Paul Karpecki

Introduction: Demodex blepharitis (DB) is a chronic ocular inflammation caused by Demodex mite infestation of the eyelid. DB is often misdiagnosed, as some of its clinical findings and patient-reported outcomes overlap with those of other ocular surface diseases. The Demodex Expert Panel on Treatment and Eyelid Health (DEPTH) has reached consensus on the symptomatology, diagnosis, and treatment of DB. Consensus findings from the DEPTH group include that collarettes are pathognomonic for DB and that lotilaner ophthalmic solution, 0.25%, the first and only FDA-approved treatment for DB, should be the first-line treatment for the disease. This case series highlights two instances of misdiagnosis that were subsequently re-evaluated using consensus findings from the DEPTH group, leading to a correct diagnosis and effective treatment with XDEMVY^® (lotilaner ophthalmic solution) 0.25%. Case Reports: Two cases of patients with DB are presented. In the first case, a 75-year-old female presented with collarettes, reduced meibomian gland secretions, and lid margin erythema. After an unsuccessful initial treatment for bacterial infection, the patient was diagnosed with DB and prescribed lotilaner ophthalmic solution, 0.25% twice daily for 6 weeks, which improved all clinical findings and patient-reported outcomes. In the second case, a 62-year-old male presented with ocular discomfort, dry eye, and burning and itching sensations. After an unsuccessful initial treatment for dry eye disease, collarettes were detected, and the patient was diagnosed with DB. Subsequent treatment with lotilaner ophthalmic solution, 0.25% reduced collarettes and resolved patient-reported symptoms. Conclusion: These cases highlight patients with DB who were initially misdiagnosed and eventually treated with lotilaner ophthalmic solution, 0.25%. Each case exemplifies the utility of the DEPTH consensus findings in improving the diagnostic path for patients and eye care providers. Future case series from other groups will continue to shed light on the best practices for diagnosing and treating patients with DB.

Demodex blepharitis is a chronic inflammatory ocular condition caused by Demodex mite infestation of the eyelid that can negatively impact quality of life. Currently, lotilaner ophthalmic solution 0.25% is the only FDA-approved treatment for Demodex blepharitis. The Demodex Expert Panel on Treatment and Eyelid Health has established consensus that lotilaner ophthalmic solution 0.25% should be considered the preferred first-line treatment for Demodex blepharitis. We report a patient who presented with collarettes, the pathognomonic sign of Demodex blepharitis, meibomian gland dysfunction, and poor visual acuity. The patient also had a history of neovascular age-related macular degeneration. Consistent with the Demodex Expert Panel on Treatment and Eyelid Health consensus recommendations, the patient was treated with lotilaner ophthalmic solution 0.25%, lid scrubs, and warm compresses. At the 2-month follow-up, collarettes had resolved, and signs of meibomian gland dysfunction had improved. This case supports the Demodex Expert Panel on Treatment and Eyelid Health recommendation that lotilaner ophthalmic solution 0.25% should be considered the preferred first-line treatment for Demodex blepharitis.

