FDA Approves Lotilaner Ophthalmic Solution for Treatment of Demodex Blepharitis

US Food and Drug Administration (FDA)

The US Food and Drug Administration (FDA) has approved lotilaner ophthalmology solution 0.25% (XDEMVY™), formerly known as TP-03, for the treatment of Demodex blepharitis.¹

Announced in a news release by Tarsus Pharmaceuticals Inc., the ophthalmic solution is the first-and-only FDA-approved treatment to directly target Demodex mites, the root cause of the common, yet often underdiagnosed eyelid disease.

“After years of seeing Demodex blepharitis in my practice without an effective way to target the root cause of the disease, I’m so pleased to have a new treatment to offer my patients,” Christopher Starr, MD, associate professor of ophthalmology and director of refractive surgery, ophthalmic education, and the cornea fellowship program at Weill Cornell Medicine, New York Presbyterian Hospital, said in a statement. “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.”

Approval of lotilaner ophthalmology solution 0.25% was based on results from 2 randomized, multicenter, double-masked, vehicle-controlled studies (Saturn-1 and Saturn-2) designed to evaluate the safety and efficacy of the solution in 833 patients. Individuals with Demodex blepharitis were randomized to either the ophthalmic solution or vehicle at a 1:1 ratio and dosed twice daily in each eye over a 6-week period. A total of 415 patients received lotilaner ophthalmology solution 0.25% in the studies.

According to the release, efficacy was demonstrated by a significant improvement in eyelids, with a reduction of collarettes to ≤2 collarettes per upper lid, by Day 43 in each study. Some patients reportedly saw improvement as early as 2 weeks. The endpoint of mite eradication (mite density: 0 mites per lash) and erythema cure (Grade 0) also showed statistically significant improvement at Day 43 across both studies.

Safety outcomes in the clinical trials showed the ophthalmic solution was generally considered safe and well-tolerated. The most common ocular adverse reactions observed in the 2 studies were instillation site stinging and burning, reported in 10% of patients. Other ocular adverse reactions occurring in ≤2% of patients were chalazion/hordeolum and punctate keratitis.

Approximately 25 million eye care patients in the US are impacted by Demodex blepharitis, an eyelid disease caused by an infestation of Demodex mites, the most common ectoparasite found on human skin.² The eyelid disease is characterized by redness, inflammation, missing or misdirected eyelashes, horizontal itching along the eyelid base, and the presence of collarettes.

“More than half of the patients in my practice present with Demodex blepharitis, and to date, we’ve not had any FDA-approved therapies to treat the disease,” Selina McGee, OD, BeSPoke Vision, said in a statement.¹ “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.”

The news release indicated the company’s excitement in announcing the FDA approval of lotilaner ophthalmology solution 0.25% and making the product available to these millions of patients who previously had no FDA-approved therapeutics.

“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,” Bobak Azamian, MD, PhD, the chief executive officer, and chairman of Tarsus Pharmaceuticals, said in a statement. “We are grateful and honored for the opportunity to introduce the first-and-only approved therapeutic for this disease to the eye care community.”

References

1. FDA approves XDEMVYTM (Lotilaner Ophthalmic Solution) 0.25% for the treatment of demodex blepharitis. Tarsus Pharmaceuticals. July 25, 2023. Accessed July 25, 2023. https://ir.tarsusrx.com/news-releases/news-release-details/fda-approves-xdemvytm-lotilaner-ophthalmic-solution-025.
2. Trattler W, Karpecki P, Rapoport Y, et al. The Prevalence of Demodex Blepharitis in US Eye Care Clinic Patients as Determined by Collarettes: A Pathognomonic Sign. Clin Ophthalmol. 2022;16:1153-1164. Published 2022 Apr 15. doi:10.2147/OPTH.S354692