Ocular Therapeutix got approval of Dextenza for the treatment of ocular pain for up to 30 days following ophthalmic surgery. (Ocular Therapeutix)
After twice being sidelined by manufacturing-related CRLs, Ocular Therapeutix got FDA approval on Monday for its first eye drug. The FDA nod came a month ahead of its latest PDUFA date after the eye specialist assembled a team to help it surmount FDA concerns over its production.
The agency approved Dextenza for the treatment of ocular pain following ophthalmic surgery. Dextenza is not only Ocular’s first drug but the first intracanalicular insert to be approved. It delivers the steroid dexamethasone for relief of pain for up to 30 days.