Ocular Therapeutix launches Dextenza
Ocular Therapeutix is introducing Dextenza (dexamethasone ophthalmic insert) 0.4 mg for the treatment of ocular inflammation and pain following ophthalmic surgery.
Dextenza is the first Food and Drug Administration-approved intracanalicular insert, a drug product with a novel route of administration that enables the delivery of drug to the surface of the eye, obviating the need for a burdensome, monthly regimen of steroid eye drops, the company said.
Dextenza originally received FDA approval in November 2018 for the treatment of ocular pain following ophthalmic surgery.
The launch follows the June 21 announcement of FDA approval for Dextenza for the treatment of ocular inflammation following ophthalmic surgery. Dextenza now is the only sustained release steroid product approved for the treatment of both ocular inflammation and pain following ophthalmic surgery.
“We are extremely proud to be bringing Dextenza to market in the United States,” Ocular Therapeutix president and CEO Antony Mattessich said. “With reimbursement solidified through a unique C-code, the addition of inflammation to our label, and our direct, highly-experienced commercial team in place, we believe we are well-prepared for the launch of Dexenza. Dextenza represents a novel new treatment option that we believe offers significant value to both patients and physicians and we are excited for its potential in the market.”