Ocular Therapeutix announced its receipt of a complete response letter (CRL) this week. The firm said the Food and Drug Administration raised questions about how Dextenza (dexamethasone) manufactured.
“The CRL refers to deficiencies in manufacturing processes and analytical testing related to manufacture of drug product for commercial production identified during a pre-NDA approval inspection of the Ocular Therapeutix manufacturing facility that was completed in May 2017,” the firm said.
Ocular’s CEO Amar Sawhney said the firm will persevere with the application process.
“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.”
“We believe that Dextenza can be approved once these open manufacturing items are resolved,” he said.
Dextenza’s regulatory issues
Dextenza is a hydrogel-based dexamethasone depot designed to be placed through the punctum, a natural opening in the tear duct, into the canaliculus. The insert delivers the corticosteroid to the ocular surface for up to one month.
FDA inspectors first raised concerns about the production process of Ocular’s Dextenza at the firm’s manufacturing facility in Bedford, Massachusetts, on February, 2016 in a Form 483.
The FDA then issued Ocular with a CRL in July, 2016, which stated the Administration would not evaluate the drug until production issues were addressed.
At the time, a company spokeswoman told in-PharmaTechnologist the original observations related to “proposed processing for identity testing of an inert gas component used in the Dextenza manufacturing process.”
Ocular re-submitted its NDA for Dextenza on January 23 of this year, yet received another Form 483 in May following the FDA’s re-inspection of the facility.
The company since informed the FDA of a manufacturing equipment change, and of a close out of all inspection observations included in the 483, on July 10.
Despite the firm requesting amendments be considered as part of the NDA, the FDA acknowledged the receipt of the July 10 amendment, but told Ocular it was not received prior to issuing the July 11 CRL.