Ocular Therapeutix announced FDA clearance of their dexamethasone punctum plug (Dextenza) for managing ocular pain after cataract surgery. The implant is the first intracanalicular drug delivery device.
Dextenza manages pain by dispelling 0.4 mg of preservative-free dexamethasone over a 30-day period. It is inserted through the lower lacrimal punctum into the canaliculus, where it is activated by moisture and swells to securely fit. The implant slowly reabsorbs during treatment and exits via the nasolacrimal, eliminating the need for surgical removal.
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.
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.