Purpose: To reach consensus on Demodex blepharitis (DB) treatment approaches using a modified Delphi process involving 15 ocular surface disease experts. Methods: The Demodex Expert Panel on Treatment and Eyelid Health (DEPTH) consisted of 15 well-published ocular surface disease experts. Panelists completed two online surveys, a live consensus meeting, and a follow-up survey. The surveys consisted of scaled and multiple-choice questions related to the clinical and patient-reported outcomes of DB and its treatment. For the scaled questions using a 1 to 9 Likert scale, consensus was defined as weighted mean scores of 1– 3 and 7– 9, whereas for multiple-choice questions, consensus was achieved when a minimum of 10 of 15 panelists agreed. Results: The DEPTH panel reached consensus that lotilaner ophthalmic solution, 0.25% should be the first-line treatment for DB. Experts agreed no additional clinical findings are needed to prompt treatment with lotilaner ophthalmic solution, 0.25% for patients with > 10 collarettes (12/15), while one additional clinical finding is needed for patients with 0– 2 (11/15) or 3– 10 collarettes (10/15). In the absence of allergies, panelists would consider first-line treatment for DB in a patient with eyelid itching but without collarettes (weighted mean: 7.47; range: 2– 9). Panelists agreed that blepharoexfoliation (weighted mean: 8.27; range: 3– 9) or intense pulsed light (IPL) therapy (weighted mean: 8.4; range: 6– 9) could supplement first-line treatment with lotilaner ophthalmic solution, 0.25%. The DEPTH panelists agreed that topical (10/15) and systemic ivermectin (14/15) are not their preferred treatment for DB. Experts did not reach consensus about the use of tea tree oil to treat DB. Conclusion: Experts achieved consensus on the use of lotilaner ophthalmic solution, 0.25% as the first-line treatment for patients with DB. Panelists also agreed that blepharoexfoliation or IPL therapy could serve supplementally to lotilaner ophthalmic solution, 0.25%, if needed.

The clinical value of upper eyelid meibographic imaging remains relatively underexplored; consequently, it is not commonly used in clinical assessments. However, its significance could be particularly important for the early detection of various ocular diseases and systemic conditions related to the eyes. An analysis of the current literature from the PubMed database, covering the years 2005 to 2023, with additional relevant papers added from cited references was conducted. Failure to diagnose dry eye disease and meibomian gland dysfunction associated with conditions such as Sjögren syndrome or thyroid eye disease in the early stages and taking appropriate action may result in persistent signs and symptoms. This could potentially lead to the development of chronic conditions that directly affect a patient's visual quality, functionality, and overall well-being. Therefore, this review aimed to demonstrate the potential clinical significance of upper eyelid examination as an integral component of comprehensive meibomian gland evaluation.

Demodex blepharitis, a chronic lid margin disease, is caused by an infestation of Demodex mites, the most common ectoparasites in human skin and eyelids. Lotilaner ophthalmic solution, 0.25% (Xdemvy, Tarsus Pharmaceuticals), is the first therapy approved to treat Demodex blepharitis. This narrative review characterizes lotilaner ophthalmic solution, 0.25%, and describes its efficacy, safety, and tolerability. The safety and efficacy of lotilaner ophthalmic solution, 0.25%, for treating Demodex blepharitis was evaluated in four phase 2 and two phase 3 trials. The data of 980 patients included in these phase 2 and 3 clinical trials revealed that the proportion of eyes with a clinically meaningful reduction to 10 or fewer collarettes (the cylindrical, waxy debris found at the base of the eyelashes) ranged from 81 to 93%. The mite eradication rate confirmed by a microscopy of epilated lashes ranged from 52 to 78%. No serious treatment-related adverse events were reported in any of these clinical studies. As high as 92% of the patients receiving lotilaner eyedrops in the phase 3 trials found it to be neutral to very comfortable. Given the positive safety and efficacy outcomes, the drug is likely to become the standard of care in the treatment of Demodex blepharitis.

