Evidence map›Paper›PMID 39873946›Full record

ArticleOphthalmology and therapy2025

Safety and Efficacy of Lotilaner Ophthalmic Solution (0.25%) in Treating Demodex Blepharitis: Pooled Analysis of Two Pivotal Trials.

Elizabeth Yeu, James D Paauw, Patrick Vollmer, Gregg J Berdy, William E Whitson, John Meyer, Blake Simmons, Jared D Peterson, Laura M Periman, Blair E Boehmer and 6 more

2 registry-linked trialsAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Ophthalmology and therapy, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04475432 phase2 / phase3completednot on this map

Randomized, Controlled, Multicenter, Double-Masked, Parallel, Phase 2b/3 Trial to Evaluate the Safety and Efficacy of TP-03 for the Treatment of Demodex Blepharitis

TypeinterventionalSponsorTarsus Pharmaceuticals, Inc.Ran2020 to 2021Enrolled421ConditionsBlepharitisArmsTP-03, 0.25%, TP-03 Vehicle
NCT04784091 phase3completednot on this map

Randomized, Controlled, Multicenter, Double-Masked, Parallel, Phase 3 Trial to Evaluate the Safety and Efficacy of TP-03 for the Treatment of Demodex Blepharitis

TypeinterventionalSponsorTarsus Pharmaceuticals, Inc.Ran2021 to 2022Enrolled412ConditionsBlepharitisArmsTP-03, TP-03 Vehicle
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Pharmacotherapy ofPharmacy (Basel, Switzerland) · 2025
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

16 authors.

Elizabeth YeuVirginia Eye Consultants, 241 Corporate Boulevard, Suite 210, Norfolk, VA, 23502, USA. eyeulin@gmail.com.
James D PaauwPiedmont Eye Center, Lynchburg, VA, USA.
Patrick VollmerVita Eye Clinic, Shelby, NC, USA.
Gregg J BerdyOphthalmology Associates, St. Louis, MO, USA.
William E WhitsonWhitson Vision, Indianapolis, IN, USA.
John MeyerThe Eye Care Institute, Louisville, KY, USA.
Blake SimmonsVision Institute, Colorado Springs, CO, USA.
Jared D PetersonMountain View Eye Center, Layton, UT, USA.
Laura M PerimanPeriman Eye Institute, Seattle, WA, USA.
Blair E BoehmerPankratz Eye Institute, Columbus, IN, USA.
Marc R BloomensteinSchwartz Laser Eye Center, Scottsdale, AZ, USA.
Walter O WhitleyVirginia Eye Consultants, 241 Corporate Boulevard, Suite 210, Norfolk, VA, 23502, USA.
Cecelia KoettingUniversity of Colorado School of Medicine, Aurora, CO, USA.
Kavita DhamdhereTarsus Pharmaceuticals, Inc, Irvine, CA, USA.
Sesha NeervannanTarsus Pharmaceuticals, Inc, Irvine, CA, USA.
Joseph B CiolinoHarvard Medical School, Boston, MA, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionLotilaner ophthalmic solution (0.25%) is the first United States Food and Drug Administration (US FDA)-approved drug for treating Demodex blepharitis. In pivotal trials, it was found to be well tolerated and demonstrated a significant reduction in collarettes and mite density after a 6-week treatment regimen. This study aimed to report the safety and efficacy profile of lotilaner ophthalmic solution (0.25%) from a pooled analysis of two pivotal trials in patients with Demodex blepharitis.

methodsPooled data were analyzed from two randomized, double-masked, vehicle-controlled clinical trials [phase 2b/3 Saturn-1 (NCT04475432) and phase 3 Saturn-2 (NCT04784091)] in which patients with Demodex blepharitis were randomly assigned in a 1:1 ratio to receive either lotilaner ophthalmic solution (0.25%) (study group) or the vehicle formulation without lotilaner (control group), twice daily for 6 weeks. The outcome measures were the proportion of patients with 0-2 collarettes (grade 0 collarettes), mite eradication, erythema cure, and the proportion of patients with ≤ 10 collarettes (grade 0 or 1 collarettes) at day 43.

resultsOverall, 833 participants were randomized to receive either the study drug (N = 415) or vehicle (N = 418). On day 43, 49.8% of patients in the study group vs. 9.9% in the control group (p < 0.0001) had collarette grade 0 (0-2 collarettes). A reduction to ≤ 10 collarettes (grade 0 or 1 collarettes) was achieved in 85.1% of patients in study group vs. 28.0% in control group (p < 0.0001). The proportion of patients achieving mite eradication (60.2% vs. 16.1%, p < 0.0001) and erythema cure (24.9% vs. 7.9%, p < 0.0001) were also statistically significantly higher in the study group compared to the control group. The rates of adverse events were low in both studies, with no serious drug-related ocular adverse events reported. As many as 92% of patients rated the study drop as neutral to very comfortable.

conclusionsTwice-daily treatment with lotilaner ophthalmic solution (0.25%) for 6 weeks demonstrated statistical significance for all outcome measures compared to the vehicle control, with low rates of adverse events and a high rate of drop comfort.

Indexed as

BlepharitisCollarettesDemodex blepharitisLid margin diseaseLotilaner ophthalmic solution 0.25%

Identifiers

PMID39873946
PMCPMC11825414

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.