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FDA accepts Dextenza NDA

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The FDA has accepted a new drug application resubmission for Dextenza, according to an Ocular Therapeutix 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.

The NDA resubmission is considered by the FDA as a class 2 response to its complete response letter, which was issued in July 2017 and cited manufacturing deficiencies. A Prescription Drug User Fee Act date of Dec. 28 has been issued for the FDA’s review of the NDA, the release said.

“We are pleased with recent news that the FDA has formally accepted our resubmission of the Dextenza NDA,” Ocular Therapeutix CEO and President Antony Mattessich said in the release. “This marks one more important step towards our goal of bringing this important new treatment to the market.”