FDA approves Xdemvy for treatment of Demodex blepharitis

The U.S. Food and Drug Administration (FDA) approved Xdemvy (lotilaner ophthalmic solution; Tarsus Pharmaceuticals) 0.25% for the treatment of Demodex blepharitis. XDEMVY, formerly known as TP-03, is the first and only FDA-approved treatment to directly target Demodex mites, the root cause of Demodex blepharitis.

The FDA approval was based on the findings of 2 clinical trials, Saturn-1 and Saturn-2, which were designed to evaluate the safety and effectiveness of the medication in treating Demodex blepharitis. A total of 833 patients with Demodex blepharitis were randomly assigned to receive Xdemvy (n = 415) or placebo, twice daily in each eye for 6 weeks.

Efficacy was demonstrated by a significant improvement in eyelids, specifically a reduction of collarettes (the characteristic sign of Demodex blepharitis) to no more than 2 collarettes per upper lid by Day 43. Some patients even experienced improvement as early as 2 weeks into the treatment. Moreover, mite eradication (reducing mite density to 0 mites per lash) and erythema cure (Grade 0) showed statistically significant improvement at Day 43 across both studies.

Xdemvy was generally well tolerated, with the most common ocular adverse reactions of 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.

Read the full press release here.