Managed Care Considerations in the Treatment of Demodex Blepharitis

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AJMC®: Could you describe the current standard of care for Demodex blepharitis and how it has evolved?

PERIMAN: The understanding and management of Demodex blepharitis have evolved quite a bit in recent years. Greater awareness has led to improved identification; the presence of collarettes around the lash base is now recognized as pathognomonic. Even in patients with good lid hygiene and few collarettes, suspicion should remain high for Demodex blepharitis if symptoms such as eyelid itching, redness, meibomian gland dysfunction, red eyes, or ocular rosacea are present. Some patients notice their lashes are irregular and fall out easily. The current standard of care is also evolving with the emergence of a promising therapy now available for effective management.

AJMC: What is known about the efficacy and limitations of using traditional therapies for treating Demodex blepharitis?

PERIMAN: Historically, treatments for Demodex blepharitis have included over-the-counter lid scrubs, tea tree oil, prescription steroids, topical therapy with an antibiotic and sometimes also a steroid, and nonprescription hypochlorous acid spray. However, these indirect methods often fall short in efficacy and depend upon patient adherence to the treatment regimen. Also, these treatments only address the signs and symptoms rather than eliminating the root cause, which is Demodex mite load.

AJMC: Could you describe the challenges patients face regarding adherence to these treatments?

PERIMAN: Patients’ adherence to nightly scrubs and warm compresses is often low due to their limited effectiveness in controlling Demodex blepharitis symptoms. Offering a comfortable, well-tolerated, and rapidly effective strategy can significantly improve adherence to treatment recommendations while providing excellent symptom reduction. This approach enhances patient adherence and treatment outcomes.

AJMC: Could you discuss the clinical efficacy and cost effectiveness of in-office procedures like microblepharoexfoliation and intense pulsed light (IPL) therapy?

PERIMAN: In-office treatments for Demodex blepharitis commonly involve microblepharoexfoliation using rotating brushes, mechanical silicone head treatments, or manual kits, which effectively reduce the Demodex mite load at the eyelash bases. Patients typically experience immediate relief postprocedure. Additionally, IPL is used to directly target Demodex mites and improve the appearance of the lid margin over time. However, IPL cannot treat the lashes directly due to the risk of damaging the follicles. Despite its high cost and limited availability, IPL is valuable for local control of Demodex blepharitis¹ and rosacea and for inflammation reduction in the tear film by targeting inflammatory mediators like interleukin (IL)-17 and IL-6.² These treatments are effective and offered to all patients but may not be accessible to some patients due to their out-of-pocket costs.

AJMC: How does FDA approval of an agent factor into decision-making about a treatment?

PERIMAN: The FDA approval process is rigorous, ensuring that approved treatments meet high standards of safety and efficacy. Clinicians can trust FDA-approved therapies like topical lotilaner ophthalmic solution, 0.25%, which was approved in 2023 for Demodex blepharitis and has an excellent safety and efficacy profile.³ Alternatives such as oral or topical ivermectin lack FDA approval and have not been proven to be safe or effective for Demodex blepharitis. Furthermore, ivermectin cream is formulated for the skin, not the eyes, and is irritating to the ocular surface.

AJMC: Could you describe your experience prescribing lotilaner ophthalmic solution, 0.25%, since its FDA approval?

PERIMAN: My clinical practice participated in the phase 3 clinical trial for lotilaner ophthalmic solution, 0.25%, in treating Demodex blepharitis, and we had a rewarding experience, as we witnessed significant patient improvements within just 2 weeks of starting therapy. Over a 6-week period, compared with placebo, we observed highly significant improvements in lid margin redness and thickening, Demodex mite load, and collarette reduction at the lash line. This treatment demonstrated excellent tolerability and safety. Demodex blepharitis has a high prevalence, affecting approximately 60% of patients seen in eye clinics. Since its approval, we have frequently prescribed lotilaner, 0.25%, and treatment with this targeted medication consistently results in clinical success for our patients. The medication’s tolerability, specificity, and efficacy significantly enhance treatment outcomes in our dry eye disease and ocular surface disease clinic. Lotilaner, 0.25%, complements our overall strategy for managing patients with facial rosacea, ocular rosacea, and meibomian gland dysfunction by addressing Demodex at the eyelash base and inside the meibomian glands, areas that are otherwise challenging to reach.

AJMC: In its 2024 Blepharitis Preferred Practice Pattern,⁴ the American Academy of Ophthalmology mentions lotilaner alongside tea tree oil and other traditional treatments. In your clinical experience, is lotilaner equivalent to these treatments in terms of efficacy, safety, and tolerability?

PERIMAN: The preferred practice pattern may not fully capture the nuances of traditional treatments. These methods lack thorough safety and efficacy studies and often provide subpar results. Tea tree oil in commercial eyelid hygiene preparations, for instance, has a low concentration that is helpful in addressing the bacterial load associated with Demodex blepharitis, but these low concentrations are insufficient to effectively eliminate Demodex mites.^5,6 Similarly, topical ivermectin addresses Demodex mites on the face, but it is not suitable for the delicate eye area and often causes discomfort if it enters the eyes. Having a targeted, safe, and rapid-onset treatment like lotilaner, 0.25%, is a significant improvement, offering better clinical outcomes and quicker relief for patients with Demodex blepharitis.

AJMC: What challenges do clinicians encounter when prescribing lotilaner, 0.25%, for patients with Demodex blepharitis, and how do they address these challenges?

