FDA approves new indication for Dextenza
The U.S. Food and Drug Administration approved a Supplemental New Drug Application to extend Dextenza’s (dexamethasone ophthalmic insert; Ocular Therapeutix Inc) indication for the treatment of ocular itching associated with allergic conjunctivitis, according to a company press release.
This is the first approved intracanalicular insert used to deliver a preservative-free drug to treat ocular itching related to allergic conjunctivitis with a single administration for up to 30 days.
Dextenza was originally approved in November 2018 for the treatment of ocular pain following ophthalmic surgery. In June 2019, the label was expanded to include the treatment of ocular inflammation following ophthalmic surgery.
Approval was based on the 3 randomized, multicenter, double-masked, parallel group, vehicle-controlled studies evaluating the efficacy of Dextenza for the treatment of ocular itching associated with allergic conjunctivitis in 255 patients with a positive history of ocular allergies and positive skin test reaction to perennial and seasonal allergens. Compared with the vehicle group at all time points throughout the study, patients treated with Dextenza demonstrated lower mean ocular itching score in all 3 studies.
A statistically significant reduction in ocular itching on Day 8, at 3 minutes, 5 minutes, and 7 minutes post-challenge was demonstrated in the Dextenza group compared to the vehicle group in 2 out of 3 studies.
“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, Ophthalmology and Chief Medical Officer in the 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.”
Read the full press release here.