Safety and efficacy of lotilaner ophthalmic solution, 0.25% for the treatment of blepharitis due to demodex infestation: A randomized, controlled, double-masked clinical trial

González-Salinas, Roberto; Karpecki, Paul; Yeu, Elizabeth; Holdbrook, Mark; Baba, Stephanie N.; Ceballos, Juan Carlos; Massaro-Corredor, Martha; Corredor-Ortega, Claudia; Ramos-Betancourt, Nallely; Quiroz‐Mercado, Hugo

doi:10.1016/j.clae.2021.101492

Cited by 17 publications

(12 citation statements)

References 43 publications

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“…12,29,30,49,50 Before this phase 2b/3 study, the study drug, topical lotilaner ophthalmic solution, 0.25%, has been extensively evaluated in several phase 2 clinical trials. [33][34][35][36] In the first 2 clinical trials, Mars (single-arm pilot study, n = 15) and Jupiter (vehicle-controlled study, n = 60), patients with Demodex blepharitis were treated with lotilaner ophthalmic solution, 0.25%, for 4 weeks and followed for an additional 2 months after treatment cessation. 34,35 Statistically significant reductions in collarette grade and mite density were reported, and the improvement observed during the treatment period was maintained for at least 2 months after treatment cessation.…”

Section: Discussionmentioning

confidence: 99%

“…[33][34][35][36] In the first 2 clinical trials, Mars (single-arm pilot study, n = 15) and Jupiter (vehicle-controlled study, n = 60), patients with Demodex blepharitis were treated with lotilaner ophthalmic solution, 0.25%, for 4 weeks and followed for an additional 2 months after treatment cessation. 34,35 Statistically significant reductions in collarette grade and mite density were reported, and the improvement observed during the treatment period was maintained for at least 2 months after treatment cessation. In the next 2 clinical trials, Io (n = 18) and Europa (n = 54), a longer treatment duration of 6 weeks was evaluated 33,36 where the additional treatment improved the outcomes.…”

Section: Discussionmentioning

confidence: 99%

“…32 The safety and efficacy of lotilaner ophthalmic solution, 0.25% (TP-03, Tarsus Pharmaceuticals Inc, Irvine CA), has been evaluated previously in humans in 2 single-arm 33,34 and 2 vehicle-controlled phase 2 studies with sample sizes ranging from 15 to 60 patients. 35,36 In these studies, lotilaner ophthalmic solution, 0.25%, was found to be well-tolerated, safe, and effective in reducing collarettes and mite density after 28-day or 42-day treatment regimens, with 42-day treatment yielding greater improvements in collarette grade and Demodex density.…”

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confidence: 96%

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Lotilaner Ophthalmic Solution, 0.25%, for the Treatment of Demodex Blepharitis: Results of a Prospective, Randomized, Vehicle-Controlled, Double-Masked, Pivotal Trial (Saturn-1)

Yeu¹,

Wirta²,

Karpecki³

et al. 2022

Cornea

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Purpose: The purpose of this study was to evaluate the safety and efficacy of lotilaner ophthalmic solution, 0.25%, compared with vehicle for the treatment of Demodex blepharitis. Methods: In this prospective, randomized, controlled, double-masked, phase 2b/3 clinical trial, 421 patients with Demodex blepharitis were randomly assigned in a 1:1 ratio to receive either lotilaner ophthalmic solution, 0.25% (study group), or vehicle without lotilaner (control group) bilaterally, twice daily for 43 days. Patients were evaluated at days 8, 15, 22, and 43. Outcome measures were complete collarette cure (collarette grade 0), clinically meaningful collarette cure (grade 0 or 1), mite eradication (0 mites/lash), erythema cure (grade 0), composite cure (grade 0 for collarettes/erythema), and drop comfort. Adverse events were also evaluated. Results: At day 43, the study group achieved a statistically significantly higher proportion of patients with clinically meaningful collarette cure (81.3% vs. 23.0%; P < 0.0001), complete collarette cure (44.0% vs. 7.4%; P < 0.0001), mite eradication (67.9% vs. 17.6%; P < 0.0001), erythema cure (19.1% vs. 6.9%; P = 0.0001), and composite cure (13.9% vs. 1.0%; P < 0.0001) than the control group. Nearly 92.0% of patients rated the study drop as neutral to very comfortable. All ocular adverse events in the study group were mild, with the most common being instillation site pain. Conclusions: Twice-daily treatment with a novel lotilaner ophthalmic solution, 0.25% for 43 days, is safe and effective for the treatment of Demodex blepharitis compared with the vehicle control.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

mentioning

confidence: 96%

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Lotilaner Ophthalmic Solution, 0.25%, for the Treatment of Demodex Blepharitis: Results of a Prospective, Randomized, Vehicle-Controlled, Double-Masked, Pivotal Trial (Saturn-1)

Yeu¹,

Wirta²,

Karpecki³

et al. 2022

Cornea

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“…In a second study (TRS-004, ''Jupiter''), 11 we evaluated lotilaner in a randomized-controlled trial, comparing the active ingredient with vehicle, with similar results.…”

