Dextenza Approved for Ocular Pain Following Ophthalmic Surgery

First FDA-approved intracanalicular insert for drug delivery.
First FDA-approved intracanalicular insert for drug delivery.

The Food and Drug Administration (FDA) has approved Dextenza (dexamethasone ophthalmic insert; Ocular Therapeutix) for the treatment of ocular pain following ophthalmic surgery.

Dextenza is an intracanalicular insert that delivers a 0.4mg dose of dexamethasone, a corticosteroid, for up to 30 days following insertion. The approval was based on data from 2 vehicle-controlled Phase 3 trials. In both studies, Dextenza was associated with a higher incidence of pain-free patients at all post-operative days (Day 2, 4, 8) compared with vehicle. At Day 8, 80% and 77% of Dextenza-treated patients were pain free vs 43% and 59% for vehicle in Studies 1 and 2, respectively. 

The most common adverse events associated with therapy included anterior chamber inflammation and elevations in intraocular pressure (occurred in approximately 5-9% of patients).

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Dextenza is supplied as a resorbable ophthalmic intracanalicular insert containing a 0.4mg dose of dexamethasone; it is intended for single dose only and does not require removal.

"Compliance with taking eye drops after eye surgery is very challenging for patients and a concern for surgeons," said Michael Goldstein, MD, Chief Medical Officer. "The approval of Dextenza offers surgeons the opportunity to treat patients with a preservative-free steroid after surgery with the placement of a single drug insert."

For more information visit Dextenza.com.