The FDA’s approval was based on the findings of Saturn-1 and Saturn-2 trials in which XDEMVY showed considerable improvement in eyelids by day 43, with some patients seeing improvement as early as two weeks
FDA clears Tarsus’ Xdemvy. (Credit: Marc Schulte on Unsplash)
Tarsus Pharmaceuticals has secured approval from the US Food and Drug Administration (FDA) for its Xdemvy (lotilaner ophthalmic solution) 0.25% to treat Demodex blepharitis.
Demodex blepharitis is a condition that manifests with several distinctive features. These include redness and inflammation of the eyelids, as well as the occurrence of missing or misdirected eyelashes. Patients may experience horizontal itching along the base of the eyelids, which can be bothersome and uncomfortable.
Another characteristic sign of Demodex blepharitis is the presence of collarettes, which are small cylindrical dandruff-like structures at the base of the eyelashes.
XDEMVY 0.25%, formerly known as TP-03, is a prescription eye drop. It is designed to treat Demodex blepharitis by targeting and removing Demodex mite infestation, the root cause of the disease.
The FDA gave its approval based on the findings of Saturn-1 and Saturn-2 trials.
Each study’s efficacy was shown by a considerable improvement in eyelids by day 43, with some patients seeing improvement as early as two weeks.
Additionally, day 43 results from both studies demonstrated statistically significant improvement in the endpoints of mite eradication and erythema cure. Xdemvy was generally safe and well tolerated during clinical trials.
The trials found that 10% of patients had stinging and burning at the injection site, which was the most typical ocular adverse event.
Tarsus CEO and chairman Bobak Azamian said: “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.
“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 honoured for the opportunity to introduce the first and only approved therapeutic for this disease to the eye care community.”
Both Saturn-1 and Saturn-2 trials were randomised, multicentre, double-masked, vehicle-controlled and intended to assess the safety and effectiveness of Xdemvy in 833 patients, out of which 415 were given Xdemvy.
Over the course of six weeks, patients with Demodex blepharitis were randomised to receive either Xdemvy or a vehicle at a 1:1 ratio, twice daily, in each eye.
The Demodex blepharitis therapy is expected to be available by prescription by the end of August 2023.