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# FDA Approves Eyelid Mite Disease Drug
- URL: https://www.fdaweb.com/fda-approves-eyelid-mite-disease-drug/
- Published: 2023-07-25T12:00:00.000Z
- Updated: 2026-09-14T18:46:13.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5154943

FDA has approved a Tarsus Pharmaceuticals NDA for Xdemvy (lotilaner ophthalmic solution) 0.25% for treating *Demodex* blepharitis, an eyelid disease caused by *Demodex* mite infestation. It is characterized by redness, inflammation, missing or misdirected eyelashes, horizontal itching along the eyelid base and the presence of collarettes (waste products and eggs), according to the company, which adds that about 25 million in the U.S. are affected annually.

Approval is based on data from two randomized, multicenter, double-masked, vehicle-controlled studies (Saturn-1 and Saturn-2), which showed a “significant improvement in eyelids (reduction of collarettes, the pathognomonic sign of the disease, to no more than two collarettes per upper lid) in each study by Day 43, with some patients seeing improvement as early as two weeks,” Tarsus says. The most common ocular adverse reactions reported were instillation site stinging and burning (10% of patients), and chalazion/hordeolum (stye) and punctate keratitis, which were reported in less than 2% of patients, it says.