Dextenza Approved to Treat Pain Following Ophthalmic Surgery

December 3, 2018 – The U.S. FDA has approved Dextenza® (dexamethasone ophthalmic insert) 0.4mg, manufactured by Ocular Therapeutix, to treat ocular pain following ophthalmic surgery. The product is the first FDA-approved intracanalicular (placed in a small channel or duct) insert for drug delivery.

In clinical studies, 77-80% of patients treated with Dextenza were pain-free by Day 8 following cataract surgery, compared to 43-59% of patients in the vehicle-controlled group. Dextenza provides an alternative to corticosteroid eye drops, which may improve adherence for some patients. A qualified medical professional places the insert in the lacrimal punctum, a natural opening found in the inner eyelid, to reach the lacrimal duct. Once placed, Dextenza delivers dexamethasone, a corticosteroid, to the surface of the eye for up to 30 days. The single-use insert will dissolve on its own and does not need to be removed once exhausted.

Launch and pricing plans are not yet available.