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FDA Approves Novel Ocular Drug Delivery Device

December 4, 2018

On December 3, 2018, Ocular Therapeutix Inc. announced that the Food and Drug Administration (FDA) approved Dextenza (dexamethasone ophthalmic insert) for the treatment of ocular pain following ophthalmic surgery.

Dextenza is a novel intracanalicular hydrogel insert that delivers dexamethasone 0.4 mg in sustained and tapered release over 30 days. It is placed by a physician into the operative eye following surgery, where it resides in the canaliculus. The single-use insert does not require removal, it is designed to dissolve after remaining in the eye for approximately 30 days and it is cleared through the nasolacrimal duct.

Ocular Therapeutix plans to commercially launch Dextenza during the third quarter of 2019.

 

BusinessWire. Ocular Therapeutix™ Announces FDA Approval of Dextenza® for the Treatment of Ocular Pain Following Ophthalmic Surgery [news release]. December 3, 2018. Available at: click here. Accessed December 3, 2018.