Demodex blepharitis (DB) is dramatically underdiagnosed.1 An estimated 25 million eye care patients in the United States alone are affected by DB.1,2 Signs of DB including eyelid redness, collarettes, irritation, and inflammation are commonly overlooked by patients because they are similar to symptoms from other eye conditions.3 The presence of Demodex, however, is important to identify, particularly now that we have such a targeted and specific treatment to address it. Lotilaner ophthalmic solution, 0.25% (XDEMVY, Tarsus Pharmaceuticals) was created specifically to treat DB. It paralyzes and kills Demodex mites with a 6-week course of treatment. The drops are taken twice daily in each eye, 12 hours apart.4
XDEMVY is indicated for the treatment of Demodex blepharitis There is a 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.
Please see additional Important Safety Information below.
IDENTIFYING PATIENTS
According to a recent multicenter study, 58% of patients presenting for eye examinations had the presence of collarettes.1 In my comprehensive clinic, every patient completes a detailed questionnaire. They answer questions about conditions such as facial flushing, dandruff of the scalp or the eyebrows, and a history of significant acne in teenage and early adulthood years. Their answers provide clues that DB may be present. Patients also undergo a careful examination. I ask them to look down so that I can check for collarettes around the lash base; that is the pathognomonic sign for DB.1,3 I also look for significant inflammation of the lid margin, telangiectasias, redness, thickening, swelling, and cuffing around the eyelash follicle. I also tell them that we have an FDA-approved treatment that kills Demodex mites.
Often, patients want to know why they have DB. I reassure them that they’ve done nothing wrong; these mites just overpopulate in some individuals and create inflammation. I explain it’s important for us to work together to reduce the population load with an integrated treatment plan. Depending on the severity of the local-regional problem, I offer an in-office deep clean of the eyelids and lashes, intense pulsed light (IPL) treatments, and, now that it’s available, XDEMVY.
In my experience, patients have felt that XDEMVY is tolerable and have seen improvements in lid margin erythema and other signs associated with DB. In both the SATURN-1 and SATURN-2 clinical trials, ~90% of patients reported the drop as neutral to very comfortable.5 The most common adverse event—in only 10% of patients—was stinging and burning at the instillation site.4 Additionally, in pivotal trials at Day 43, 19% (N = 212) and 30% (N = 203) of patients receiving XDEMVY in SATURN-1 and SATURN-2, respectively, achieved erythema cure compared to 7% (N = 209) and 9% (N = 209) taking vehicle (P<0.01 for both studies).5
Some clinicians might feel uneasy talking to patients about Demodex mites. It’s important to not shy away from the conversation, though, because patients come to us looking for a solution to their problems. There may have been some reluctance talking about DB because we didn’t have a definitive way to treat it. Yes, there’s lid hygiene to address the collarettes, hypochlorous acid sprays to control the bacterial component of DB, and IPL to kill mites on the face,6 but nothing was FDA-approved to directly eradicate the mites. Now that we have something to offer them that readily addresses the mites in a 6-week course of treatment, the conversation with patients becomes streamlined. XDEMVY is an easy, straight-line option for patients, targeting the root cause of the disease. It is the only FDA-approved treatment for DB.
Starting the journey
When I hear patients have tried so hard for so long to control their symptoms, that drives me to look for treatment options. I get excited to follow a patient’s journey, especially with XDEMVY because it gets to the root cause of the problem. Scott, one of my long-time patients, initially presented to my clinic with significant eyelid margin redness and a 30-year history of symptoms associated with blepharitis (Figure). I knew it was important to find out whether Demodex was present or not. When we confirmed it was, I immediately prescribed XDEMVY and had high hopes that the treatment would improve his irritation and eyelid health. DB can affect patients' daily activities, but we don't always realize it until they come in for treatment.
Figure. Scott's pre-treatment (left) and 6 weeks post-treatment (right) case images.
