Effective Date

Date of Origin   

10-01-2025           

04-01-2024

Xdemvy® 

(lotilaner)

Ophthalmic solution 

Treatment of Demodex blepharitis

1

Demodex blepharitis

Blepharitis is a chronic inflammation of the eyelid margin and a common cause of chronic ocular inflammation.(2) Demodex, a microscopic ectoparasite, is often implicated in blepharitis. Of more than 1600 species of mites collectively known as Demodex, two (Demodex folliculorum and Demodex brevis) inhabit the human body.(4) Although blepharitis can have various etiologies, including allergic, staphylococcal and seborrheic, one of the most common is Demodex mite infestation and accounts for more than 60% of those with blepharitis affecting approximately 25 million Americans.(3,4) It is characterized by erythema, ocular irritation and discomfort, discharge and debris on the eyelids and lashes and eyelash anomalies. In more advanced stages, there may be corneal involvement.(3) It has long been accepted that the prevalence of Demodex increase with age, affecting more than 80% of those older than 60 years and 100% of those older than 70 years. Demodex blepharitis (DB) is equally present in both sexes and infestation was similar regardless of ethnicity.(3)

The initial evaluation of a patient with symptoms and signs suggestive of blepharitis should include the relevant aspects of the comprehensive medical eye evaluation. The diagnosis of blepharitis is usually based on a typical patient history and characteristic slit lamp biomicroscopic findings.(2) Panelists agreed that slit lamp examination is the most common method used for diagnosing Demodex blepharitis, however visualization of mites is not necessary to make the diagnosis. The diagnosis of DB may be based on the presence of collarettes or mites and is usually based on a typical patient history of signs and symptoms, time of day when symptoms are worse, duration of symptoms, exacerbating conditions (e.g., allergens, smoke, low humidity, contact lenses, diet), medication use, and unilateral or bilateral presentation. Collarettes (cylindrical dandruff) are the most common sign and pathognomonic for DB and can be readily identified at the base of the upper lash margin on downward gaze using a slit lamp.(2,4) Collarettes are waxy in texture and composed of accumulated undigested material, keratinized cells, dead or living mites, eggs and egg casings of mites that form a cylindrical collar that remain at the base of the eyelash follicle. Disease progression starts with increased collarettes leading to inflammation and lid margin erythema, followed by conjunctival injection, lid margin thickening/notching/edema, followed by lash loss/irregularity (misdirection of lashes), and potentially corneal staining.(4) Ocular itching is the symptom most commonly associated with DB, and evidence suggests that patients consider this to be one of the most bothersome symptoms associated with the disease. It is more likely to occur at night or early morning after periods of mite activity, distinguishing it from daytime histamine-related itching. In addition to itching (28%), other common symptoms include redness (21%), watering (15%), dryness, discharge, burning, tearing, foreign body sensation, pain, and blurred (or fluctuating) vision.(2,4)

Treatment of Demodex blepharitis is geared towards mite eradication. The Delphi panel agreed that presence of DB negatively impacts patients’ sense of well-being and, potentially, quality of life and came to consensus that reducing or eradicating mites completely is important. Restoring balance to the ocular ecology is the key to managing Demodex infestation, and mechanical intervention (e.g., lid scrubs, blepharoexfoliation) is an important part of treatment. DEPTH panelists were about evenly split on their preferred strategy for management of DB between tea tree oil and the other half preferring blepharoexfoliation (no FDA labeled treatment options available at the time of the Delphi panel).(4) Improvement in symptoms and signs was recently reported in a small case series in which weekly 50% tea tree oil eyelid scrubs and daily tea- tree- oil shampoo scrubs were used for a minimum of 6 weeks in a group of patients who failed the above treatment methods.(2) Demodex is resistant to a wide range of antiseptic solutions. Weekly lid scrub with 50% tea tree oil and daily lid scrub with tea tree shampoo is effective in eradicating ocular Demodex.(5) The tea tree oil eyelid scrub treatment is effective for eliminating ocular Demodex and improving subjective ocular symptoms.(6)

Efficacy

The safety and efficacy of Xdemvy for the treatment of Demodex blepharitis was evaluated in a total of 833 patients (415 of which received Xdemvy) in two 6-week, randomized, multicenter, double-masked, vehicle-controlled studies (Saturn-1 and Saturn-2). Patients with Demodex blepharitis were randomized to either Xdemvy or Vehicle at a 1:1 ratio dosed twice daily in each eye. Efficacy was demonstrated by improvement in lids (reduction of collarettes to no more than 2 collarettes per upper lid) in each study (Saturn-1 and Saturn-2) by Day 43. The endpoints of mite eradication (mite density of 0 mites/lash) and erythema cure (Grade 0) of Xdemvy vs. Vehicle demonstrated statistically significant improvement at Day 43 across both Saturn-1 (Table 1) and Saturn-2 (Table 2) studies.(1) 

Safety

Xdemvy has no FDA labeled contraindications for use.(1) 

1

Xdemvy prescribing information. Tarsus Pharmaceuticals, Inc. July 2023.  

2

Amescua G, Akpek EK, Farid M, et al. Blepharitis Preferred Practice Pattern®. Ophthalmology. 2019;126(1):P56-P93. doi:10.1016/j.ophtha.2018.10.019

3

Rhee MK, Yeu E, Barnett M, et al. Demodex Blepharitis: A Comprehensive review of the disease, current management, and emerging therapies. Eye & Contact Lens. 2023;49(8):311-318. doi:10.1097/icl.0000000000001003

4

Ayres BD, Donnenfeld E, Farid M, et al. Clinical diagnosis and management of Demodex Blepharitis: The Demodex Expert Panel on Treatment and Eyelid Health (DEPTH). Eye (Lond). 2023;37(15):3249-3255. doi:10.1038/s41433-023-02500-4

5

Gao Y-Y, Di Pascuale MA, Li W, et al. In vitro and in vivo killing of ocular Demodex by tea tree oil. British Journal of Ophthalmology. 2005;89(11):1468-1473. doi:10.1136/bjo.2005.072363

6

Koo H, Kim TH, Kim KW, Wee SW, Chun YS, Kim JC. Ocular Surface Discomfort and Demodex: Effect of Tea Tree Oil Eyelid Scrub in Demodex Blepharitis. Journal of Korean Medical Science. 2012;27(12):1574-1579. doi:10.3346/jkms.2012.27.12.1574

Xdemvy

lotilaner ophth soln

0.25 %

1

Bottle

50

DAYS

Xdemvy

lotilaner ophth soln

0.25 %

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx ; SourceRx-Performance

QL

Quantity Limit for the Target Agent(s) will be approved when ONE of the following is met:

1. The requested quantity (dose) does NOT exceed the program quantity limit OR
2. The requested quantity (dose) exceeds the program quantity limit AND ONE of the following:
   1. BOTH of the following:
      1. The requested agent does NOT have a maximum FDA labeled dose for the requested indication AND
      2. There is support for therapy with a higher dose for the requested indication OR
   2. ​​​​​​The requested quantity (dose) does NOT exceed the maximum FDA labeled dose for the requested indication

Length of Approval: up to 12 months