Posted by Michael Wonder on 22 Jun 2019
Ocular Therapeutix announces FDA approval of supplemental new drug application for Dextenza (dexamethasone intracanalicular insert for ophthalmic use) for the treatment of ocular inflammation following ophthalmic surgery
21 June 2019 - Dextenza now approved for the treatment of ocular inflammation and pain following ophthalmic surgery.
Ocular Therapeutix today announced the U.S. FDA approved a supplemental new drug application (sNDA) for Dextenza to include the treatment of ocular inflammation following ophthalmic surgery as an additional indication. With the approval of the sNDA, Dextenza is now approved for the treatment of both ocular inflammation and pain following ophthalmic surgery.
The approval of the sNDA is supported by three Phase 3 randomised, vehicle-controlled trials; patients received Dextenza or a vehicle immediately upon completion of cataract surgery.
