Ocular Therapeutix has submitted an amendment to its FDA new drug application resubmission for Dextenza, detailing a manufacturing equipment change, according to a company press release.
The company has modified a piece of equipment referenced in its NDA resubmission and will submit data on a new commercial batch to show that the change has addressed issues regarding particulate matter, the release said.
The current NDA target action date for Dextenza (dexamethasone insert 0.4 mg) is July 19. Ocular Therapeutix is asking the FDA to extend that date under PDUFA by 3 months to review the modification.
The FDA issued Form 483 to Ocular Therapeutix in May after re-inspecting manufacturing operations, focusing “on procedures and training protocols for manufacturing processes and analytical testing related to commercial manufacturing of Dextenza,” the release said.
The company submitted a close-out response to these observations on July 10.
“We believe that the recent submission of our close-out response to the Form 483 and subsequent submission of the amendment to our NDA resubmission for FDA’s consideration can support an acceptable regulatory pathway for the approval of Dextenza,” Amar Sawhney, PhD, president, CEO and chairman of Ocular Therapeutix, said in the release. “We continue to be in close communication with the FDA to determine the best course of action in an effort to successfully bring Dextenza to market.”