Multidisciplinary perspectives in Demodex blepharitis: A new view of treatment from clinical, payer, and patient perspectives

Abstract

Demodex infestation is the cause of more than two-thirds of all cases of blepharitis in the United States. Although symptoms may include crustiness, redness, or itching of the eyelids, diagnosis can be accomplished through a simple examination of the eyelashes. The presence of a waste product of the Demodex mite, known as collarettes, on the base of the eyelashes is a pathognomonic sign of Demodex blepharitis. Demodex infestation that results in blepharitis may cause blockage and ultimately atrophy of the meibomian glands, worsening dry eye disease. Until recently, management of Demodex blepharitis has been limited by a lack of approved therapy options. Lotilaner ophthalmic solution 0.25%, the first approved therapy for treatment of Demodex blepharitis, has not only been shown to eradicate Demodex mites in one-half to two-thirds of patients following short-term treatment but also demonstrated continued benefits through 1 year of follow-up. In addition to managing Demodex blepharitis, treatment with lotilaner ophthalmic solution 0.25% may aid in the management of dry eye disease and other forms of ocular surface disease caused by complications of Demodex infestation. As a result, it is possible that successful management of Demodex blepharitis may reduce chronic use of health care resources dedicated to managing other chronic ocular conditions. As eye care professionals recognize Demodex infestation as a key mediator of ocular surface disease, increasing diagnostic awareness and addressing this underlying cause of Demodex blepharitis may reduce the need for specialist follow-up care, decrease the need for chronic therapy, and improve patient outcomes. Through routine screening for Demodex infestation and Demodex blepharitis, eye care professionals can now address an underlying factor in ocular surface disease to improve use of health care resources in the community.

Plain language summary

Demodex blepharitis is the cause of more than two-thirds of all cases of blepharitis in the United States. Before lotilaner ophthalmic solution 0.25%, no approved treatment was available. With a 6-week course of lotilaner ophthalmic solution 0.25%, Demodex blepharitis can be successfully treated with lasting benefit. Because Demodex mites contribute to other conditions of eye irritation, treatment may reduce use of other medications to manage eye irritation, reducing medical visits and costs.

Implications for managed care pharmacy

Although Demodex blepharitis is the cause of more than two-thirds of all cases of blepharitis in the United States, until recently, a lack of approved therapy options has limited awareness of the importance of Demodex infestation as a mediator of ocular surface disease. Eye care professionals can now apply limited-duration and lasting therapy for Demodex blepharitis with lotilaner ophthalmic solution 0.25% to address an underlying cause of chronic ocular surface disease, reducing health care resource utilization associated with chronic ocular irritation.

Multidisciplinary Perspectives in Demodex Blepharitis: A New View of Treatment From Clinical, Payer, and Patient Perspectives

Blepharitis is a common ocular surface disease with symptoms of ocular irritation, redness, and eyelid margin inflammation that exists in one-third to one-half of patients visiting eye care professionals.¹ Although Demodex mites are a nearly ubiquitous ectoparasite commonly identified in community-dwelling individuals, these parasites have been implicated in cases of blepharitis. In fact, Demodex blepharitis is the cause of more than two-thirds of all cases of blepharitis in the United States. Signs and symptoms are nonspecific and may include crustiness, redness, and itching of the eyelids.¹ In 2023, the US Food and Drug Administration (FDA) approved lotilaner ophthalmic solution 0.25% as the first treatment specifically indicated for management of Demodex blepharitis.²

Lotilaner ophthalmic solution 0.25% has been proven safe and effective in the pivotal SATURN-1 and SATURN-2 trials, with clinical mite eradication rates of 68% in SATURN-1 and 52% in SATURN-2 following 6 weeks of twice-daily instillation of lotilaner ophthalmic solution 0.25%, and significantly higher than in matching placebo groups (ie, 18% in SATURN-1 and 15% in SATURN-2, respectively; P < 0.0001), with most adverse events being of mild severity.^3,4 A long-term follow-up extension trial of SATURN-1 was conducted and identified potential durable efficacy through 1 year after treatment, as well as continued improvement in erythema.⁵

