Thursday, July 27, 2023
LianBio's partner, Tarsus Pharmaceuticals, has received approval from the U.S. Food and Drug Administration (FDA) for XDEMVY™ (lotilaner ophthalmic solution) 0.25%.
XDEMVY is the first and only FDA-approved treatment specifically targeting Demodex mites, making it a significant milestone in addressing this condition.
XDEMVY, previously known as TP-03, is a novel prescription eye drop designed to treat Demodex blepharitis by directly targeting and eradicating the Demodex mite infestation, which is the root cause of the disease.
The approval of XDEMVY was based on the positive results from two pivotal trials conducted in the United States, which involved over 800 patients collectively. Both trials successfully met their primary endpoint and all secondary endpoints with statistical significance. Furthermore, there were no serious treatment-related adverse events reported during the trials.
The active ingredient in XDEMVY is lotilaner, a well-characterised agent known for its ability to selectively inhibit the GABA-Cl channels in Demodex mites, leading to their eradication. Additionally, lotilaner is highly lipophilic, which means it can readily be taken up in the oily sebum of the eyelash follicles where the mites reside.
With the approval of XDEMVY, patients suffering from Demodex blepharitis now have a targeted treatment option that aims to directly combat the Demodex mite infestation responsible for the condition.