The Bedford, Mass.-based company requested 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.
Ocular Therapeutix said it expects the FDA will finish reviewing its sNDA in the second half of 2019.
“Submission of this sNDA on the heels of the initial Dextenza approval is another significant milestone for Ocular Therapeutix. The potential market opportunity for postoperative ocular pain and inflammation is substantial and there remains an important unmet need to address the issue of non-compliance given currently available treatment options,” president & CEO Antony Mattessich said in prepared remarks. “This is another major step toward our goal of making eye-drop therapies obsolete.”
OCUL shares closed yesterday at $4.00 apiece, down -3.6%.