In a multidisciplinary roundtable discussion on Demodex blepharitis convened by AMC Media Group on behalf of Tarsus Pharmaceuticals, a panel of 5 eye care experts and a patient with Demodex blepharitis convened to discuss the importance of recent developments in the field. Leading the discussion was an ophthalmologist and cornea and cataract ophthalmic surgeon. Participants included an ophthalmologist and cornea, laser cataract, and refractive surgeon, as well as a doctor of optometry specializing in dry eye. Also participating were a pharmacist/payer representative, an ophthalmic assistant, and a patient who received treatment with lotilaner for Demodex blepharitis.

Burden

Demodex blepharitis is a common condition, with an estimated 7 million patients in the United States who may benefit from an effective treatment. Of these patients, only 1.5 million have been diagnosed with Demodex blepharitis and received any form of treatment.^1,6,7 In the eye care population, more than half (58%) of 1,032 patients who underwent slit lamp examination across 6 clinics in the United States were diagnosed with Demodex blepharitis.^1,8 These most recent estimates fall on the higher end of previous estimates of Demodex blepharitis, which ranged from 13% to 70% worldwide.⁹

Despite a high prevalence of Demodex blepharitis in the population, certain groups of patients may be more likely to experience irritation. For example, in patients wearing contact lenses, one study found that approximately half (50.6%) had Demodex infestation.¹ In the same study, although patients with Demodex blepharitis were less likely to wear contact lenses than patients without Demodex blepharitis (8.1% vs 10.8%), the difference was not statistically significant (P = 0.154).¹ Although Demodex infestation may be only one of several factors contributing to contact lens intolerance, considering that up to 27% of contact lens wearers develop intolerance to contact lenses, and that 93% of patients with contact lens intolerance have Demodex infestation, addressing issues that may contribute to contact lens intolerance is a high priority for eye care professionals.^10-12

Although common, the contribution of Demodex blepharitis in ocular surface disease was not well understood until recently. In a study of 524 patients with Demodex blepharitis across 20 ophthalmology and optometry practices in the United States, 99.2% of patients experienced symptoms, and approximately two-thirds (65.3%) of patients experienced both symptoms of itching and redness. More than three-fourths (77.4%) of patients reported that symptoms negatively affected daily life.¹³ Another study of 311 adults with Demodex blepharitis identified major psychosocial impacts, including negative effects on well-being. Approximately half of patients (47%) reported being aware of their eyes all day, an equal proportion of patients (47%) reported difficulty driving at night, and nearly 1 in 4 (23%) patients reported constant worry about their eyes. Moreover, 80% of patients reported negative effects of Demodex blepharitis on metrics of psychosocial well-being.⁸

Risk Factors

Known risk factors for Demodex blepharitis include rosacea, diabetes, and advanced age.¹⁴ Other associated factors include immunosuppression, stress, alcohol use, high levels of sun exposure, and smoking.^14,15 Although previously, Demodex blepharitis was associated with older patients and patients with dermatologic conditions, such as rosacea, perceptions have changed, and panel members now attach low levels of importance to specific risk factors given the ubiquity of Demodex blepharitis as described in the Titan study.¹ Panel members consider Demodex blepharitis an incidental part of evaluation or follow-up, independent of age, comorbidities, or socioeconomic status.

Pathophysiology

Demodex mites affect the eye in multiple ways, from creating direct mechanical damage to acting as a bacterial vector, blocking meibomian glands, inducing granulomatous inflammation, and exaggerating immune response. Furthermore, Demodex mites are a vector for bacteria, increasing the risk of infection, destabilizing the ocular microbiome, and triggering immunologic reactions.^14,16 Understanding the pathophysiology of Demodex blepharitis and its potential to complicate and contribute to the pathophysiology of other ocular surface conditions. For instance, substantial overlap between dry eye disease and Demodex blepharitis observed in the Titan study led investigators to postulate that Demodex blepharitis may contribute to or exacerbate dry eye disease.¹

