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US FDA Approves Xdemvy Eye Drops from Tarsus for Demodex Blepharitis
Author: Jennie Crabbe
Tarsus Pharmaceuticals announced July 25 that the US FDA had approved Xdemvy (lotilaner ophthalmic solution) 0.25% for the treatment of Demodex blepharitis.
Xdemvy, formerly known as TP-03, is the first FDA-approved treatment to directly target Demodex mites.
Approval was based on positive results from two pivotal trials (Saturn-1 and Saturn-2) collectively involving more than 800 patients in which TP-03 met all endpoints and was well-tolerated.
The most common ocular adverse reactions observed in the studies were instillation site stinging and burning, reported in 10 percent of patients. Other adverse events reported by less than 2 percent of patients were chalazion/hordeolum (stye) and punctate keratitis.
Demodex mites are the most common ectoparasite found on human skin. Demodex blepharitis is characterized by redness, inflammation, missing or misdirected eyelashes, itching along the eyelid base, and the presence of collarettes—cylindrical, waxy debris of mite waste products and eggs found at the base of the eyelashes.
Xdemvy is a potent, non-competitive antagonist of insect and arachnid GABA-Cl channels. It is highly lipophilic, which appears to promote its uptake in the oily sebum of the hair follicle where Demodex mites reside.
Tarsus, of Irvine, California, said it expects that Xdemvy will be available by prescription by the end of August.
Each Xdemvy prescription will have a list price of $1,850, with the prescription expected to last one year.
Tarsus said it will launch an assistance program to keep the cost to patients at $100 or less until Xdemvy is covered by commercial insurers, expected in 2024, and by Medicare Part D, expected in 2025.
The company is also advancing the formulation for the treatment of meibomian gland dysfunction in Demodex patients.
China’s LianBio paid Tarsus $15 million up front in March 2021 to license TP-03 for the Greater China market. Tarsus was also set to receive up to $185 million in development and commercialization milestone payments. LianBio is conducting a Phase III trial of TP-03 in China, and expects to report topline results in Q4-2023.
