FDA Approves Xdemvy for Eye Infection Caused by Mites

The FDA has approved Xdemvy (lotilaner) to treat patients with Demodex blepharitis. Developed by Tarsus Pharmaceuticals, Xdemvy is the first FDA approved treatment to directly target inflammation that is caused by Demodex mites.

Blepharitis is a common disease of the eyelid that causes inflammation, redness and eye irritation. Demodex mites — parasites that mostly live in hair follicles and oil glands on the face, neck, or chest — can cause blepharitis. Demodex blepharitis impacts about 25 million eye care patients in the United States.

Xdemvy is an eye drop that is designed to eradicate the Demodex mites, which are too small to see with the naked eye. It is given as a single drop in each eye twice daily for six weeks. Xdemvy will be available by the end of August 2023 and will have a wholesale acquisition cost of $1,850 per prescription, the company said at an investor meeting. Executives said the pricing reflects the value the therapy provides.

Christopher Starr, M.D.

"Demodex blepharitis, easily diagnosed by the presence of eyelash collarettes, can result in ocular damage in multiple ways, including irritation, eyelash distention or loss and inflammation, which can be uncomfortable for patients. This new medicine is a positive step forward for the treatment of this disease in many patients who have been struggling for years," Christopher Starr, M.D., associate professor of ophthalmology, director of refractive surgery, Ophthalmic Education and the Cornea Fellowship Program at Weill Cornell Medicine, New York Presbyterian Hospital, said in a press release.

The approval was based on two studies (Saturn-1 and Saturn-2) designed to evaluate the safety and efficacy of Xdemvy in 833 patients, 415 of which received the treatment. Efficacy was demonstrated by an improvement in eyelids and included the reduction of collarettes, a condition that indicates the presence of mites. Collarette is a kind of dandruff that includes epithelial cells, mite waste and mite eggs. Some patients saw improvement as early as two weeks.

In clinical trials, Xdemvy was generally safe and well-tolerated. The most common ocular adverse reactions seen in the studies were eye stinging and burning, which was reported in 10% of patients. Other ocular adverse reactions reported in less than 2% of patients were chalazion/hordeolum (stye) and punctate keratitis (corneal inflammation).

This story first appeared on Managed Healthcare Executive.