PERIMAN: Often, clinicians face prior authorization obstacles from third-party payers, which can be frustrating. In my opinion, it is not reasonable to require prior authorization for a safe and effective medication for a condition when there are no other safe and effective FDA-approved treatment options. When faced with step-therapy restrictions that require patients to try treatments like tea tree oil or oral ivermectin, we emphasize the lack of evidence for their efficacy in this context. Delayed treatment results in significant patient suffering, delay of surgery, continued symptomatology, and loss of productivity. By advocating for appropriate treatment, we can minimize unnecessary obstacles and ensure timely care for patients, reducing their suffering and improving outcomes.

AJMC: How does Demodex blepharitis impact surgery?

PERIMAN: If untreated, Demodex blepharitis present before surgery—whether it is a blepharoplasty, facelift, cataract, or glaucoma procedure—poses significant risks. Demodex mites carry bacteria, including Staphylococcus spp and Streptococcus spp, which can lead to postoperative complications such as delayed wound healing or even endophthalmitis. Treating Demodex blepharitis before surgery is crucial to reduce these risks and ensure better surgical outcomes. With an available targeted and effective treatment option like lotilaner, 0.25%, it is becoming standard practice to address Demodex blepharitis before any surgical intervention.

AJMC: Demodex blepharitis was almost unknown a couple of years ago to most practitioners. How can the awareness of this disease among health care providers be increased?

PERIMAN: Over time and with scientific and medical advances, we often gain targeted tools for addressing specific disease states, whereas previously, treatment options were more generalized. This lack of specificity often led to trial-and-error approaches with limited effectiveness. The advent of targeted innovations sparked renewed interest in tackling previously challenging conditions like Demodex blepharitis, which evaded efficient and effective management until the approval of lotilaner ophthalmic solution, 0.25%. While other approaches may provide some relief, they often address symptoms rather than the root cause. Embracing a root-cause approach to disease states holds promise for improving efficiency in health care delivery, conserving resources, and enhancing patient outcomes. Clinicians across specialties can contribute by recognizing common symptoms such as red rimmed eyelids, itchy eyelids, and irregular lashes, and inquiring about other dry eye symptoms. Demodex blepharitis is more prevalent than commonly perceived, and lotilaner is an effective treatment option for it.

AJMC: What role does patient education play in managing Demodex blepharitis?

PERIMAN: Educating patients about Demodex blepharitis should be approached in a manner that fosters a sense of curiosity and empowerment. Involving patients in the process by showing them evidence of their condition under a microscope can engage their curiosity and help patients feel empowered and more motivated to participate in their treatment.

AJMC: How, if at all, do you foresee treatment or outcomes of Demodex blepharitis changing in the coming years?

PERIMAN: My prediction is that the direct treatment of Demodex blepharitis with lotilaner, 0.25%, will lead to a reduction in polypharmacy across secondary, tertiary, and quaternary prescriptions. Our clinical experience over the course of nearly a year has shown that simplifying patients’ medication regimens results in cost savings and increased system efficiency. This approach directly addresses the root cause, diminishing the need for medications that only alleviate symptoms.

AJMC: Do you have any closing thoughts?

PERIMAN: Before implementing prior authorization or step therapies requirements for lotilaner ophthalmic solution, 0.25%, long-term cost savings and patient satisfaction should be considered. Lotilaner has the potential to avert complications, improve postoperative outcomes, and reduce rates of repeated operations, especially in surgeries like trabeculectomy surgery.

Patients with Demodex blepharitis often have multiple visits to eye doctors and receive several medications before the condition is accurately diagnosed, incurring significant costs to insurers. Ensuring the correct diagnosis and treatment from the start is a good strategy to save money, enhance effectiveness, and improve efficiency. Reimbursing lotilaner ophthalmic solution, 0.25%, for the treatment of Demodex blepharitis is sensible from both medical and financial standpoints. Additionally, this treatment strategy may mitigate the negative impact upon workplace productivity associated with clinical symptoms shared by dry eye disease and Demodex blepharitis.

REFERENCES

1. Fishman HA, Periman LM, Shah AA. Real-time video microscopy of in vitro Demodex death by intense pulsed light. Photobiomodul Photomed Laser Surg. 2020;38(8):472-476. doi:10.1089/photob.2019.4737

2. Liu R, Rong B, Tu P, et al. Analysis of cytokine levels in tears and clinical correlations after intense pulsed light treating meibomian gland dysfunction. Am JOphthalmol. 2017;183:81-90. doi:10.1016/j.ajo.2017.08.021

3. NDA approval of Xdemvy. FDA. July 24, 2023. Accessed May 22, 2023. https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/217603Orig1s000ltr.pdf

4. Lin A, Ahmad S, Amescua G, et al. Blepharitis Preferred Practice Pattern. Ophthalmology. 2024;131(4):P50-P86. doi:10.1016/j.ophtha.2023.12.036

5. Murphy O, O’Dwyer V, Lloyd-McKernan A. The efficacy of tea tree face wash, 1,2-octanediol and microblepharoexfoliation in treating Demodex folliculorum blepharitis. Cont Lens Anterior Eye. 2018;41(1):77-82. doi:10.1016/j.clae.2017.10.012

6. Epstein IJ, Rosenberg E, Stuber R, Choi MB, Donnenfeld ED, Perry HD. Doublemasked and unmasked prospective study of terpinen-4-ol lid scrubs with microblepharoexfoliation for the treatment of Demodex blepharitis. Cornea. 2020;39(4):408-416. doi:10.1097/ico.0000000000002243