Ocular Therapeutix
(NSDQ:OCUL) said today that the FDA has approved a supplemental NDA for its dexamethasone ocular insert, Dextenza.
The Bedford, Mass.-based company requested in January that the U.S. regulatory agency expand the current indication for Dextenza to include the treatment of ocular inflammation following eye surgery.
Dextenza is designed to deliver drugs for up to 30 days following treatment in a physician’s office. The company’s drug-delivery device was approved in November for the treatment of pain following eye surgery.
“We could not be more excited about both the approval and its earlier-than-expected timing,” Ocular Therapeutix president and CEO Antony Mattessich said in a news release. “With our C-Code and pass-through payment status effective on July 1, the expanded indication gives us tremendous momentum as we approach our commercial launch.”
OCUL shares were up 3.15% this morning to $4.26 in active trading.
