FDA Approves XDEMVY for Treating Demodex Blepharitis on July 25, 2023

Jul 22, 2024

What is XDEMVY prescribed for? 

 XDEMVY is prescribed to treat a parasitic infection of the eye (Demodex blepharitis) that can  especially affect the eyelids.

What is the name of the drug and what does it do?

XDEMVY, pronounced X-DEM-VEE, (generic name: lotilaner)  is a prescription medication approved for the treatment of Demodex blepharitis, a condition caused by an infestation of Demodex mites on the eyelids. 

XDEMVY helps eliminate these mites and reduce the inflammation they cause.

How does it work?

XDEMVY contains lotilaner, an anti-parasitic agent that specifically targets and inhibits gamma-aminobutyric acid (GABA)-gated chloride channels in mites.

 This inhibition paralyzes and eventually kills the mites, thereby treating the infestation and alleviating symptoms of blepharitis.

What did the research discover?

Clinical trials, known as Saturn-1 and Saturn-2, evaluated the safety and efficacy of XDEMVY in 833 patients with Demodex blepharitis. 

These studies demonstrated that XDEMVY significantly reduced the number of mites and improved symptoms in patients after 6 weeks of treatment. 

Many patients had the mites completely removed, and their eyelid redness and irritation significantly improved.

What are some of the side effects?

The side effects listed are from the product manufacturer. As health scientists, we share this information to keep you informed without causing undue worry. Many side effects diminish over time, and not all patients experience them. If prescribed medication, take it as directed and consult your healthcare professional if you have any concerning side effects.

  • Instillation site stinging and burning(stinging or burning sensation when the drops are applied)
  • Chalazion/hordeolum(small lumps that can form on the eyelid due to blocked oil glands)
  • Punctate keratitis(small, dot-like lesions appear on the cornea, potentially causing discomfort and visual disturbances)

What are the dosage recommendations and how is it prescribed?

The recommended dosage of XDEMVY is to instill one drop in each eye twice daily, approximately 12 hours apart, for 6 weeks. 

If using more than one topical ophthalmic drug, administer the drugs at least five minutes apart. If a dose is missed, continue with the next scheduled dose.

Source: 

Highlights of Prescribing Information. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/217603s000lbl.pdf. Accessed 16 July 2024

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