FDA approves new indication for Ocular Therapeutix’s Dextenza

The FDA has approved the use of Ocular Therapeutix’s physician-administered intracanalicular insert Dextenza (dexamethasone 0.4 mg) for the treatment of allergic conjunctivitis.

Dextenza’s history

Dextenza was originally approved to treat ocular pain and inflammation following ophthalmic surgery in November 2018. On October 11, 2021, the FDA approved a supplemental New Drug Application for an expanded indication to its label to including the treatment of ocular itching caused by allergic conjunctivitis.

The new indication’s approval 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.

Outcomes

Dextenza was well-tolerated and had a favorable safety profile and lower mean ocular itching scores in patients with allergic conjunctivitis at all times throughout the study duration of up to 30 days, according to the company. A pooled analysis of the studies revealed the most common ocular adverse events were increased intraocular pressure (3%), increased lacrimation (1%), eye discharge (1%), visual acuity reduction (1%), and headaches (1%).¹

References

1. Ocular Therapeutix announces FDA approval of supplemental new drug application (sNDA) for Dextenza (Dexamethasone Opthalmic Insert) 0.4 mg for intracanalicular use for the treatment of ocular itching associated with allergic conjunctivitis. Ocular Therapeutix. October 11, 2021. Accessed October 11, 2021. https://ocutx.gcs-web.com/news-releases/news-release-details/ocular-therapeutixtm-announces-fda-approval-supplemental-new-0