Xdemvy Approved for Treatment of Demodex Blepharitis

The Food and Drug Administration (FDA) has approved Xdemvy^™ (lotilaner ophthalmic solution) for the treatment of Demodex blepharitis.

Xdemvy contains lotilaner, 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. The product directly targets Demodex mites, the root cause of Demodex blepharitis.

The approval was based on data from two, 6-week randomized, multicenter, double-masked, vehicle-controlled studies (Saturn-1 [ClinicalTrials.gov Identifier: NCT04475432] and Saturn-2 [ClinicalTrials.gov Identifier: NCT04784091). The studies included a total of 833 patients who were randomly assigned to receive either Xdemvy (n=415) or vehicle (n=418) dosed twice daily in each eye.

The primary endpoint of both studies was the proportion of patients cured based on their collarette score. Cure was defined as the presence of no more than 2 collarettes on the upper eyelid.

In Saturn-1, 44% of patients in the Xdemvy arm and 7% of patients in the vehicle arm achieved the primary endpoint at day 43 (P <.01). Additionally, 68% of patients treated with Xdemvy had mite eradication (mite density of 0 mites/lash) compared with 17% of those who received vehicle (secondary endpoint; P <.01). Erythema cure (secondary endpoint) occurred in 19% of Xdemvy-treated patients and 7% of vehicle-treated patients (P <.01).

In Saturn-2, 55% of patients in the Xdemvy arm achieved the primary endpoint compared with 12% of patients in the vehicle group (P <.01). Mite eradication occurred in 50% and 14% of patients in the Xdemvy and vehicle arms, respectively (P <.01). Erythema cure was reported in 30% of Xdemvy-treated patients and 9% of vehicle-treated patients (P <.01).

The most common adverse reaction reported with Xdemvy was instillation site stinging and burning. Chalazion/hordeolum and punctate keratitis were also noted in less than 2% of patients.

“We are thrilled to announce the FDA approval of Xdemvy for the treatment of Demodex blepharitis and look forward to making this product broadly available to the millions of patients who have not had any FDA approved therapeutics for this disease,” said Bobak Azamian, MD, PhD, Chief Executive Officer and Chairman of Tarsus.

Xdemvy is supplied as an ophthalmic solution containing lotilaner 0.25% (2.5mg/mL) in a 10mL bottle. The product is expected to be available by the end of August 2023.