SIGNIFICANCE: Patients with Demodex blepharitis have a considerable symptomatic burden that negatively impacts their daily activities and well‐being. Despite chronic manifestations of and problems associated with blepharitis that resulted in multiple visits to eye care providers, Demodex blepharitis remained underdiagnosed or misdiagnosed. PURPOSE: This study aimed to evaluate the effect of Demodex blepharitis on patients' daily activities and well‐being. METHODS: This prospective, multicenter, observational study recruited 524 patients with Demodex blepharitis from 20 U.S. ophthalmology and optometry practices. Demodex blepharitis was diagnosed based on the presence of the following clinical manifestations in at least one eye: >10 collarettes on the upper lashes, at least mild lid margin erythema of the upper eyelid, and mite density of ≥1.0 mite/lash (upper and lower combined). Patients were asked to complete a questionnaire related to their symptoms, daily activities, and management approaches. RESULTS: The proportion of patients who experienced blepharitis symptoms for ≥2 years was 67.8%, and for ≥4 years, it was 46.5%. The three most bothersome symptoms ranked were “itchy eyes,” “dry eyes,” and “foreign body sensation.” Overall, 77.4% of patients reported that Demodex blepharitis negatively affected their daily life. One‐third (32.3%) of patients had visited a doctor for blepharitis at least two times, including 19.6% who visited at least four times. Despite having clinical manifestations of Demodex blepharitis confirmed by an eye care provider, 58.7% had never been diagnosed with blepharitis. Commonly used management approaches were artificial tears, warm compresses, and lid wipes. Among those who discontinued their regimen, 45.9% had discontinued because of either tolerability issues or lack of effectiveness. Among contact lens wearers, 64.3% of the patients either were uncomfortable wearing contact lenses or experienced vision changes “sometimes” or “frequently.” CONCLUSION: Demodex blepharitis results in a significant negative impact on daily activities, creating a psychosocial and symptomatic burden on patients.

Newly approved treatments for patients with geographic atrophy are changing the treatment paradigm, highlighting the need for eye care providers (ECPs) to have a set of recommendations on how to best manage GA patients. Here, we outline how to identify various stages of age-related macular degeneration including geographic atrophy (GA) by examining optimal management scenarios implicating various ECPs and reviewing treatment considerations for patients with GA. Early identification of GA will lead to optimal patient outcomes, while a standardized management scenario will reduce clinical burden among ECPs treating patients with GA.

Background: Dry eye disease (DED) is a disorder characterized by loss of tear film homeostasis that causes ocular surface inflammation and damage. The incidence of DED increases with age. Cyclosporine ophthalmic solution 0.09% (CEQUA^®; OTX-101), cyclosporine ophthalmic emulsion 0.05% (Restasis^®; CsA), and lifitegrast ophthalmic solution 5% (Xiidra^®; LFT) are anti-inflammatory agents indicated for DED. This analysis compared treatment patterns in patients with DED receiving OTX-101, CsA, or LFT. Methods: This real-world, retrospective, longitudinal cohort study utilized Symphony Health Integrated Dataverse claims from July 2019 to June 2021. The dataset included all patients with OTX-101 claims and patients with CsA or LFT claims randomly selected 2:1 to OTX-101. Patients were sorted into 3 cohorts based on index treatment. Index date was that of first treatment claim, and follow-up period was from index date to end of clinical activity or data availability. Time to treatment discontinuation (TTD), probability of discontinuation, and treatment persistence were assessed for OTX-101 vs. CsA, then OTX-101 vs. LFT. Subgroup analysis was performed based on age and prior DED treatment. Kaplan-Meier analysis and log-rank test were used to examine TTD. A logistic model evaluated association between index treatment and discontinuation. Unadjusted and adjusted odds ratios, 95% confidence intervals, and P-values were reported, with statistically significant associations based on P-values < 0.05. Results: Overall, 7102 patients (OTX-101 n = 1846; CsA n = 2248; LFT n = 3008) were eligible. Median TTD was 354 days for patients receiving OTX-101 vs. 241 days for CsA and 269 days for LFT. Log-rank test indicated TTD was significantly longer for patients on OTX-101 vs. CsA (P = 0.033). Patients on CsA were 35% more likely to discontinue treatment than patients on OTX-101; OTX-101 and LFT groups had similar discontinuation rates. After 360 days, 49.8% of patients receiving OTX-101 remained on treatment vs. 39.4% of patients on CsA (P = 0.036) and 44.0% of patients on LFT (P = 0.854). Conclusions: Patients receiving OTX-101 remained on treatment significantly longer and were significantly less likely to discontinue treatment than patients on CsA. Older patients remained on OTX-101 significantly longer than CsA. These findings highlight treatment pattern differences in patients with DED receiving these anti-inflammatory agents.

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