Tarsus Pharmaceuticals, Inc. has received FDA approval for XDEMVY (lotilaner ophthalmic solution) 0.25%, indicated for the treatment of Demodex blepharitis.
Tell me more about XDEMVY.
Developed under the name TP-03, XDEMVY (pronounced X-DEM-VEE) is a topical ophthalmic formulation of lotilaner 0.25% that targets and removes Demodex mite infestation—the root cause of Demodex blepharitis.
How does lotilaner work?
As the solution’s active ingredient, lotilaner works as an antiparasitic agent to target parasite-specific GABA-CI channels (located within the nervous system channels) to eliminate Demodex mites.
Gotcha. What’s the clinical data on it?
The approval is based on two randomized, multicenter, double-masked, vehicle-controlled pivotal trials—Saturn-1 (NCT04475432)and Saturn-2 (NCT04784091)—that found then-TP-03 to have a favorable safety profile and be well-tolerated.
In both trials, dosing was administered twice daily (BID) to a collective 833 patients (with 415 receiving TP-03) for 43 days; each met its primary endpoint and all secondary endpoints.
Any adverse events reported ?
Very minor, and either mild or moderate.
The most common adverse event (AE) reported in 10% of TP-03–treated patients was instillation site pain/burning/stinging.
Other AEs included chalazion/hordeolum (stye) and punctate keratitis, which occurred in just 2% of patients.
What’s the recommended dosage?
Per its prescribing information, one drop of XDEMVY 0.25% (2.5 mg/mL) should be instilled in each eye twice daily (approximately 12 hours apart) for 6 weeks.
See here for the full details.
With this approval, XDEMVY is now the first and only approved therapeutic that directly targets Demodex blepharitis.
Further, Tarsus initiated phase 2a Ersa exploratory trial in Summer 2022 to evaluate treatment of meibomian gland dysfunction (MGD) with Demodex mites.
The topline data readout is expected some time in the second half of 2023.
When will it be available?
According to Tarsus, the company expects to make XDEMVY available for eyecare providers (ECPs) to prescribe by the end of August 2023.