FDA Approves Tarsus Pharmaceuticals’ XDEMVY for Treatment of Demodex Blepharitis

Tarsus Pharmaceuticals has received FDA approval for XDEMVY(TM) (lotilaner ophthalmic solution) 0.25% to treat Demodex blepharitis, making it the first and only FDA-approved treatment directly targeting Demodex mites, the underlying cause of the condition.

The approval was based on the positive outcomes of two randomized, multicenter, double-masked, vehicle-controlled studies (Saturn-1 and Saturn-2), which involved 833 patients, with 415 of them receiving XDEMVY.

During the 6-week course of treatment, patients with Demodex blepharitis were randomized to receive either XDEMVY or the vehicle at a 1:1 ratio, with twice-daily dosing in both eyes. Results from both studies showed significant improvement in eyelids, evidenced by a reduction of collarettes (the disease's characteristic sign) to no more than 2 collarettes per upper lid by Day 43.

Some patients experienced improvements as early as 2 weeks. Additionally, Day 43 outcomes revealed statistically significant improvement in mite eradication (0 mites per lash) and erythema cure (Grade 0) across both studies.

Clinical trials demonstrated that XDEMVY was generally safe and well-tolerated. The most common ocular adverse reactions reported in the studies were instillation site stinging and burning, which affected 10% of patients. Other ocular adverse reactions, such as chalazion/hordeolum (stye) and punctate keratitis, were reported in less than 2% of patients.