XDEMVY Dosage & Rx Info | Uses, Side Effects

Xdemvy Generic Name & Formulations

Legal Class

General Description

Lotilaner 0.25%; oph soln.

Pharmacological Class

GABA-gated chloride channel inhibitor.

How Supplied

Soln—10mL

Storage

Store at 15°C to 25°C (59°F to 77°F). After opening the Xdemvy bottle, it can be used until the expiration date on the bottle.

Manufacturer

Tarsus Pharmaceuticals

Generic Availability

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.

Xdemvy Indications

Indications

Demodex blepharitis.

Xdemvy Dosage and Administration

Adult

≥18yrs: 1 drop in each eye twice daily (approx. 12hrs apart) for 6 weeks.

Children

<18yrs: not established.

Xdemvy Contraindications

Not Applicable

Xdemvy Boxed Warnings

Not Applicable

Xdemvy Warnings/Precautions

Warnings/Precautions

Contact lenses (remove; may reinsert lenses 15mins after administration). Pregnancy. Nursing mothers.

Xdemvy Pharmacokinetics

Absorption

Maximum concentration was observed 2hrs after a single dose. In healthy subjects, the peak concentration (C_max) and total exposure (AUC_0-12) of lotilaner in whole blood increased after 42 days of repeated ocular administration from 0.596 to 17.8 ng/mL and from 5.75 to 149 hr•ng/mL for C_max and AUC_0-12 respectively.

Distribution

Plasma protein bound: >99.9%. The partitioning of lotilaner to human blood cell is approximately 10% (range 0–20%).

Metabolism

Not metabolized by CYP enzymes.

Elimination

Half-life: 264 hours (11 days).

Xdemvy Interactions

Interactions

Allow at least 5mins between application of other topical oph agents.

Xdemvy Adverse Reactions

Adverse Reactions

Instillation site reactions (eg, stinging, burning).

Xdemvy Clinical Trials

Clinical Trials

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).

Xdemvy

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