FDA denies NDA for Dextenza

The FDA has sent a complete response letter to Ocular Therapeutix saying it cannot approve the Dextenza new drug application “in its present form,” according to a company press release.

The letter did not raise any concerns regarding efficacy or safety of the clinical data in the NDA or request additional clinical trials for approval.

In May, the FDA found “deficiencies in manufacturing processes and analytical testing related to manufacture of drug product for commercial production” during an inspection. Earlier this week, Ocular Therapeutix submitted a response to close out these observations, detailing a manufacturing equipment change as part of an amendment to the NDA and requesting an extension to the target action date under PDUFA.

The CRL acknowledged the FDA received the amendment but said that it was not reviewed before the FDA’s action. “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,” according to the release.

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

The FDA has sent a complete response letter to Ocular Therapeutix saying it cannot approve the Dextenza new drug application “in its present form,” according to a company press release.

The letter did not raise any concerns regarding efficacy or safety of the clinical data in the NDA or request additional clinical trials for approval.

In May, the FDA found “deficiencies in manufacturing processes and analytical testing related to manufacture of drug product for commercial production” during an inspection. Earlier this week, Ocular Therapeutix submitted a response to close out these observations, detailing a manufacturing equipment change as part of an amendment to the NDA and requesting an extension to the target action date under PDUFA.

The CRL acknowledged the FDA received the amendment but said that it was not reviewed before the FDA’s action. “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,” according to the release.

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