Ocular Therapeutix had submitted a response to the issues identified in May and also the details of a change in manufacturing equipment on 10 July. However, even though the CRL acknowledges receipt of these changes, the FDA did not have chance to review them prior to issuing the letter. Although, it was noted in the CRL that is possible for Ocular Therapeutix to incorporate applicable sections of the amendments it made in the response to the deficiencies notification.
All manufacturing deficiencies are required to be resolved before the NDA can reach approval status. However, the FDA did not indicate any efficacy or safety concerns relating to the clinical data presented for the dexamethasone implant nor did it specify any requirement for additional clinical trials to be performed for the NDA application.
“We are evaluating the FDA’s response and plan to work closely with the agency in an effort to satisfy the requirements related to the NDA,” said Ocular Therapeutix president, chief executive officer and Chairman, Amar Sawhney, PhD. “Importantly, there were no clinical issues identified in the CRL pertaining to efficacy or safety related to the post-surgical pain indication. We believe that DEXTENZA can be approved once these open manufacturing items are resolved.”