FDA Approves XDEMVY (lotilaner ophthalmic solution) 0.25% for the treatment of Demodex blepharitis

XDEMVY is the first and only approved therapeutic for Demodex blepharitis, a highly prevalent eyelid disease that impacts approximately 25 million eye care patients in the U.S.

XDEMVY targets the root cause of Demodex blepharitis and has demonstrated efficacy across multiple clinical measures of disease

XDEMVY expected to be available by prescription by the end of August 2023

Tarsus will host a webcast on July 25, 2023 at 5:30am PT / 8:30am ET

IRVINE, Calif., July 25, 2023 (GLOBE NEWSWIRE) -- Tarsus Pharmaceuticals, Inc. (NASDAQ: TARS), whose mission is to focus on unmet needs and apply proven science and new technology to revolutionize treatment for patients, starting with eye care, today announced that the U.S. Food and Drug Administration (FDA) approved XDEMVY (lotilaner ophthalmic solution) 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.

“We are thrilled to announce the FDA approval of XDEMVY for the treatment of Demodex blepharitis and look forward to making this product broadly available to the millions of patients who have not had any FDA approved therapeutics for this disease,” said Bobak Azamian, MD, PhD, Chief Executive Officer and Chairman of Tarsus. “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. We are grateful and honored for the opportunity to introduce the first and only approved therapeutic for this disease to the eye care community.”

The FDA approval is based on results from two randomized, multicenter, double-masked, vehicle-controlled studies (Saturn-1 and Saturn-2), designed to evaluate the safety and efficacy of XDEMVY in 833 patients, 415 of which received XDEMVY. Patients with Demodex blepharitis were randomized to either XDEMVY or vehicle at a 1:1 ratio and dosed twice daily in each eye over the course of 6 weeks.

Efficacy was demonstrated by a significant improvement in eyelids (reduction of collarettes, the pathognomonic sign of the disease, to no more than 2 collarettes per upper lid) in each study by Day 43, with some patients seeing improvement as early as 2 weeks. Additionally, the endpoints of mite eradication (mite density of 0 mites per lash) and erythema cure (Grade 0) showed statistically significant improvement at Day 43 across both studies. In clinical trials, XDEMVY was generally safe and well tolerated. The most common ocular adverse reactions observed in the studies were instillation site 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.