Yesterday, the U.S. Food and Drug Administration (FDA) granted revolutionary hope for sufferers of Demodex blepharitis with the approval of XDEMVY™ (lotlilaner ophthalmic solution) 0.25%. XDEMVY, formerly known as TP-03, is the only FDA approved treatment that directly targets Demodex mites – the root cause of Demodex blepharitis. In an unprecedented move, LianBio’s (Nasdaq: LIAN) partner, Tarsus Pharmaceuticals (Tarsus), has provided much needed relief for those affected by the condition.
LianBio is actively pursuing the development and commercialization of TP-03 for Demodex blepharitis and Meibomian Gland Disease in Mainland China, Hong Kong, Macau and Taiwan. The LIBRA trial, a phase 3 multicenter registrational study, designed to evaluate the efficacy and safety of TP-03 in Chinese adult patients with Demodex blepharitis is up and running! This double-blind, randomized, vehicle-controlled study recently concluded 163 participant enrollment in June 2023.
The primary outcome endpoints are collarette score of 0 and mite density of 0 mites per lash at day 43, while secondary endpoints include a composite cure of collarette and erythema (collarette score of 0 and erythema score of 0) at day 43. Topline results of LIBRA are expected to be reported in fourth quarter of 2023.
We are thrilled to congratulate Tarsus on receiving U.S. FDA approval of XDEMVY for the treatment of Demodex blepharitis, a condition that affects 43 million people in China. This makes XDEMVY the only approved drug targeting the root cause of this often burdensome and uncomfortable disease. As we look forward to concluding our LIBRA study in 2021, with positive results, we will be in a position to submit a New Drug Application to support regulatory approval in China.
About Demodex Blepharitis
Blepharitis, a condition affecting the eyelids, is a common problem that affects millions of people, particularly in China, due to its link with the ectoparasite Demodex mites. The resulting inflammation, redness and ocular irritation not only cause discomfort, but can significantly impact the quality of life.
Demodex blepharitis, known to be the most common form of eyelid margin disease, is caused by the infestation of these mites and could be affecting approximately 40 million people around the world.
XDEMVY, the revolutionary prescription eye drop formerly known as TP-03, has been specifically designed to target and eradicate the root cause of Demodex blepharitis: Demodex mite infestation. The active ingredient in XDEMVY, lotilaner ophthalmic solution 0.25%, is a highly lipophilic molecule that is selectively effective in inhibiting the mite’s GABA-Cl channels and eradicating the mites from the oily sebum of the eye lash follicles.
In two pivotal clinical trials conducted by Tarsus Pharmaceuticals and involving more than 800 patients, XDEMVY proved to be beneficial in meeting the primary and secondary endpoints with no serious side effects.
Most patients reported that using the eye drop was comfortable, with instillation site stinging and burning being the most common ocular adverse reaction (10% of patients). Chalazion/hordeolum (stye) and punctate keratitis were other rare side effects reported by less than 2%.
LianBio is a pioneering biotechnology company striving to bring novel, life-saving medicines to disadvantaged patients in China and beyond. Through collaborations with cutting-edge global biopharmaceutical firms, the firm is developing a multifarious range of therapeutics targeting cardiovascular, oncology, ophthalmology, and inflammatory disease cases.
With its far-reaching international framework, LianBio is emerging as a favored partner for those aiming to access the Chinese and Asian markets. Unlocking the potential of modern medicine for patients who need it most, LianBio is striving to redefine how healthcare is delivered.