Demodex Blepharitis Diagnosis

Diagnostic processes have changed in recent years in the identification of Demodex blepharitis. Simple examination has greatly simplified diagnosis because Demodex mites leave a telltale sign that is easily visible (Figure 1).¹⁷ Collarettes, which form around the base of the eyelash follicle, are composed of exudative excretions consisting of keratinized cells, Demodex mites, mite eggs, and egg casings. These can be identified during slit lamp examination simply by instructing patients to look down or close the eyelid to enable the eye care professional to search the upper lash margin for collarettes.¹⁴ Alongside the presence of collarettes, symptoms such as ocular itching are frequently associated with Demodex blepharitis, with itching most commonly reported at night or in the early morning when mites are most active.¹⁴ Alongside itching, which is the most bothersome symptom reported by patients with Demodex infestation, other common bothersome symptoms include dry eyes, irritation of the eyes, a foreign body sensation, and a feeling of burning or tearing.^8,14 With incorporation of screening into a regular general eye health examination, multidisciplinary panelists broadly reported higher rates of Demodex mite infestation than were believed to exist prior to screening. In fact, clinicians reported that Demodex infestation was likely missed in patients with marginal keratitis and chronic acne rosacea, resulting in potentially ineffective therapy given an unidentified root cause.

FIGURE 1.

Demodex and Appearance of Collarettes in Demodex Blepharitis

Treatment

Prior to approval of lotilaner ophthalmic solution 0.25%, the first FDA-approved treatment indicated for management of Demodex blepharitis, treatment options were extremely limited. In the prior treatment era, patients might use tea tree oil–based wipes 2 to 3 times daily to reduce mite load. However, given that treatment was indefinite in duration, panel members directly involved in the treatment of Demodex blepharitis reported poor long-term adherence, which may relate to the toxic and irritating effects of tea tree oil at the lid margin. Although tea tree oil was the prior standard therapy, other off-label options were also limited and included both topical and systemic ivermectin, as well as blepharoexfoliation and, in some cases, intense pulsed light therapy. Despite these limitations, published literature indicates that management of patients with Demodex blepharitis using various off-label therapies has shown improvements in disease signs and symptoms, reductions in mite density, and modest levels of mite eradication.¹⁴ These treatments did not address the root cause, the Demodex mite, and suffered from limitations of high potential for adverse events, high cost, and limited efficacy.

Systemic and topical ivermectin have both been used historically in the management of Demodex blepharitis. Mechanistically, ivermectin is a rational choice given the paralytic effects of ivermectin on the mite resulting from blockade of chloride channels gated by glutamate or γ-amino butyric acid.¹⁸ However, in practice, panel members directly involved in the management of patients with Demodex blepharitis stated that treatment with systemic ivermectin is not appropriate given potential systemic adverse events. When used systemically, drug concentrations within the tissue of the lid margins as suboptimal. Topical therapy with ivermectin, which is not indicated for ocular use or for the treatment of Demodex blepharitis, may be limited by potential adverse events (eg, hypersensitivity reactions).¹⁴

In-office procedural approaches to addressing Demodex blepharitis with blepharoexfoliation and intense pulsed light therapy suffer similar drawbacks. For example, according to expert panelists treating patients with Demodex blepharitis, blepharoexfoliation may remove the detritus associated with Demodex infestation, but the frequency of treatment may not be sufficient. For example, blepharoexfoliation procedures were previously performed a week apart, which was not sufficiently frequent to remove Demodex eggs. Panelists also reported a high cost of blepharoexfoliation treatment compared with current treatment.¹⁴

Nonprescription therapies were also previously common adjuncts to management, with similarly disappointing results. Panel members reported using artificial tears, warm compresses, or Johnson’s baby shampoo as part of management, with efficacy limited to temporary symptomatic relief. In contrast to prior treatment options, lotilaner ophthalmic solution 0.25% represents the first and only FDA-approved therapy for treatment for the management of Demodex blepharitis.²

Clinical Data

The approval of lotilaner ophthalmic solution 0.25% for Demodex blepharitis was based on the SATURN-1 and SATURN-2 pivotal studies (Table 1), as described below.^3,4

TABLE 1.

