Ocular Therapeutix announced that the FDA issued a complete response letter regarding its resubmitted marketing application for Dextenza (dexamethasone) for intracanalicular use to treat ocular pain occurring after ophthalmic surgery. The company's shares fell more than 25 percent on the news.
In the letter, the FDA referred to deficiencies in manufacturing processes and analytical testing uncovered during a pre-approval inspection of the company's production site that was completed in May. Earlier this week, Ocular Therapeutix submitted a response intended to address all observations included in the inspection report issued in May, along with details of a manufacturing equipment change as an amendment to its new drug application (NDA) resubmission.
Ocular Therapeutix noted that while the FDA acknowledged receipt of the amended NDA, the regulator did not have the opportunity to review it prior to issuing the complete response letter. The company also pointed out that the letter did not identify any efficacy or safety concerns with respect to the clinical data for Dextenza, or any need for additional clinical trials for the NDA approval.
CEO Amar Sawhney remarked that "we are evaluating the FDA's response and plan to work closely with the agency in an effort to satisfy the requirements related NDA." He added "we believe that Dextenza can be approved once these open manufacturing items are resolved."
The FDA initially declined to approve the product in July 2016, citing deficiencies in manufacturing processes and controls found during a pre-approval inspection of its production facility. The Dextenza insert is designed to be placed through the punctum into the canaliculus, where it delivers dexamethasone to the ocular surface for up to 30 days.
To read more Top Story articles, click here.