Ocular Therapeutix announced the FDA approved a supplemental new drug application (NDA) for Dextenza to include the treatment of ocular inflammation following ophthalmic surgery as an additional indication. With the approval of the supplemental NDA, Dextenza is now approved for the treatment of both ocular inflammation and pain following ophthalmic surgery.
Dextenza is the first FDA-approved intracanalicular insert, a novel route of administration that delivers drug to the surface of the eye without the need for eye drops. Dextenza is a preservative-free, resorbable hydrogel insert that delivers 0.4 mg of dexamethasone to treat post-surgical ocular inflammation and pain for up to 30 days with a single administration. Dextenza originally received FDA approval in November 2018 for the treatment of ocular pain following ophthalmic surgery.
“We could not be more excited about both the approval and its earlier-than-expected timing,” Antony Mattessich, the company’s President and Chief Executive Officer, said in a company news release. “With our C-Code and pass-through payment status effective on July 1, the expanded indication gives us tremendous momentum as we approach our commercial launch.”
The approval of the supplemental NDA is supported by three phase 3 randomized, vehicle-controlled trials. Patients received Dextenza or a vehicle immediately upon completion of cataract surgery. In all three trials, Dextenza had, at a statistically significant level, a higher proportion of patients than the vehicle group who were pain free on postoperative Day 8. On postoperative Day 14, in two of the three studies, Dextenza had a higher proportion of patients than the vehicle group, at a statistically significant level, who had an absence of anterior chamber cells.