Primary and Key Secondary Outcomes of Lotilaner Ophthalmic Solution 0.25% Pivotal Trials

SATURN-1		SATURN-2
Timepoint	Clinically meaningful collarette cure (% with lotilaner vs % with vehicle)a	Timepoint	Clinically meaningful collarette cure (% with lotilaner vs % with vehicle)b
Day 8	(23.2% vs 10.6%; P = 0.0003)	Day 8	(3.6% vs 3.4%; P = 0.4622)
Day 15	(40.7% vs 16.3%; P < 0.0001)	Day 15	(18.2% vs 3.5%; P < 0.0001)
Day 22	(60.4% vs 18.4%; P < 0.0001)	Day 22	(28.2% vs 6.0%; P < 0.0001)
Day 43c	(81.3% vs 23.0%; P < 0.0001)	Day 43d	(56.0% vs 12.5%; P < 0.0001)
Timepoint	Mite eradication (mite density of 0 mites/lash) (% with lotilaner vs % with vehicle)	Timepoint	Mite eradication (mite density of 0 mites/lash) (% with lotilaner vs % with vehicle)
Day 43e	(67.9% vs 17.6%; P < 0.0001)	Day 43f	(51.8% vs 14.6%; P < 0.0001)
Timepoint	Erythema cure (grade 0) (% with lotilaner vs % with vehicle)	Timepoint	Erythema cure (grade 0) (% with lotilaner vs % with vehicle)
Day 43e	(19.1% vs 6.9%; P = 0.0001)	Day 43f	(31.1% vs 9.0%; P < 0.0001)

Adapted from Yeu et al3 and Gaddie et al.4

^aProportion of patients with clinically meaningful collarette cure (grade 0-1, ≤10 collarettes) in the upper eyelid of the analysis eye in the study and control groups.

^bProportion of patients with collarette cure (grade 0 [0-2 lashes with collarettes]) in the upper eyelid of the analysis eye in the study and control groups.

^cPrimary endpoint.

^dPrimary endpoint.

^eSecondary endpoint.

^fSecondary endpoint.

SATURN-1

In the prospective, randomized, controlled, double-masked, phase 2b/3 SATURN-1 trial (NCT04475432), 421 patients with Demodex blepharitis were randomized in equal proportions to receive lotilaner ophthalmic solution 0.25% ophthalmic solution 0.25% or its vehicle. Drops were administered to both eyes twice daily over a 6-week treatment course. At day 43, patients receiving lotilaner ophthalmic solution 0.25% attained significantly higher rates of outcome measures of collarette reduction to 2 or fewer collarettes (44.0% vs 7.4%; P < 0.0001), and mite eradication (67.9% vs 17.6%; P < 0.0001). Additional outcomes also favored lotilaner ophthalmic solution 0.25%, including erythema cure (19.1% vs 6.9%; P = 0.0001).³ A noninterventional extension study of SATURN-1 at 6 months and 1 year of follow-up following initiation of the 6-week treatment identified a significantly higher proportion of patients with 0 to 2 collarettes (39.8% vs 2.7% at day 180 and 23.5% vs 2.9% at day 365; P < 0.0001). Continued improvement in erythema was observed over time after completion of the 6-week course of treatment.⁵

SATURN-2

In the similarly designed prospective, randomized, double-masked, vehicle-controlled, multicenter, phase 3 SATURN-2 clinical trial (NCT04784091), 412 patients with Demodex blepharitis were randomized in equal proportions to treatment with lotilaner ophthalmic solution 0.25% or matching vehicle twice daily. After 6 weeks of treatment, investigators reported significantly higher rates of patients with 2 or fewer collarettes (56.0% vs 12.5%; P < 0.0001), mite eradication (51.8% vs 14.6%; P < 0.0001), and erythema cure (31.1% vs 9.0%; P < 0.0001) in the lotilaner ophthalmic solution 0.25% group compared with vehicle.⁴

