Profile
General Information
Xdemvy (lotilaner ophthalmic solution) is an ectoparasiticide (anti-parasitic) agent.
Xdemvy is specifically indicated for the treatment of Demodex blepharitis.
Xdemvy is supplied as a solution for topical administration. Instill one drop of Xdemvy in each eye twice daily (approximately 12 hours apart) for 6 weeks. If more than one topical ophthalmic drug is being used, the drugs should be administered at least five (5) minutes apart. If one dose is missed, treatment should continue with the next scheduled dose
Mechanism of Action
Lotilaner is a gamma-aminobutyric acid (GABA)-gated chloride channel inhibitor selective for mites. Inhibition of these GABA chloride channels causes a paralytic action in the target organism leading to its death. Lotilaner is not an inhibitor of mammalian GABA mediated chloride channels when tested at up to 30 µM (18 µg/mL) in vitro (approximately 1100 times the RHOD).
Side Effects
Adverse effects associated with the use of Xdemvy may include, but are not limited to, the following:
- instillation site stinging
- burning
Clinical Trial Results
The FDA approval is based on results from two randomized, multicenter, double-masked, vehicle-controlled studies (Saturn-1 and Saturn-2), designed to evaluate the safety and efficacy of Xdemvy in 833 patients, 415 of which received Xdemvy. Patients with Demodex blepharitis were randomized to either Xdemvy or vehicle at a 1:1 ratio and dosed twice daily in each eye over the course of 6 weeks.
Efficacy was demonstrated by a significant improvement in eyelids (reduction of collarettes, the pathognomonic sign of the disease, to no more than 2 collarettes per upper lid) in each study by Day 43, with some patients seeing improvement as early as 2 weeks. Additionally, the endpoints of mite eradication (mite density of 0 mites per lash) and erythema cure (Grade 0) showed statistically significant improvement at Day 43 across both studies.