FDA nod for Xdemvy, first treatment for eyelid disease, Demodex blepharitis

The US Food and Drug Administration (FDA) yesterday approved Xdemvy (lotilaner ophthalmic solution) 0.25% for the treatment of Demodex blepharitis.

Developed by USA-based eye care specialist Tarsus Pharmaceuticals (Nasdaq: TARS), 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 Dr Bobak Azamian, chief executive and chairman of Tarsus, adding: “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.”