Ocular Therapeutix announced that it has submitted details of a manufacturing equipment change as an amendment to the NDA resubmission for Dextenza (dexamethasone insert) 0.4 mg, for intracanalicular use, for the treatment of ocular pain following ophthalmic surgery currently under review by the FDA.
The company is requesting FDA to consider this submission a major amendment and extend the current NDA target action date of July 19, 2017 under the Prescription Drug Fee User Act (PDUFA) by 3 months and to review the submission during the current review cycle. As detailed in the amendment, Ocular Therapeutix has modified a piece of manufacturing equipment referenced in the NDA resubmission and will be submitting data on a new commercial batch to demonstrate that this modification, along with other improvements, has addressed outstanding issues regarding particulate matter.
As previously announced, following the completion of a reinspection of manufacturing operations by the FDA, Ocular Therapeutix received an FDA Form 483 in May 2017. This report contained inspectional observations focused on procedures and training protocols for manufacturing processes and analytical testing related to commercial manufacturing of Dextenza. The company submitted to the FDA its initial corrective action plans within 15 days of receipt of the Form 483 and has remained in ongoing communication with the FDA.
On July 10, 2017, Ocular Therapeutix submitted a close-out response to all inspectional observations included in the FDA Form 483 issued in May 2017. The close-out response focused on the characterization of particulates, defining and recognizing their source, implementing appropriate corrective and preventive actions, and revising training protocols and documents for manufacturing technicians. Adequate resolution of the outstanding Form 483 inspectional observations is a prerequisite to the approval of the NDA for Dextenza.
The company follows appropriate industry guidance that permits specific tolerance levels in batch release qualifications. Inspection of all Dextenza batches has been an integral standard operating procedure within Ocular’s manufacturing and quality control processes, with each dose (insert) inspected individually. Ocular Therapeutix maintains stringent manufacturing standards and conducts a 100% in-process inspection for Dextenza. Any inserts that do not pass inspection cannot be, and have not been, considered for either clinical or commercial use.
“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, Chief Executive Officer and Chairman, said in a company news 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.”