Recently, Ocular Therapeutix announced that the U.S. Food and Drug Administration (FDA) has approved its Supplemental New Drug Application (sNDA), expand the label of Dextenza (dexamethasone sustained-release punctal plug), and increase the treatment of allergic conjunctivitis-related ocular areas. New indications for itching.

Dextenza is a preservative-free lacrimal insert that releases the corticosteroid dexamethasone in a dose of 0.4 mg for up to 30 days. Because it is made of absorbable material, Dextenza is placed in one-time use without dismantling.

It is worth mentioning that Dextenza is the first small tube insert approved by the FDA. It can provide a preservative-free drug to treat eye itching related to allergic conjunctivitis. It can be released continuously after a single insertion. Semisone lasts up to 30 days.

Dextenza was originally approved in December 2018 for the treatment of eye pain after eye surgery. It was subsequently approved in June 2019 to expand the label range for the treatment of eye inflammation after eye surgery.

Allergic conjunctivitis is a common eye disease, and topical steroids are an important part of the clinical treatment of this disease. With the approval of the new indications, Dextenza will now bring patients a doctor-operated, preservative-free sustained-release steroid therapy to help treat the itchy eye associated with allergic conjunctivitis.

The efficacy and safety of Dextenza in the treatment of allergic conjunctivitis-related ocular itching have been confirmed in 3 randomized, multi-center, double-blind, parallel group, and vehicle-controlled studies. These studies included subjects who had a positive history of eye allergies and had a positive skin test for perennial and seasonal allergens (n=255).

In all three trials, Dextenza exhibited a low mean ocular itching score at all time points during the 30-day study period. In 2 of the 3 studies, compared with the vehicle group, the Dextenza treatment group had a higher proportion of patients with itchy eyes on day 8, 3, 5, and 7 minutes after the allergen challenge obviously decrease. The primary endpoint (Pruritus on Day 8) data for all 3 studies (0-4 points scale) are as follows:

It has been observed that Dextenza has good safety and is generally well tolerated in clinical populations with allergic conjunctivitis and ocular inflammation and pain.

In the pooled analysis of allergic conjunctivitis studies, the most common ocular adverse events were: increased intraocular pressure (3%), increased tearing (1%), ocular secretions (1%), and decreased vision (1%) . In patients using Dextenza for allergic conjunctivitis, the most common non-ocular adverse reaction was headache (1%).