Selective for mites
Lotilaner acts on mite GABA-gated chloride channels to target, paralyze and kill Demodex mites.
Prescription Treatment · Demodex Blepharitis
XDEMVY Lotilaner ophthalmic solution 0.25%.
XDEMVY (lotilaner ophthalmic solution) 0.25% is a prescription eye drop. It is indicated for the treatment of Demodex blepharitis.
0.25%Lotilaner (2.5 mg/mL)
2x dailyOne drop in each eye, about 12 hours apart
6 weeksTreatment course
10 mLFill in an 11 mL bottle
How it works
How XDEMVY works
Lotilaner is a gamma-aminobutyric acid (GABA)-gated chloride channel inhibitor selective for mites. Inhibiting these channels paralyzes the mite, leading to its death. Lotilaner is not an inhibitor of mammalian GABA-mediated chloride channels at up to 30 µM in vitro.
Collarette reduction
In Saturn-1 and Saturn-2, 44% and 55% of XDEMVY patients reached 2 or fewer collarettes per upper lid at Day 43, versus 7% and 12% with vehicle (p<0.01).
Mite eradication
Mite eradication at Day 43 was 68% and 50% with XDEMVY, versus 17% and 14% with vehicle (p<0.01).
Erythema cure
Erythema cure at Day 43 was 19% and 30% with XDEMVY, versus 7% and 9% with vehicle (p<0.01).
Comfortable drop
An average of about 90% of patients in both groups rated the drop neutral to very comfortable.
The formulation
A sterile, multiple-dose aqueous eye drop.
- Twice daily for 6 weeks
- No label contraindications
- Store at room temperature
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Lotilaner 0.25%
A lipophilic active ingredient at 2.5 mg/mL, selective for mite GABA-gated chloride channels.
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Potassium sorbate preserved
The aqueous drop is preserved with potassium sorbate.
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Multiple-dose bottle
White, opaque LDPE bottle with an LDPE dropper tip and tan HDPE cap. 10 mL fill in an 11 mL container.
Prescribing
Prescribing and dosing
XDEMVY is prescribed by the eye care provider and used by the patient at home.
Dosing
One drop in each eye twice daily, about 12 hours apart, for 6 weeks. If a dose is missed, continue with the next scheduled dose.
With other drops and contact lenses
Space other topical eye drugs at least 5 minutes apart. Remove contact lenses before instillation and reinsert them 15 minutes after.
Prescribing
ePrescribe to an activated specialty pharmacy, indicating Demodex blepharitis with the appropriate ICD-10 code (B88.01 as of October 1, 2025).
Indication and important safety information
Indication
XDEMVY is indicated for the treatment of Demodex blepharitis.
Important safety information
Contraindications: None
Risk of Contamination: Do not allow the tip of the dispensing container to contact the eye, surrounding structures, fingers, or any other surface in order to minimize contamination of the solution. Serious damage to the eye and subsequent loss of vision may result from using contaminated solutions.
Use with Contact Lenses: Contact lenses should be removed prior to instillation of XDEMVY and may be reinserted 15 minutes following its administration.
Adverse Reactions: The most common ocular adverse reaction observed in controlled clinical studies with XDEMVY was instillation site stinging and burning which was reported in 10% of patients. Other ocular adverse reactions reported in less than 2% of patients were chalazion/hordeolum and punctate keratitis.
Product details
| Dosage form | Sterile ophthalmic solution |
|---|---|
| Strength | Lotilaner 0.25% (2.5 mg/mL) |
| Dosing regimen | One drop in each eye twice daily (approximately 12 hours apart) for 6 weeks |
| Package size | 10 mL fill in an 11 mL container |
| NDC | 81942-125-01 |
| Container | White, opaque LDPE multiple-dose bottle, LDPE dropper tip, tan HDPE cap |
| Storage | Store at 15°C to 25°C (59°F to 77°F). After opening, can be used until the expiration date on the bottle. |
Common questions about XDEMVY
What is XDEMVY indicated for?
XDEMVY is indicated for the treatment of Demodex blepharitis.
How is XDEMVY dosed?
One drop in each eye twice daily, approximately 12 hours apart, for 6 weeks.
What if a patient misses a dose?
Treatment should continue with the next scheduled dose.
Can patients wear contact lenses?
Remove contact lenses before instilling XDEMVY. They may be reinserted 15 minutes after.
How should XDEMVY be stored?
Store at 15°C to 25°C (59°F to 77°F). After opening, the bottle can be used until the expiration date on the bottle.
What is the most common side effect?
Instillation site stinging and burning, reported in 10% of patients in controlled clinical studies.
Treat Demodex blepharitis with XDEMVY
Review the full Prescribing Information before prescribing XDEMVY.
XDEMVY is a trademark of Tarsus Pharmaceuticals, Inc. Review the full Prescribing Information before prescribing. Individual results vary.
