After FDA approval, XDEMVY is available for prescription nationwide to target Demodex mites, the primary cause of the external eye disease Demodex blepharitis.
The FDA approved XDEMVY (lotilaner ophthalmic solution, Tarsus Pharmaceuticals) 0.25% to treat demodex blepharitis, an external eye disease, on July 25, 2023. The treatment specifically targets Demodex mites, which are the primary cause of Demodex blepharitis.
About 25 million eye care patients, or 1 in 12 adults, are affected by Demodex blepharitis, which is caused by an infestation of Demodex mites, most commonly found on the human skin. Although it is common, it is often misdiagnosed or underdiagnosed. The disease is characterized by redness, missing or misdirected eyelashes, presence of collarettes, horizontal itching in the eyelid base, and inflammation.
“More than half of the patients in my practice present with Demodex blepharitis…Many patients have experienced redness, crusting, and overall ocular discomfort for years and I am excited to finally be able to offer an FDA-approved treatment for my patients,” said Selina McGee, OD, FAAO, of BeSpoke Vision in a press release.1
XDEMVY is the only treatment that targets Demodex mites that has been approved by the FDA. The treatment, previously known as TP-03, was given approval based on data from 2 randomized, multicenter, double-masked, vehicle-controlled studies: Saturn-1 and Saturn-2.
“This tremendous milestone was achieved through a successful collaboration of our talented Tarsus team, countless eye care providers, and the hundreds of patients who participated in our trials,” said Bobak Azamian, MD, PhD, CEO and chairman of Tarsus Pharmaceuticals Inc, in the press release.
There were 833 patients in the 2 studies, of which 415 received the treatment. All patients with Demodex blepharitis were randomized in a 1:1 ratio to XDEMVY and the vehicle groups, and all participants were given the treatment twice daily.
Significant improvement in eyelids by day 43, through reduction of collarettes to no more than 2 collarettes per upper lid, was deemed as the demonstration of efficacy. Statistically significant improvement in mite eradication and erythema cure was shown on day 43 in both studies as well. Adverse effects of the treatment included instillation site stinging and burning, which was reported in 10% of patients. Less than 2% of patients reported styes and punctate keratitis.
XDEMVY became available at pharmacies across the United States on August 24, 2023. The current prescription will allow patients to administer 1 drop per eye twice a day for 6 weeks. Soft contact lenses should be removed when taking this treatment, as the contents of XDEMVY could lead to contact discoloration. Lenses should not be inserted until 15 minutes after administration of the eye drops.2
1. FDA approves XDEMVY (lotilaner ophthalmic solution) 0.25% for the treatment of Demodex blepharitis. News release. Tarsus. July 25, 2023. Accessed September 26, 2023. https://ir.tarsusrx.com/news-releases/news-release-details/fda-approves-xdemvytm-lotilaner-ophthalmic-solution-025
2. Kaiser Maharjan E. Tarsus announces Xdemvy availability at pharmacies nationwide. Optometry Times. August 24, 2023. Accessed September 26, 2023. https://www.optometrytimes.com/view/tarsus-announces-xdemvy-availability-at-pharmacies-nationwide