3 December 2018 - Dextenza (dexamethasone ophthalmic insert) is the first intra-canalicular insert for drug delivery.

Ocular Therapeutix today announced that the U.S. FDA has approved Dextenza (dexamethasone ophthalmic insert) 0.4mg for intra-canalicular use for the treatment of ocular pain following ophthalmic surgery.

The approval of Dextenza was based on (i) demonstrated efficacy in two randomised, vehicle-controlled Phase 3 studies in which a statistically significantly higher incidence of subjects were pain free at day 8 post-cataract surgery compared to the vehicle control group and (ii) safety in the two Phase 3 studies as well as a third randomised, vehicle-controlled Phase 2 study.

Read Ocular Therapeutix press release