The Demodex Blepharitis Patient Journey With XDEMVY® (lotilaner ophthalmic solution) 0.25%

By Marc R. Bloomenstein, OD, FAAO

As an optometrist, my modus operandi is to help patients be proactive with their eye care. Various eye conditions such as Demodex blepharitis (DB) can or may detract from this. There are many obstacles to managing the ocular surface and, unfortunately, the prevalence of DB is much greater than I ever realized. Without a treatment for the root cause of DB, I was not actively looking for nonsymptomatic signs of the disease. When I actively started looking at the base of the lashes, I realized that about 55% to 60% of my patients, regardless of age or gender, had DB. This sea change has transformed my clinical outlook. Now, I simply ask every patient to look down, giving me a clear view of the base of their lash line. I am hunting for collarettes, the pathognomonic, telltale sign of DB.

Bobby is a perfect example of a patient who had refractive surgery whom I had known for years. In the past, I had not thought to look at his lash line.

Bobby is also a personal friend. As a local fire captain who meets regularly with the press, he often had concerns about his appearance with crustiness and would reach out to me for a quick treatment recommendation. His last call to me he stated, “I can’t go out. I’ve got these bumps on my eyelids, and it’s embarrassing and unsightly.” I managed his symptoms the way I normally would—I put him on warm compresses and prescribed a combination of antibiotics and steroids, both topical and systemic. Over the past several years, however, Bobby’s symptoms worsened until I finally diagnosed him with DB. At that time, I didn’t have anything FDA-approved to offer him, I could only offer him a diagnosis and palliative treatments. I knew Bobby would be my patient zero, and as soon as lotilaner ophthalmic solution 0.25% (XDEMVY®, Tarsus Pharmaceuticals) was FDA-approved, we initiated treatment for DB.

After 6 weeks of treatment, I was thrilled with Bobby’s improvement with XDEMVY, and my treatment approach for DB patients changed immediately (Figure 1). The twice a day, 12 hours apart, 6-week course¹ is manageable for patients. It is now my first-line treatment for appropriate DB patients who present with collarettes. I continue to manage the sequelae of other symptoms with palliative therapies.

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.

For years, we glossed over looking for collarettes at the base of the eyelash. We knew they’re associated with Demodex, but we had no FDA-approved treatment to eradicate the mites and no way to target the source of the disease. In pivotal trials at Day 43, 44% (N = 209) and 55% (N = 193) of patients receiving XDEMVY in SATURN-1 and SATURN-2, respectively, achieved collarette reduction to ≤2 collarettes vs. 7% (N = 204) and 12% (N = 200) taking vehicle (P < 0.01 for both studies).² Patients with DB were randomized to either XDEMVY (lotilaner ophthalmic solution) 0.25% or vehicle at a 1:1 ratio, dosed twice daily in each eye for 6 weeks.² Now that XDEMVY is available, we can help patients like Bobby find relief and get to the root cause of DB. It’s been gratifying to see how patients can improve after the 6-week course of treatment.

1. XDEMVY [prescribing information]. Tarsus Pharmaceuticals, Inc; 2023.

2. 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.

By Vin T. Dang, OD, FAAO

About 40% of my patients have Demodex blepharitis (DB). A few years ago, I might not have thought to examine the eyelids and eyelashes for Demodex in every patient, but now I do. This is especially important when patients mention their eyes feel scratchy and irritated. They may be experiencing signs of DB, but in order to verify, we need to take the time to check.

I use a direct approach to counseling patients with DB. I tell them that they have a parasite or mite infestation on their lashes. I prefer parasite or mite to the term dandruff because I want patients to understand the condition must be taken seriously. I liken the importance of lid hygiene to oral hygiene.

We’ve only recently (July 2023) been able to treat DB adequately with XDEMVY (Tarsus Pharmaceuticals), the first and only FDA-approved treatment for DB. Previously, my treatment management protocol was a stepwise approach starting with generic eyelid wipes and progressing to antibiotic ointment, tea tree oil–based wipes, and finally an in-office deep cleaning procedure.

CASE NO. 2: JERRY

I am a 71-year-old retired educator. I started experiencing a gritty, sandy feeling in my eyes about a decade or more ago. It was affecting my everyday activities. When Dr. Dang told me I had Demodex blepharitis (DB), I had no idea what it was. I was worried that having DB would affect my sight. However, Dr. Dang has a calming presence, and he helped me navigate the diagnosis. At that time, he recommended lid hygiene scrubs and, when appropriate, antibiotic ointments. These would provide some relief, but it was not lasting. Additionally, I was not disciplined enough to keep my eyelids clean regularly unless I noticed buildup.

When XDEMVY was approved, we decided to give it a try and see what happened. I figured it couldn’t be any worse than what I had been accustomed to. I noticed positive changes—I was on the road to being convinced that XDEMVY was a good treatment for me (Figure 1).

My compliance with the twice-daily dosing was manageable; I put the drops in right after I washed my face in the morning. Twelve hours later, I would repeat the routine. I was told the drops could sting upon instillation, but I had zero side effects. In the SATURN-1 and SATURN-2 clinical trials, the most common adverse event—in only 10% of patients—was stinging and burning at the instillation site.¹ Less than 2% of patients experienced chalazion/hordeolum and punctate keratitis.¹ What I would share with other patients with Demodex blepharitis and my being treated with XDEMVY is that I was a little bit apprehensive when it first came, when I was first introduced, because I think I had used three different types of treatments to try to treat my blepharitis. Everything went exactly how I was told it was going to go. Being able to use it, as I've already stated, it's easy. Get up in the morning, 12 hours later, drop it, and you're done with it. You don't have to do a lot with it. So I would tell them to give it a try because it worked for me. I'm extremely pleased with it.

1. XDEMVY [prescribing information]. Tarsus Pharmaceuticals, Inc; 2023.

Now, XDEMVY is my first-line treatment. In the beginning, I brought patients back at the halfway mark to track their progress. Now that I have seen the efficacy of the treatment, I bring them back at 6 weeks. I haven’t had a single patient discontinue the medication.

Overall, the availability of XDEMVY is beneficial to our patients because we can offer an FDA-approved treatment that gets to the root cause of their condition. As much as I like seeing Jerry in the office, I'm glad we were able to treat his DB.