Ocular Therapeutix has resubmitted a new drug application to the FDA for its ocular pain treatment Dextenza, the company announced in a press release.
Dextenza (dexamethasone insert 0.4 mg) is a corticosteroid intracanalicular insert placed through the punctum to deliver dexamethasone for up to 30 days.
A complete response letter from the FDA in July 2017 cited manufacturing deficiencies, the release said. This resubmission addresses those citations.
“Since last July, we have worked to make substantial improvements in our manufacturing processes and quality oversight that have allowed us to reach this important milestone,” Antony Mattessich, president and CEO of Ocular Therapeutix, said in the release. “However, while the resubmission is significant, our focus remains on the end goal of making Dextenza available to physicians and patients.”
The company expects a 6-month review with a possible target action date under the Prescription Drug User Fee Act at the end of 2018, the release said.