Mite-selective action
The drug targets GABA-gated chloride channels in the mite, paralyzing and killing Demodex.
Prescription treatment · Demodex blepharitis
XDEMVY Lotilaner ophthalmic solution 0.25%.
XDEMVY (lotilaner ophthalmic solution) 0.25% is a prescription eye drop indicated for the treatment of Demodex blepharitis. The patient uses it at home after the doctor prescribes it.
0.25%lotilaner, 2.5 mg/mL
Twice a dayone drop per eye, roughly 12 hours apart
6 weekslength of the course
10 mLfilled in an 11 mL bottle
Mechanism
How lotilaner works
Lotilaner inhibits gamma-aminobutyric acid (GABA)-gated chloride channels that are selective for mites. Blocking those channels paralyzes the mite and leads to its death. In vitro, lotilaner does not inhibit mammalian GABA-mediated chloride channels at concentrations up to 30 µM.
Fewer collarettes
At Day 43 in Saturn-1 and Saturn-2, 44% and 55% of patients on XDEMVY had 2 or fewer collarettes on the upper lid, compared with 7% and 12% on vehicle (p<0.01).
Mites eradicated
By Day 43, mite eradication reached 68% and 50% on XDEMVY, compared with 17% and 14% on vehicle (p<0.01).
Erythema cleared
Erythema cure at Day 43 was 19% and 30% on XDEMVY, compared with 7% and 9% on vehicle (p<0.01).
Well tolerated drop
Across both studies, about 90% of patients on average rated the drop neutral to very comfortable.
What is in the bottle
A sterile aqueous eye drop in a multiple-dose bottle.
- Used twice a day for 6 weeks
- No contraindications on the label
- Kept at room temperature
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Lotilaner 0.25%
The active ingredient is lipophilic, dosed at 2.5 mg/mL, and selective for the GABA-gated chloride channels of mites.
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Preserved with potassium sorbate
Potassium sorbate is the preservative in this aqueous solution.
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Multiple-dose bottle
An opaque white LDPE bottle with an LDPE dropper tip and a tan HDPE cap, filled with 10 mL in an 11 mL container.
Prescribing
Writing the prescription and dosing
The eye care provider prescribes XDEMVY and the patient applies it at home.
Dosing
One drop in each eye twice a day, roughly 12 hours apart, for 6 weeks. A missed dose is skipped and the patient resumes with the next scheduled dose.
Other drops and contact lenses
Wait at least 5 minutes between XDEMVY and any other topical eye medicine. Contact lenses come out before the drop and can go back in 15 minutes later.
Sending the prescription
ePrescribe to an activated specialty pharmacy and list Demodex blepharitis with the matching 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 per eye twice daily (about 12 hours apart) for 6 weeks |
| Package size | 10 mL fill in an 11 mL container |
| NDC | 81942-125-01 |
| Container | Opaque white LDPE multiple-dose bottle with LDPE dropper tip and tan HDPE cap |
| Storage | 15°C to 25°C (59°F to 77°F). Once opened, usable until the expiration date printed on the bottle. |
Questions doctors ask about XDEMVY
What is the indication?
XDEMVY is indicated for the treatment of Demodex blepharitis.
What is the dosing schedule?
One drop in each eye twice a day, about 12 hours apart, for 6 weeks.
What happens if a dose is missed?
The patient skips it and picks up with the next scheduled dose.
Can contact lens wearers use it?
Yes, but lenses come out before each drop and can be put back in 15 minutes later.
How do patients store it?
At 15°C to 25°C (59°F to 77°F). An opened bottle is good until the expiration date printed on it.
Which side effect is most common?
Stinging and burning where the drop goes in, reported by 10% of patients in controlled clinical studies.
Prescribe XDEMVY for Demodex blepharitis.
Read the complete Prescribing Information before you prescribe.
XDEMVY is a trademark of Tarsus Pharmaceuticals, Inc. Read the complete Prescribing Information before prescribing. Individual results vary.