The FDA approved Ocular Therapeutix Inc.’s Supplemental New Drug Application (sNDA) that further extends Dextenza’s (dexamethasone ophthalmic insert) 0.4 mg indications, the company announced Monday.
On October 11, 2021, the FDA approved the Ocular Therapeutix Inc.’s Supplemental New Drug Application that further extends Dextenza’s (dexamethasone ophthalmic insert) 0.4 mg indications. The drug can now be used intracanalicularly to treat ocular itching that is associated with allergic conjunctivitis.
This approval was announced a week ahead of the planned announcement.
Dextenza is the first, FDA-approved, physician-administered intracanalicular insert that delivers a preservative-free drug to treat ocular itching associated with allergic conjunctivitis with 1 administration lasting up to 30 days.
In commenting on the FDA approval, Michael Goldstein, MD, President, Ophthalmology and Chief Medical Officer, stated in a press release, “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. 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.”
In November 2018, Dextenza originally was approved to treat ocular pain after ophthalmic surgery. That later was followed in June 2019 by approval to treat ocular inflammation after ophthalmic surgery.
The current approval of the drug to treat ocular itching associated with allergic conjunctivitis was based on the results of 3 randomized, multicenter, vehicle-controlled studies that included 255 patients with a positive history of ocular allergies and positive skin test reaction to perennial and seasonal allergens.
The results of the 3 studies showed that Dextenza had lower mean ocular itching scores compared with the vehicle group at all time points throughout the study duration of up to 30 days. In 2 of the studies, higher percentages of patients had significant reductions in ocular itching on day 8 after the start of treatment, at 3, 5, and 7 minutes post-challenge in the Dextenza group compared to the vehicle group.