Xdemvy

Generic name: lotilaner 0.25% ophthalmic solution
Dosage form: eye drops
Drug class: Ophthalmic anti-infectives

Medically reviewed by Carmen Pope, BPharm. Last updated on Jul 26, 2023.

Xdemvy (lotilaner 0.25% ophthalmic) is an anti-parasitic eye drop solution that may be used to treat Demodex blepharitis in adults 18 years of age and older.

Demodex blepharitis is a disease caused by an infestation of the eyelashes and eyelash follicles by Demodex mites, the most common ectoparasite found in humans. It is reasonably common, accounting for 45% of blepharitis cases overall, and 84% in people aged 60 and older. Symptoms of Demodex blepharitis include eyelid margin inflammation, redness, and ocular irritation, and it commonly occurs with rosacea or conditions such as diabetes.

Xdemvy works by inhibiting the gamma-aminobutyric acid (GABA)-gated chloride channels in the Demodex mites to cause paralysis in the mite and its death, and relief of eyelid redness and crusting. Lotilaner does not inhibit GABA-mediated chloride channels in humans at 1100 times the recommended human dose.

Xdemvy was FDA-approved on July 25, 2023.

Warnings

There are no contraindications to the use of Xdemvy.

When instilling the eye drops, do not touch the tip with your fingers or allow the tip of the dispensing container to contact the eye, eyelids, face, or any other surface to minimize contamination of the solution. Serious damage to the eye and subsequent loss of vision may result from using contaminated eyedrop solutions.

Before taking this medicine

Safety and effectiveness in children and young adults under the age of 18 has not been established.

There is no data regarding the use of Xdemvy in pregnant women, but systemic exposure to lotilaner from ocular administration is low and no malformations were reported in animal reproduction studies.

There is no data on the presence of lotilaner in human milk, the effects on the breastfed infant, or milk production; however, systemic exposure to lotilaner from ocular administration is low. Consider the benefits of breastfeeding along with the mother’s need for Xdemvy.

How is Xdemvy administered?

Xdemvy is administered by instilling one drop in each eye twice daily (approximately 12 hours apart) for 6 weeks.

Xdemvy side effects

Common side effects include instillation site stinging and burning, reported in 10% of people using Xdemvy.

Other side effects reported in less than 2% of patients include:

• chalazions (a small bump in the eyelid caused by a blockage of a tiny oil gland – also called a meibomian cyst or eyelid cyst)
• punctate keratitis (fluffy or snowflake white patches on the cornea [also called opacities of the superficial corneal stroma]).

Seek your doctor's advice regarding the continued use of Xdemvy if you:

• experience an eye infection or trauma to the eye
• require eye surgery
• react to the drops, and develop conjunctivitis or eyelid reactions.

Use with Contact Lenses

Xdemvy contains potassium sorbate, which may discolor soft contact lenses. Remove contact lenses before putting Xdemvy into your eye. You may reinsert your lenses 15 minutes after administration.

Use with Other Eye drops or Ointments

Wait 5 minutes after administering Xdemvy before instilling other eye drops or eye ointments in your eye.

What if I miss a dose?

If you miss a dose, just continue treatment with the next dose. Do not double up on doses.

What other drugs will affect Xdemvy?

Xdemvy is not expected to interact with other medications that are given systemically (by mouth) but no studies have been conducted. It is not metabolized by CYP enzymes.

Wait 5 minutes after administering Xdemvy before instilling other eye drops or eye ointments in your eye.

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

Not all possible drug interactions are listed here.

Storage

Store at 15°C to 25°C (59°F to 77°F).

After opening the bottle, Xdemvy can be used until the expiration date on the bottle.

Manufacturer

Tarsus Pharmaceuticals, Inc.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer