Inserts replace steroid eyedrops.
Ocular Therapeutix announced today that the FDA has broadened the approval of its dexamethasone ophthalmic inserts to include an indication for treatment of ocular itching associated with allergic conjunctivitis.
The inserts, sold under the brand name Dextenza, were originally approved in November 2018 as a treatment for ocular pain after ophthalmic surgery with treatment for post-surgical ocular inflammation added as an indication in June 2019.
“It is hard to overstate the strategic importance of this label expansion for Ocular Therapeutix,” Antony Mattessich, president and CEO of the Bedford, Massachusetts, company said in the press release about the latest indication. “Allergic conjunctivitis, as our first in-office indication, lays the foundation for the rest of our pipeline.”
The company’s stock price rose 15.38% today, closing at $11.15.
The company’s inserts are designed to gradually release a tapered dose of dexamethasone, a common antiinflammatory steroid, to the surface of the eye over a period of 30 days. The inserts fit into the eye’s lower canaliculus, a tiny duct in the inside corner of the eye, and get resorbed so don’t need to be removed. The inserts are a replacement for steroid eyedrops.
Formally, the action that the FDA was approval of a supplemental New Drug Application (sNDA) to broaden Dextenza’s FDA-approved label to add an additional indication for the treatment of ocular itching associated with allergic conjunctivitis. The press release says the FDA OK makes Dextenza the first, FDA-approved, physician-administered intracanalicular insert capable of delivering a preservative-free drug for the treatment of ocular itching.