Ocular Therapeutix Announces FDA Acceptance of NDA Resubmission for Dextenza

Ocular Therapeutix announced that it has received acknowledgement from the FDA that the new drug application (NDA) for Dextenza has been received. Dextenza (dexamethasone insert) 0.4 mg is Ocular Therapeutix’s lead product candidate for the treatment of ocular pain following ophthalmic surgery. The FDA considers the NDA resubmission as a class 2 response to its July 2017 Complete Response Letter with a PDUFA (Prescription Drug User Fee Act) target date of December 28, 2018 for the completion of the FDA’s review of the Dextenza NDA.

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

Dextenza is a corticosteroid intracanalicular insert placed through the punctum, a natural opening in the eye lid, into the canaliculus and is designed to deliver dexamethasone to the ocular surface for up to 30 days without preservatives. Following treatment, Dextenza is intended to resorb and exit the nasolacrimal system without the need for removal. Dextenza has completed phase 3 evaluation for the treatment of ocular pain and inflammation following ophthalmic surgery.

Upon approval for pain, the company intends to submit an NDA supplement for the treatment of inflammation following ocular surgery. Dextenza is also in phase 3 clinical development for allergic conjunctivitis.