Xdemvy

Xdemvy (lotilaner ophthalmic solution 0.25%) is a prescription eye drop used to treat Demodex blepharitis (DB) in adults. One drop is instilled into each eye twice daily, approximately 12 hours apart, for 6 weeks. It is the only FDA-approved treatment that directly targets and kills the Demodex mites responsible for this condition.

Demodex blepharitis is a common eyelid condition caused by a parasitic mite infestation of the eyelashes. Symptoms include eyelid itching, redness, swelling, collarettes (dandruff-like deposits at the base of the lashes), and misdirected eyelashes. It accounts for 45% of all blepharitis cases and rises to 84% in people aged 60 and older. It commonly occurs alongside rosacea or diabetes.

Xdemvy (lotilaner ophthalmic solution) received FDA approval on July 25, 2023. There is no generic version currently available.

Before using Xdemvy, tell your healthcare provider if you:

• Are allergic to lotilaner, or any inactive ingredients in Xdemvy
• Wear contact lenses
• Have any other eye conditions or infections
• Are pregnant or planning to become pregnant
• Are breastfeeding or planning to breastfeed.

Xdemvy is not approved for use in children and adolescents.

Common side effects

The most common side effect of Xdemvy is stinging and burning in the eye after instilling the eye drops, which occurred in 10% of patients using Xdemvy in clinical trials. Other reported side effects include:

• Chalazions (meibomian cysts) and hordeolas (styes)
• Punctate keratitis (tiny, pinpoint areas of corneal inflammation).

Serious side effects

Serious eye damage and vision loss can result from using contaminated eye drops. Do not allow the tip of the container to contact the eye, eyelids, face, fingers, or any other surface.

Seek immediate medical advice if you experience any eye injury, infection, eye surgery, or reactions such as conjunctivitis or eyelid reactions while using Xdemvy.

Report side effects to the FDA at 1-800-FDA-1088 or contact Tarsus Pharmaceuticals at 1-888-421-4002.

Xdemvy contains lotilaner, an ectoparasiticide (anti-parasitic agent) that works by blocking nervous system channels in Demodex mites, causing paralysis and death. It selectively targets mite cells without affecting human cells, meaning it treats the underlying cause of Demodex blepharitis rather than just relieving symptoms. Xdemvy has no steroid activity and is unrelated to corticosteroid eye drops used for inflammation.

Xdemvy belongs to the drug class called ectoparasiticides.

Xdemvy significantly outperformed placebo in eliminating Demodex mites and reducing eyelid redness after 6 weeks in 833 patients in two randomised controlled clinical trials, Saturn-1 (NCT04475432) and Saturn-2 (NCT04784091).

Saturn-1 results:

• Complete collarette cure: 44.0% vs 7.4%
• Clinically meaningful collarette reduction: 81.3% vs 23.0%
• Mite eradication: 67.9% vs 17.6%
• Erythema cure: 19.1% vs 6.9%

Saturn-2 results:

• Complete collarette cure: 56.0% vs 12.5%
• Clinically meaningful collarette reduction: 89.1% vs 33.0%
• Mite eradication: 51.8% vs 14.6%
• Erythema cure: 31.1% vs 9.0%

All results P < 0.0001 vs vehicle; over 90% of patients rated the drops as neutral to very comfortable.

Place one drop of Xdemvy into each eye twice daily (approximately 12 hours apart), for 6 weeks.

• Do not allow the dropper tip to contact the eye, eyelids, face, fingers, or any other surface. Contamination can cause serious eye injury.
• If you use other eye drops or ointments, wait at least 5 minutes after administering Xdemvy before instilling them
• Remove contact lenses before using Xdemvy. You may reinsert them 15 minutes after administration. Xdemvy contains potassium sorbate, which can discolor soft contact lenses.

If you miss a dose, skip it and continue with the next scheduled dose. Do not double up.

No formal drug interaction studies have been conducted with Xdemvy. It is not expected to interact with orally administered medicines and is not metabolised by CYP enzymes.

If using other topical eye medications, allow at least 5 minutes between applications.

Tell your healthcare provider about all medicines you take, including prescription and over-the-counter products, vitamins, and herbal supplements.

See the Xdemvy Prescribing Information for updates about interactions.

Store Xdemvy at room temperature between 59°F and 77°F (15°C to 25°C). Once opened, you can continue using the bottle until the expiration date printed on the label.

Active ingredient: lotilaner 0.25%

Preservative: potassium sorbate

Inactive ingredients: edetate disodium, hydroxypropyl methylcellulose (HPMC), polyoxyl 35 castor oil, glycerin, dibasic sodium phosphate, monobasic sodium phosphate, and water for injection.

Supplied as a sterile ophthalmic solution in a 10 mL multiple-dose bottle.

Xdemvy (lotilaner ophthalmic solution) is manufactured for Tarsus Pharmaceuticals, Inc., Irvine, CA 92618.