FDA Approves Dextenza for Use in Patients With Ocular Itching Associated With Allergic Conjunctivitis
Officials with the FDA have approved a supplemental new drug application to broaden the label for dexamethasone ophthalmic insert (Dextenza, Ocular Therapeutix) to add an additional indication for the treatment of ocular itching associated with allergic conjunctivitis. According to Ocular Therapeutix, Dextenza is now the first FDA-approved, physician-administered intracanalicular insert capable of delivering a preservative-free drug for the treatment of ocular itching associated with allergic conjunctivitis with a single administration for up to 30 days.
The approval is based on the results from 3 randomized, multicenter, double-masked, parallel group, vehicle-controlled studies. Dextenza demonstrated lower mean ocular itching scores compared with the vehicle group at all time points throughout the study duration of up to 30 days across all 3 trials.
“Allergic conjunctivitis is a common condition seen in the offices of eye care providers. We are really excited about this label expansion and the potential benefits for patients,” said Michael Goldstein, MD, president of ophthalmology and chief medical officer at Ocular Therapeutix, in a press release. “The use of topical steroids is an important part of our current clinical armamentarium in the treatment of allergic conjunctivitis. Dextenza can now provide an office-based, physician-administered, preservative-free method of steroid delivery that benefits patients with ocular itching associated with allergic conjunctivitis.”
According to the investigators, Dextenza was observed to have a favorable safety profile and be generally well-tolerated, with the most common ocular adverse events seen across all 3 studies including increased intraocular pressure, increased lacrimation, eye discharge, and reduced visual acuity.
Dextenza is a corticosteroid intracanalicular insert placed in the punctum—a natural opening in the inner portion of the lower eyelid—that delivers dexamethasone to the ocular surface for up to 30 days. It is also approved for the treatment of ocular inflammation and pain following ophthalmic surgery.
Ocular Therapeutix™ announces FDA approval of Supplemental New Drug Application (sNDA) for DEXTENZA® (dexamethasone ophthalmic insert) 0.4 mg for intracanalicular use for the treatment of ocular itching associated with allergic conjunctivitis [news release]. BusinessWire; October 11, 2021. Accessed October 12, 2021. https://www.businesswire.com/news/home/20211011005575/en