The Food and Drug Administration has approved the supplemental New Drug Application for Dextenza® (dexamethasone ophthalmic insert) for the treatment of ocular itching associated with allergic conjunctivitis.
The approval was based on data from 3 randomized, multicenter, double-masked, parallel group, vehicle-controlled phase 3 studies (ClinicalTrials.gov Identifier: NCT02445326, NCT02988882, NCT04050865) that evaluated the efficacy and safety of Dextenza in patients with a history of ocular allergies and positive skin test reaction to perennial and seasonal allergens.
Findings from all 3 trials demonstrated that treatment with Dextenza resulted in lower mean ocular itching scores compared with vehicle at all time points throughout the 30-day study duration. In 2 of the 3 studies, a higher proportion of patients in the Dextenza arm achieved statistically significant reductions in ocular itching on day 8, at 3 minutes, 5 minutes, and 7 minutes post challenge compared with patients in the vehicle arm.
The most common ocular adverse reactions reported with Dextenza included increased intraocular pressure (3%), increased lacrimation (1%), eye discharge (1%) and reduced visual acuity (1%). The most common nonocular adverse reaction was headache (1%).
“We are really excited about this label expansion and the potential benefits for patients,” said Michael Goldstein, MD, President, Ophthalmology and Chief Medical Officer, Ocular Therapeutix. “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.”
Dextenza is an intracanalicular insert that delivers 0.4mg of dexamethasone for up to 30 days following insertion. It is also approved to treat 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. Ocular Therapeutix, Inc. Accessed October 12, 2021. https://www.businesswire.com/news/home/20211011005575/en/Ocular-Therapeutix%E2%84%A2-Announces-FDA-Approval-of-Supplemental-New-Drug-Application-sNDA-for-DEXTENZA%C2%AE-dexamethasone-ophthalmic-insert-0.4-mg-for-Intracanalicular-Use-for-the-Treatment-of-Ocular-Itching-Associated-with-Allergic-Conjunctivitis.
- Dextenza. Package insert. Ocular Therapeutix, Inc.; 2021. Accessed October 12, 2021. https://www.dextenza.com/wp-content/uploads/DEXTENZA-Full-Prescribing-Information.pdf.