Expanded Indication for Dextenza
June 20, 2019 – The U.S. FDA has approved an expanded indication for Dextenza® (dexamethasone ophthalmic insert) 0.4mg, manufactured by Ocular Therapeutix. It is now approved to treat ocular pain and inflammation following ophthalmic surgery, such as cataract removal.
Dextenza is the first FDA-approved intracanalicular insert, a novel route of administration that delivers a corticosteroid to the surface of the eye without the need for eye drops. The resorbable hydrogel insert delivers 0.4mg of dexamethasone directly to the eye for up to 30 days with a single administration. In clinical trials, a higher proportion of patients treated with Dextenza were pain free by the eighth day following ocular surgery compared to those who were treated via a different route of administration.
Following surgery, the ophthalmic surgeon places Dextenza into a small channel in the tear duct. The product will then release dexamethasone over the course of 30 days. Dextenza is designed to dissolve on its own, but can be removed sooner if needed. It was first approved in 2018 to treat ocular pain—but not inflammation—following ophthalmic surgery.