LianBio Partner Tarsus Pharmaceuticals Announces U.S. FDA Approval of XDEMVY (lotilaner ophthalmic solution) 0.25% for the Treatment of Demodex Blepharitis

LianBio’s partner, Tarsus Pharmaceuticals (Tarsus), announced yesterday that the U.S. Food and Drug Administration (FDA) approved XDEMVY (lotlilaner 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.

LianBio in-licensed rights from Tarsus for the development and commercialization of TP-03 for Demodex blepharitis and Meibomian Gland Disease in Mainland China, Hong Kong, Macau and Taiwan. LianBio is currently conducting the LIBRA trial, a Phase 3 multicenter, double-blind, randomized, vehicle-controlled registrational study designed to evaluate the efficacy and safety of TP-03 in Chinese adult patients with Demodex blepharitis, with an open-label pharmacokinetics sub-study. LIBRA completed enrollment of 163 patients in June 2023. The co-primary endpoints are complete collarette cure (collarette score of 0) and mite eradication (mite density of 0 mites per lash) at day 43. Secondary endpoints include composite cure of collarette and erythema (collarette score of 0 and erythema score of 0) at day 43. LianBio expects to report topline results from LIBRA in the fourth quarter of 2023.

“We congratulate Tarsus on receiving U.S. FDA approval of XDEMVY for the treatment of Demodex blepharitis,” said Yizhe Wang, Ph.D., Chief Executive Officer of LianBio. “XDEMVY is the only approved drug in the United States that targets the root cause of Demodex blepharitis, a disease that impacts an estimated 43 million patients in China. We look forward to concluding our LIBRA study this year, and if the data are positive, submitting a New Drug Application to support regulatory approval in China.”