Taking 10 seconds to ask your patient to look down and look for the presence of collarettes around the lash base is crucial. The presence of collarettes can help us to make a recommendation to treat DB in a targeted, specific, efficient manner with XDEMVY.
SCOTT’S JOURNEY WITH XDEMVY (LOTILANER OPHTHALMIC SOLUTION) 0.25%
I’m in my early 60s, and I have been dealing with Demodex blepharitis for many years. My symptoms came on suddenly in the late 1990s, but no one could tell me what caused them. My eyes became red and swollen toward the edge, and they were constantly bothersome. Eventually, I learned that I had blepharitis, but no one ever used the term Demodex blepharitis. The basics of lid hygiene, including using baby shampoo, warm compresses, and eyedrops, seemed to have an impact, but my eyes still bothered me. I had no idea what to do, and nothing provided lasting relief.
About 3 years ago, my symptoms got worse, and I was referred to Dr. Periman. At my first appointment, she handed me a large rubber Demodex model that she kept in her office to show patients. That was the most vivid description for me. She explained that Demodex blepharitis was inside my eyelash follicles, and it is a chronic condition that can be controlled with lid hygiene, intense pulsed light (IPL), and eyelid cleansers and wipes to reduce the Demodex on the rest of my face.
Learning about Demodex blepharitis gave me additional insight into what I was dealing with—a mite overgrowth that was causing issues for me. One of the hardest parts about having Demodex blepharitis is that you can’t hide it. My eyelids were red, irritated, and inflamed. The constant maintenance was also an issue. I cleaned my eyelids at least twice a day with tea tree oil and used hypochlorous sprays several times a day. I had IPL on a regular schedule, and I used ivermectin cream on my face.
Dr. Periman told me about the FDA approval and availability of lotilaner ophthalmic solution 0.25% (XDEMVY, Tarsus Pharmaceuticals). I was so excited to hear that an FDA-approved treatment was available to treat the root cause of my disease.
I love the fact that it is easy to use and fits easily into my daily routine. I simply instill a drop in each eye in the morning when I first wake up and again at night before bedtime.
Early on, I had the suspicion that something was happening. My lid margin was less inflamed, and I wasn’t rubbing my eyes as often. When you’ve been living with Demodex blepharitis for as long as I have, these improvements are a fabulous thing.
In just 6 weeks, XDEMVY reduced my eyelid redness.
targeted TREATMENT
Treatment for DB should be tailored to the individual patient and account for the severity of their disease and any comorbid conditions. XDEMVY provides a direct solution to treating patients' Demodex blepharitis. I plan on using the medication anytime I see appropriate patients who report symptoms and have telltale signs, including lid thickening, redness of the lid, and collarettes at the lash base. We have treated about 100 DB cases since XDEMVY was approved by the FDA, and we are impressed with the clinical results.
It’s important to set expectations and ensure patients understand there is no single treatment that will fix all possible symptoms. However, I am excited that we have a targeted way to eradicate Demodex mites in the eyelashes and on the eyelids. Before XDEMVY became available, we could reduce the mite load around the eyes but never on the eyelids. Now, we can target the mites in Demodex blepharitis directly with XDEMVY.
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.
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1. Trattler W, Karpecki P, Rapoport Y, et al. The prevalence of Demodex blepharitis in US eye care clinic patients as determined by collarettes: a pathognomonic sign. Clin Ophthalmol. 2022;16:1153-1164.
2. O’Dell L, Dierker DS, Devries DK, et al. Psychosocial impact of demodex blepharitis. Clin Ophthalmol. 2022:16; 2979-2987.
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.
4. XDEMVY [prescribing information]. Tarsus Pharmaceuticals, Inc; 2023.
5. 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. Paper presented at: ARVO 2023; April 23-27, 2023; New Orleans, LA.
6. Fishman HA, Periman LM, Shah AA. Real-time videu microscopy of in vitro Demodex death by intense pulsed light. Photobiomodul Photomed Laser Surg. 2020;38(8):472-476.