Section: Introductionmentioning

confidence: 99%

Collarette Elimination and Demodex Mite Eradication with Topical Lotilaner Ophthalmic Solution, 0.25%

González-Salinas

Yeu

Holdbrook³

et al. 2021

Journal of Ocular Pharmacology and Therapeutics

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Purpose: To evaluate the efficacy of topical lotilaner ophthalmic solution, 0.25%, in patients with Demodex blepharitis. Methods: Eighteen adults with Demodex blepharitis, defined as >10 collarettes on the upper lid and/or mite density of ‡1.5 mites per lash (upper and lower), were treated bid for 42 days with the topical lotilaner ophthalmic solution, 0.25%. Contact lens wear, artificial eyelashes, and lid structural abnormalities were among the exclusion criteria. No other antibacterial, antiparasitic, or anti-inflammatory treatment or lid hygiene products were permitted. One eye of each patient was selected for analysis and assessed on day 7, 14, 28, and 42. Collarettes were graded at each visit, and mite density was evaluated by microscopy at each visit except day 7. Outcome measures were collarette elimination (£2 lashes with collarettes) and mite eradication (0 mites). Drop tolerability, adverse events, visual acuity, and slit-lamp biomicroscopy were assessed. Results: Collarette elimination was achieved in 13/18 participants (72.2%) by day 42. Mean collarette grade (upper lid) declined from 3.56 -0.17 to 0.28 -0.11. Mite eradication was achieved in 14/18 participants (77.8%) by day 42. Mean mite density decreased from 2.63 -0.39 to 0.12 -0.08 mites/lash. Participants reported good tolerability. Adverse events were mild and transient and did not result in treatment discontinuation. Conclusion: Six weeks of at-home topical therapy with the lotilaner ophthalmic solution, 0.25%, was effective in eliminating the most common objective signs of Demodex blepharitis, with a collarette elimination rate of 72% and mite eradication in 78% of eyes by day 42. ISRCTN registration #: 24398865

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“…These findings were consistent with prior pilot studies, Mars and Jupiter, in which patients were treated twice daily for 28 days. 49,50 Because the life cycle of a mite is about 3 weeks, it was thought that lengthening the duration of treatment from 4 to 6 weeks, or 2 full mite life cycles, could improve outcomes. 10,51,52 Thus, the Io study was completed, demonstrating that the longer duration of treatment did, indeed, improve outcomes from mite eradication rates of 66.7% in Jupiter and 57.1% in Mars.…”

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Delphi Panel Consensus Regarding Current Clinical Practice Management Options for Demodex blepharitis

Farid¹,

Ayres²,

Donnenfeld³

et al. 2023

OPTH

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To obtain consensus on Demodex blepharitis (DB) treatment using a modified Delphi panel process. Methods: Literature search identified gaps in knowledge surrounding treatment of DB. Twelve ocular surface disease experts comprised the Demodex Expert Panel on Treatment and Eyelid Health (DEPTH). They completed a live roundtable discussion in addition to 3 surveys consisting of scaled, open-ended, true/false, and multiple-choice questions pertaining to the treatment of DB. Consensus for scaled questions using a 1 to 9 Likert scale was predefined as median scores of 7-9 and 1-3. For other question types, consensus was achieved when 8 of 12 panelists agreed. Results:The experts agreed that an effective therapeutic agent for treatment of DB would likely decrease the necessity of mechanical intervention, such as lid scrubs or blepharoexfoliation (Median = 8.5; Range 2-9). When treating DB, panelists believed that collarettes serve as a surrogate for mites, and that eliminating or reducing collarettes should be the main clinical goal of treatment (Median = 8; Range 7-9). The panelists would treat patients with at least 10 collarettes, regardless of other signs or symptoms and agreed that DB can be cured, but there is always the possibility for a reinfestation (n = 12). There was also consensus that collarettes, and therefore mites, are the primary treatment target and the way by which clinicians can monitor patient response to therapy (Median = 8; Range 7-9). Conclusion: Expert panelists achieved consensus on key facets of DB treatment. Specifically, there was consensus that collarettes are pathognomonic for DB, that DB patients with >10 collarettes should be treated even in the absence of symptoms, and that treatment efficacy can be tracked by collarette resolution. By increasing awareness about DB, understanding the goals of and monitoring treatment efficacy, patients will receive better care and, ultimately, better clinical outcomes.

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Safety and efficacy of lotilaner ophthalmic solution, 0.25% for the treatment of blepharitis due to demodex infestation: A randomized, controlled, double-masked clinical trial

Cited by 17 publications

References 43 publications

Lotilaner Ophthalmic Solution, 0.25%, for the Treatment of Demodex Blepharitis: Results of a Prospective, Randomized, Vehicle-Controlled, Double-Masked, Pivotal Trial (Saturn-1)

Lotilaner Ophthalmic Solution, 0.25%, for the Treatment of Demodex Blepharitis: Results of a Prospective, Randomized, Vehicle-Controlled, Double-Masked, Pivotal Trial (Saturn-1)

Collarette Elimination and Demodex Mite Eradication with Topical Lotilaner Ophthalmic Solution, 0.25%

Delphi Panel Consensus Regarding Current Clinical Practice Management Options for Demodex blepharitis

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