FDA approves Dextenza for treatment of postoperative ocular pain
The FDA approved Dextenza for intracanalicular use for the treatment of ocular pain after ophthalmic surgery, Ocular Therapeutix announced in a press release.
Dextenza (dexamethasone ophthalmic insert 0.4 mg) is the first FDA-approved intracanalicular insert to deliver dexamethasone to treat postoperative ocular pain for up to 30 days with one treatment.
“We are extremely pleased to announce the approval of Dextenza, coming so soon after our preapproval inspection and approximately 1 month ahead of the PDUFA date,” Antony Mattessich, Ocular Therapeutix president and CEO, said in the release.
Dextenza demonstrated efficacy in two randomized, vehicle-controlled phase 3 studies. A statistically significant number of patients who received Dextenza were free of pain 8 days after cataract surgery compared with patients in the vehicle control group. In addition, safety was demonstrated in the two phase 3 studies, as well as a third randomized, vehicle-controlled phase 2 study, the release said.
Ocular Therapeutix applied for transitional pass-through payment status and intends to apply for a J-code before the January 2019 deadline.