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How to Prescribe

The first and only FDA-approved treatment for Demodex blepharitis (DB)1

XDEMVY is designed to target, paralyze, and kill Demodex mites effectively and safely.

Lotilaner, the active ingredient in XDEMVY1-3:

Is a lipophilic agent in an aqueous drop* that...

Acts specifically via mite GABA-gated chloride channels to...

Target, paralyze, and kill Demodex mites

  GABA=gamma-aminobutyric acid.
*Preserved with potassium sorbate.

In just 6 weeks,
collarettes reduced,
mites eradicated,
erythema cured…
Now that’s might over mites.1

The safety and efficacy of XDEMVY for the treatment of DB was evaluated in a total of 833 patients (415 of whom received XDEMVY) in two 6-week, randomized, multicenter, double-masked, vehicle-controlled studies (SATURN-1 and SATURN-2).1

Patients were randomized to either XDEMVY or vehicle at a 1:1 ratio, dosed twice daily in each eye. All patients enrolled were diagnosed with DB. The primary endpoint and endpoints of mite eradication and erythema cure were defined at Day 43.1,2,5,6

  • Primary efficacy endpoint was defined as the proportion of patients with a reduction of collarettes to no more than 2 per upper eyelid
  • Mite eradication (secondary endpoint) was defined as a mite density of 0 mites/lash in the analysis eye
  • Erythema cure (secondary endpoint in SATURN-2 only) was defined as an erythema score of 0 in the upper eyelid of the analysis eye
  • In post hoc analyses, additional collarette reduction, defined as ≤10 collarettes on the upper eyelid of the analysis eye, was also observed

Inclusion Criteria2,5

  • All sexes, aged ≥18 years
  • Patients with DB that met these criteria in ≥1 eye:
  1. >10 upper lashes with collarettes (≥Grade 2)
  2. Mild or worse upper lid margin erythema
  3. Average Demodex density of ≥1.5 mites/lash (upper and lower eyelids combined)

Select Exclusion Criteria2,5

  • Used any prescription antibacterial, antiparasitic, or anti-inflammatory steroid treatment or had used topical tea tree oil, hypochlorous acid, or any other lid hygiene products within the past 14 days or were unwilling to forego the use of lid hygiene products during this study
  • Used a topical prostaglandin analog (PGA) to promote eyelash growth within the past 30 days, had initiated PGA treatment for medical reasons within the past 30 days, or planned to change or discontinue PGA treatment during the study treatment phase
  • Used contact lenses (SATURN-1 only), artificial eyelashes, or eyelash extensions within the past 7 days or were unwilling to forego the use of these products during this study
  • Lid structural abnormalities; ocular infection; inflammation other than blepharitis; severe dry eye; hypersensitivity to lotilaner or any of the formulation components
  • Pregnant or lactating
  • Major health concerns such as unstable or uncontrolled cardiac, pulmonary, renal, oncological, neurological, metabolic, or other systemic conditions

SATURN-1/SATURN-2 (N=833; 415 received XDEMVY)1,4

In a combined analysis at Day 43, 50% of patients taking XDEMVY (N=402) achieved a collarette reduction to no more than 2 collarettes per upper eyelid vs 10% of patients taking vehicle (N=404)4

Collarette Grade 3 was defined as ≥1/3 to <2/3 of lashes (~100 lashes) with collarettes per eyelid. Collarette Grade 0 was defined as 0 to 2 lashes with collarettes per eyelid.2

Real results

All images are of actual patients who participated in clinical trials for Tarsus Pharmaceuticals.

In a combined analysis at Day 43, 60% of patients taking XDEMVY (N=402) achieved mite eradication vs 16% of patients taking vehicle (N=403)4

Real results

All images are from clinical trials for Tarsus Pharmaceuticals.

In a combined analysis at Day 43, 25% of patients taking XDEMVY (N=402) achieved erythema cure vs 8% of patients taking vehicle (N=404)4

Real results

All images are of actual patients who participated in clinical trials for Tarsus Pharmaceuticals.

IN A POST HOC ANALYSIS OF 2 CLINICAL TRIALS

In a combined analysis at Day 43, 85% of patients taking XDEMVY (N=402) achieved a collarette reduction to no more than 10 collarettes per upper eyelid vs 28% of patients taking vehicle (N=404)4

Collarette Grade 3 was defined as ≥1/3 to <2/3 of lashes (~100 lashes) with collarettes per eyelid. Collarette Grade 1 was defined as 3 to 10 lashes with collarettes per eyelid. Collarette Grade 0 was defined as 0 to 2 lashes with collarettes per eyelid.2
†Post hoc analyses conducted.6

Real results

All images are of actual patients who participated in clinical trials for Tarsus Pharmaceuticals.