These findings are consistent with outcomes of clinical studies, as lotilaner ophthalmic solution 0.25% was well tolerated in both the SATURN-1 and SATURN-2 trials (Table 2).^3,4 In SATURN-1, most ocular adverse events were mild, with instillation site pain being the most commonly reported adverse event, reported in 11.8% of participants receiving lotilaner vs 7.7% of participants in the control group. In terms of subjective treatment experience, the vast majority of patients (92%) receiving lotilaner ophthalmic solution 0.25% experienced no discomfort with administration.³ Consistent with safety findings in SATURN-1, most ocular adverse events reported in SATURN-2 were of mild severity. Additionally, patients in SATURN-2 receiving lotilaner ophthalmic solution 0.25% reported high rates of treatment adherence, with 98.7% of drops administered as prescribed and 90.7% of patients describing treatment as neutral to very comfortable.⁴

TABLE 2.

Safety Outcomes of Lotilaner Ophthalmic Solution 0.25% Pivotal Trials

SATURN-1

SATURN-2

Rate of 1 or more ocular treatment-emergent AEs with treatment vs control: (19.8% [42/212] vs 21.5% [45/209]) Ocular AEs (ie, incidence >1.0% in either treatment or control group) Instillation site pain (11.8% vs 7.7%) Instillation site pruritis (1.4% vs 3.3%) Reduced visual acuity (2.8% vs 2.9%) Eye pain (1.4% vs 1.4%) Eye discharge (1.4% vs 1.0%) Chalazion (0.5% vs 1.4%) All ocular AEs in the study group were mild

Rate of 1 or more study drug–related ocular treatment-emergent AEs with treatment vs control: (19.2% [39/203] vs 12.4% [26/209]) Ocular study drug–related AEs (ie, incidence ≥1.0% in either treatment or control group) Instillation site pain (7.9% vs 6.7%) Dry eye (1.5% vs 0.5%) Visual acuity reduced (0.5% vs 1.4%) Chalazion (1.0% vs 0.0%) Conjunctival hyperemia (1.0% vs 0.0%) Eyelid pruritus (1.0% vs 0.0%) Photophobia (1.0% vs 0.0%), visual impairment (0.0% vs 1.0%) Instillation site irritation (1.0% vs 0.0%) Vital dye staining of the cornea present (1.0% vs 0.0%) Most ocular AEs were mild

Adapted from Yeu et al³ and Gaddie et al.⁴

AE = adverse event.

In addition to these clinical data, use of lotilaner is informed by clinical and patient experiences described by panelists in this roundtable discussion, which included ophthalmic surgeons, a doctor of optometry, an ophthalmic assistant, a pharmacist payer representative, and a patient. Key perspectives of these multidisciplinary expert panel members concerning the diagnosis and management of Demodex blepharitis are summarized in the associated table (Table 3).

TABLE 3.

Perspectives on Diagnosis and Management of Demodex Blepharitis

Perspectives in diagnosis

“What we did not know until recently was the profound effect that Demodex blepharitis has on patient quality of life, lid margin disease, and ocular surface disease…Whether they are coming for a regular eye exam, for a cataract evaluation, glaucoma, contact lenses, or dry eye, there is a large percentage of that population in any one of those categories that has Demodex blepharitis…it is an equal-opportunity mite.” —Doctor of optometry specializing in dry eye

“We used to think you have to pluck an eyelash and look at it under the microscope to see the mites, but you don’t need to do that.” —Ophthalmologist and cornea and cataract ophthalmic surgeon

“What we did not know until recently was the profound effect that Demodex blepharitis has on patient quality of life, lid margin disease, and ocular surface disease.” —Ophthalmologist and cornea, laser cataract, and refractive surgeon

“We didn’t know how common [Demodex] was because we weren’t looking for it. Now that we look for it, it has been hiding in plain sight” —Doctor of optometry specializing in dry eye

Perspectives in treatment

“Previously, I would put patients on tea tree oil–based wipes and have patients do these 2 or 3 times a day, basically indefinitely, just to keep their mite load at bay, but compliance was very poor.” —Ophthalmologist and cornea and cataract ophthalmic surgeon

“[Earlier adjunctive management treatments included] artificial tears…warm compresses…and Johnson’s baby shampoo, none of which were particularly effective and offer only temporary symptom relief.” —Ophthalmic assistant

