Ocular Therapeutix™ Announces FDA Approval of Supplemental New Drug Application (sNDA) for DEXTENZA®

Ocular Therapeutics (NASDAQ:OCUL) has announced that the US Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) for DEXTENZA to include treatment of ocular inflammation after opthalmic surgery as an indication.

As quoted in the press release:

With the approval of the sNDA, DEXTENZA is now approved for the treatment of both ocular inflammation and pain following ophthalmic surgery.

DEXTENZA is the first FDA-approved intracanalicular insert, a novel route of administration that delivers drug to the surface of the eye without the need for eye drops. DEXTENZA is a preservative-free, resorbable hydrogel insert that delivers 0.4mg of dexamethasone to treat post-surgical ocular inflammation and pain for up to 30 days with a single administration. DEXTENZA originally received FDA approval in November 2018 for the treatment of ocular pain following ophthalmic surgery.

“We could not be more excited about both the approval and its earlier-than-expected timing,” said Antony Mattessich, the Company’s President and Chief Executive Officer. “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.”

Click here to read the full press release.