XDEMVY is tough on mites, easy on patients1,4

XDEMVY Drop Comfort

OF PATIENTS IN BOTH TRIALS IN THE XDEMVY AND VEHICLE GROUPS REPORTED THE DROP AS NEUTRAL TO VERY COMFORTABLE (ALL VISITS AVERAGED)4

COMBINED SATURN DATA: XDEMVY SAFETY DATA

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 <2% of patients were chalazion/hordeolum and punctate keratitis.1

XDEMVY extension safety study7

STUDY DESIGN: This extension study was designed to observe the incidence of any safety events that might occur up to 1 year after initiation of 6 weeks of treatment with XDEMVY. Additional outcomes were evaluated. There were no restrictions related to the use of concomitant medications or therapies during the observation period. Patients with Demodex blepharitis who completed the SATURN-1 study and presented for the Day 180 visit (N=239) were included in the analysis.

Patients Who Achieved a Reduction to ≤2 Collarettes at Days 43, 180, and 365

Duration of Response Observed in This Trial at Day 365
~50% of patients may have recurrence after completing XDEMVY treatment‡

No serious long-term concerns were observed at Day 365

  • There were 2 treatment-related ocular adverse events, 1 in each group (blurred vision in the XDEMVY group and instillation site pain in the vehicle group)

Based on an extrapolation of the percentages at Days 43 and 365 among patients who completed treatment in the XDEMVY group, approximately 50% of patients who achieved a reduction to ≤2 collarettes at Day 43 may have recurrence at Day 365.

SEE THE IMPACT OF XDEMVY FOR YOURSELF

An average of 50% of patients taking XDEMVY achieved a significant improvement in their eyelids (reduction of collarettes to no more than 2 collarettes per upper lid) at Day 43 vs 10% taking vehicle across 2 combined clinical trials (SATURN-1 and SATURN-2; XDEMVY: N=402, vehicle: N=404).4 All images are of actual patients who participated in clinical trials for Tarsus Pharmaceuticals.

See Real Patient Stories

Real results

Real results

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Demodex blepharitis

Seeing the root of the problem

Dosing

Discover the simplicity of XDEMVY

References: 1. XDEMVY [prescribing information]. Tarsus Pharmaceuticals, Inc; 2023. 2. Yeu E, Wirta DL, Karpecki P, Baba SN, Holdbrook M; Saturn I Study Group. Lotilaner ophthalmic solution, 0.25%, for the treatment of Demodex blepharitis: results of a prospective, randomized, vehicle-controlled, double-masked, pivotal trial (Saturn-1). Cornea. 2022;42:435-443. 3. Toutain CE, Seewald W, Jung M. The intravenous and oral pharmacokinetics of lotilaner in dogs. Parasit Vectors. 2017;10(1):522. 4. Yeu E, Mun J, Vollmer P, et al. Treatment of Demodex blepharitis with lotilaner ophthalmic solution. 0.25%: combined analysis of two pivotal randomized, vehicle-controlled, multicenter trials. Saturn-1 and Saturn-2 combined data. Presented at: ARVO 2023; April 23-27, 2023; New Orleans, LA. 5. Gaddie IB, Donnenfeld ED, Karpecki P, et al; Saturn-2 Study Group. Lotilaner ophthalmic solution 0.25% for Demodex blepharitis: randomized, vehicle-controlled, multicenter, phase 3 trial (Saturn-2). Ophthalmology. 2023;130(10):1015-1023. 6. Data on file, Tarsus Pharmaceuticals, Inc. 7. Sadri E, Paauw JD, Ciolino JB, et al. Long-term outcomes of 6-week treatment of lotilaner 
ophthalmic solution, 0.25%, for Demodex blepharitis: a noninterventional extension study. Cornea. Published online February 9, 2024. doi: 10.1097/ICO.0000000000003484.

INDICATIONS AND USAGE
XDEMVY (lotilaner ophthalmic solution) 0.25% is indicated for the treatment of Demodex blepharitis.

IMPORTANT SAFETY INFORMATION:

WARNINGS AND PRECAUTIONS

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: XDEMVY contains potassium sorbate, which may discolor soft 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 adverse reaction 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.

To report SUSPECTED ADVERSE REACTIONS, contact Tarsus Pharmaceuticals, Inc. at 1-888-421-4002 or the FDA at 1-800-FDA-1088 (www.fda.gov/medwatch).

Please see full Prescribing Information.

INDICATIONS AND USAGE
XDEMVY (lotilaner ophthalmic solution) 0.25% is indicated for the treatment of Demodex blepharitis.

IMPORTANT SAFETY INFORMATION:

WARNINGS AND PRECAUTIONS

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.