Effective Date

Date of Origin  

04-01-2024           

04-01-2024

Xdemvy™

(lotilaner)

Ophthalmic solution 

An ectoparasiticide (anti-parasitic) indicated for the treatment of Demodex blepharitis.

1

Demodex blepharitis

Demodex blepharitis is a common disease of the eyelid, affecting approximately 25 million Americans.(3) Blepharitis is a chronic inflammation of the eyelid margin and a common cause of chronic ocular inflammation.(2) 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. 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. 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 prevalence is lower among younger university-based populations and reported between 2% and 27%. Demodex blepharitis is equally present in both sexes and infestation was similar regardless of ethnicity.(3)

Collarettes are the pathognomonic sign of Demodex blepharitis. They 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. Collarettes can be readily identified at the base of the upper lash margin on downward gaze using a slitlamp. Ocular itching is the symptom most commonly associated with Demodex blepharitis, 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, allergy-related itching. In addition to itching, other symptoms include dryness, discharge, eye redness, burning, tearing, foreign body sensation, pain, and blurred (or fluctuating) vision.(3)

The American Academy of Ophthalmology notes that a cure is usually not possible for blepharitis but many treatments or treatment combinations may be helpful including: warm compresses, eyelid cleansing, topical and/or systemic antibiotics, and topical anti-inflammatory agents. Patients with recalcitrant blepharitis have responded to therapy directed at decreasing or eradicating the Demodex mites. Oral ivermectin has been reported to be of benefit in some cases of recalcitrant Demodex blepharitis.(2) Ivermectin has long been used safely by dermatologists to treat Demodex-related skin conditions and is known to have an acaricidal effect. Ivermectin improves the signs and symptoms of Demodex blepharitis along with reducing the mite density.(3) 

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

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

2

Amescua, G., Akpek, E. K., Farid, M., Garcia-Ferrer, F. J., Lin, A., Rhee, M. K., Varu, D. M., Musch, D. C., Dunn, S. P., & Mah, F. S. (2019). Blepharitis Preferred Practice pattern®. American Academy of Ophthalmology, 126(1), 56–93. https://doi.org/10.1016/j.ophtha.2018.10.019

3

Rhee, M. K., Yeu, E., Barnett, M., Rapuano, C. J., Dhaliwal, D. K., Nichols, K. K., Karpecki, P., Mah, F. S., Chan, A., Mun, J., & Gaddie, I. B. (2023). Demodex Blepharitis: A Comprehensive Review of the Disease, Current Management, and Emerging Therapies, 49(8), 311–318. https://doi.org/10.1097/icl.0000000000001003 

Xdemvy

lotilaner ophth soln

0.25 %

M ; N ; O ; Y

N

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

Xdemvy

lotilaner ophth soln

0.25 %

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

Step Therapy

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

1. The patient has a medication history of use in the past 90 days with ONE prerequisite agent OR
2. The patient has an intolerance or hypersensitivity to ONE prerequisite agent OR
3. The patient has an FDA labeled contraindication to ALL prerequisite agents

Length of Approval: 2 months

NOTE: if Quantity Limit applies, please refer to Quantity Limit criteria.

*Step therapy requirement may not apply if a prior health plan paid for the medication - documentation of a paid claim may be required.

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. BOTH of the following:
   1. The requested quantity (dose) exceeds the program quantity limit AND
   2. The requested quantity (dose) does NOT exceed the maximum FDA labeled dose for the requested indication  

Length of Approval: 2 months