FDA Grants Approval to Tarsus’ Demodex Blepharitis Drug, Xdemvy

Image Credit: Adobe Stock Images/michnik101

Tarsus Pharmaceuticals has officially announced the FDA approval of Xdemvy, a treatment for Demodex blepharitis. Cleared as the first and only remedy for the eyelid disease, Xdemvy reportedly targets Demodex mites directly, the root cause of Demodex blepharitis.

In two randomized studies designed to assess Xdemby’s safety and effectiveness, 415 out of 833 patients received the medication two times a day over the course of six weeks. The FDA’s approval is based on results showing significant improvement in the patients’ eyelids.

“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, CEO, Chairman, 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.”

Reference: FDA Approves XDEMVY™ (lotilaner ophthalmic solution) 0.25% for the treatment of Demodex blepharitis. GlobeNewswire. July 25, 2023. Accessed July 26, 2023. https://www.globenewswire.com/news-release/2023/07/25/2710273/0/en/FDA-Approves-XDEMVY-lotilaner-ophthalmic-solution-0-25-for-the-treatment-of-Demodex-blepharitis.html