“We had a patient in Boston last week who saw 15 different eye care professionals…patients like these are obviously frustrated, but they also come in with other medications they’ve tried and show us all the things that did not work…[but following treatment with lotilaner] the patients are happier with their therapy and they’ve simplified their lives…we’ve also made it less expensive.” —Ophthalmologist and cornea, laser cataract, and refractive surgeon

“[Findings with lotilaner represent] a really dramatic impact of clearing out those lashes with a 6-week treatment twice daily. In SATURN-1…the majority of patients still had a significant treatment effect and benefit after 1 full year.” —Ophthalmologist and cornea and cataract ophthalmic surgeon

“What really impressed me with the efficacy data or the long-term data is that even the redness of the eyelids improved over time. It actually [improved] between the primary endpoint at around 6 weeks and a year later when they did the extension study.” —Doctor of optometry specializing in dry eye

“The only thing recently that compares with that same euphoria of restoring vision is when you take a patient with a chronic disease that has been bothering them for a decade…and you solve it with a very simple drop twice a day. The euphoria and gratitude of these patients who’ve been placed on lotilaner [ophthalmic solution 0.25%] is one of the most remarkable aspects.” —Ophthalmologist and cornea, laser cataract, and refractive surgeon

Resource utilization

“With one therapy for 6 weeks, studies show the effect lasts for a full year…The alternative for many of these patients is 12 prescriptions prescribed of medications that are more expensive over the course of a year….[and] the cost of using an immunomodulator [such as cyclosporine eye drops or lifitegrast eye drops] is dramatically higher than the cost of using lotilaner [ophthalmic solution 0.25%]…I will make the very strong statement that use of lotilaner [ophthalmic solution 0.25%] saves payers money.” —Pharmacist and payer representative

“Overwhelmingly, my patients are extraordinarily happy, number 1, but number 2, I’m simplifying their regimen…They are using less medication…I think at the end of the day, this is going to be a cost savings to the insurance companies and the third-party payers when you make the right diagnosis” —Ophthalmologist and cornea, laser cataract, and refractive surgeon

“Optometry colleagues of mine are sending over a fair amount of [patients who cannot wear contact lenses anymore]…Patients would come in with a dry eye diagnosis or contact lens intolerant, and I was surprised how often we saw Demodex blepharitis…Most of my colleagues are coming up with the diagnosis [without need to consult additional eye care specialists].” —Doctor of optometry specializing in dry eye

“I used to take [artificial tears] 2 or 3 times an hour… Since treatment with [lotilaner], I find I’m not really using the [artificial tears] as often. I have them with me because I’ve been carrying them around in my pocket all the time for years. It has made an amazing difference to my daily life and what I do.” —Patient with Demodex blepharitis treated with lotilaner

Special Populations

For contact lens wearers, Demodex blepharitis may be associated with contact intolerance. Of note, clinical eye care panel members highlighted that lotilaner ophthalmic solution 0.25% can be instilled twice daily and can be used in patients wearing contact lenses.² Panel members with expertise in eye care management explained that contact lens–wearing patients are counseled to place the drops in twice daily, with the first application of lotilaner at least 15 minutes prior to placement of contact lenses for the day. The second application of lotilaner may be performed after removal of contact lenses in the evening.²

Additionally, patients misdiagnosed with dry eye disease frequently benefit from treatment of Demodex blepharitis, and evidence indicates that Demodex blepharitis may have a role in dry eye pathogenesis.¹ According to panel members and published literature, a lack of control of inflammation in patients with a variety of ocular surface diseases is frequently associated with Demodex blepharitis.¹⁵ Moreover, panel members reported that treatment with lotilaner frequently resolves dry eye disease, further supporting a role of Demodex infestation in the pathogenesis and continuation of dry eye disease. Additionally, according to roundtable panelists, another group of patients who benefit from treatment with lotilaner ophthalmic solution 0.25% are those undergoing cataract surgery. For these patients, panel members reported that treatment of Demodex blepharitis improved eye comfort.

Practical Considerations

From a practical perspective, adherence is crucial to the effectiveness of lotilaner ophthalmic solution 0.25%. The effectiveness of treatment after 1 to 2 weeks may lead to lack of adherence, which is a sufficient duration of therapy to address mites but insufficient to address residual eggs that may lead to recurrence. To address this issue, panel members encouraged other eye care professionals to educate patients that lotilaner treatment must continue longer than 2 weeks to address both the mite and the eggs of the Demodex organism.⁸ Panel members reported that, in the infrequent cases in which patients require retreatment, a lack of adherence to a full 6-week course of treatment was frequently the cause. Fortunately, panel members emphasized that retreatment is relatively uncommon.

Perspectives in Coverage

A pharmacist with a background in managed care representing the payer perspective reported that insurers initially were unfamiliar with Demodex blepharitis and, given a high population prevalence, were initially skeptical of the medical necessity of treatment. What was not immediately apparent to insurers upon initial evaluation was the potential for effective treatment of Demodex blepharitis to reduce health care utilization and chronic use of expensive therapies for dry eye (eg, ophthalmic cyclosporine) and other conditions caused or complicated by Demodex infestation. Another managed care consideration extending beyond the price of medication is the cost of specialist visits with ophthalmology professionals. Eye care professionals report a reduction in the need for medical visits for dry eye, further augmenting a positive cost-benefit proposition of lotilaner ophthalmic solution 0.25%. In support of these statements, a case study described reductions in medication use following treatment with lotilaner in an 18-year-old patient with Demodex blepharitis and a history of recurrent styes, including a chalazion removal surgery. After treatment with lotilaner for 6 weeks, the patient experienced bilateral collarette reduction to grade 0 (0-2 lashes with collarettes bilaterally). Although the patient must continue to monitor for signs and symptoms of Demodex blepharitis, the patient was able to discontinue tea tree oil eyelid scrubs and treatment with an antibiotic ointment, demonstrating the potential for a limited course of treatment with lotilaner to reduce use of other therapies.¹⁹

Potential Consequences of Coverage Gaps

Obtaining coverage for Demodex blepharitis therapy is a high priority given potential long-term consequences of forgoing treatment. These include long-term sequelae of the potential for atrophy of meibomian glands that lubricate and protect the eye. A panel member directly involved in the assessment and treatment of patients with Demodex blepharitis reported that patients undergoing meibography who started with more than 40 functional glands may have as few as 6 functional meibomian glands as a result of Demodex infestation. Beyond the serious potential for blockage and atrophy of the meibomian gland is the potential for reduced quality of life. Panel members explained that major psychosocial complications may result from symptoms of chronic red eyes, severe dry eye, and other complications, such as thinning or loss of eyelashes and recurrent eye infections.

Conclusions

With an appreciation of the burden of Demodex blepharitis, multidisciplinary eye care professionals and managed care professionals can work together to address this common cause of eye irritation. With the potential to recognize and treat the underlying cause of more than two-thirds of all cases of blepharitis in the United States, the eye care team can better address a condition that was previously underdiagnosed and poorly managed.¹ With the approval and widespread availability of the first FDA-approved treatment for Demodex blepharitis, lotilaner ophthalmic solution 0.25%,² roundtable panelists recommended updates to diagnosis and treatment best practices across eye care clinicians and in insurance formularies. Panelists, including both clinicians and managed care professionals, believe that lotilaner ophthalmic solution 0.25% is an effective option and preferable to off-label and over-the-counter treatments (eg, topical tea tree oil, systemic and topical ivermectin, and in-office procedures).

Lotilaner is an FDA-approved treatment option supported by robust evidence, as demonstrated in the pivotal SATURN-1 and SATURN-2 clinical trials.^3-5 By addressing the underlying cause of Demodex blepharitis, lotilaner ophthalmic solution 0.25% has the potential to improve the quality of life, reduce the cost of treatment, and reduce the need for follow-up visits in patients with Demodex blepharitis and associated ocular surface diseases.

Funding Statement

This supplement was conceptualized and funded by Tarsus Pharmaceuticals. Tarsus Pharmaceuticals manufacturers Xdemvy (lotilaner ophthalmic solution) 0.25%.