June 2021
Volume 62, Issue 8
Open Access
ARVO Annual Meeting Abstract  |   June 2021
Safety and Efficacy of Lotilaner Ophthalmic Solution 0.25% for the Treatment of Demodex Blepharitis: The EUROPA Study
Author Affiliations & Notes
  • Roberto Gonzalez-Salinas
    Department of Research, Asociación para Evitar la Ceguera (APEC), Mexico City, Mexico
  • Elizabeth Yeu
    Virginia Eye Consultants, Norfolk, Virginia, United States
  • Hugo Quiroz-Mercado
    Department of Research, Asociación para Evitar la Ceguera (APEC), Mexico City, Mexico
  • Nallely Ramos-Betancourt
    Department of Research, Asociación para Evitar la Ceguera (APEC), Mexico City, Mexico
  • Claudia Corredor-Ortega
    Department of Research, Asociación para Evitar la Ceguera (APEC), Mexico City, Mexico
  • Juan Carlos Ceballos Galvez
    Department of Research, Asociación para Evitar la Ceguera (APEC), Mexico City, Mexico
  • Martha Massaro-Corredor
    Department of Research, Asociación para Evitar la Ceguera (APEC), Mexico City, Mexico
  • Stephanie N. Baba
    Tarsus Pharmaceuticals, Inc., Irvine, California, United States
  • Mark J. Holdbrook
    Tarsus Pharmaceuticals, Inc., Irvine, California, United States
  • Footnotes
    Commercial Relationships   Roberto Gonzalez-Salinas, Kedalion Therapeutics (C), Laboratorios Sanfer (C), LayerBio Inc (C), Tarsus Pharmaceuticals, Inc (F); Elizabeth Yeu, Tarsus Pharmaceuticals, Inc (C); Hugo Quiroz-Mercado, None; Nallely Ramos-Betancourt, None; Claudia Corredor-Ortega, None; Juan Carlos Ceballos Galvez, None; Martha Massaro-Corredor, None; Stephanie Baba, Tarsus Pharmaceuticals, Inc (E); Mark Holdbrook, Tarsus Pharmaceuticals, Inc (E)
  • Footnotes
    Support  Tarsus Pharmaceuticals
Investigative Ophthalmology & Visual Science June 2021, Vol.62, 1332. doi:
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      Roberto Gonzalez-Salinas, Elizabeth Yeu, Hugo Quiroz-Mercado, Nallely Ramos-Betancourt, Claudia Corredor-Ortega, Juan Carlos Ceballos Galvez, Martha Massaro-Corredor, Stephanie N. Baba, Mark J. Holdbrook; Safety and Efficacy of Lotilaner Ophthalmic Solution 0.25% for the Treatment of Demodex Blepharitis: The EUROPA Study. Invest. Ophthalmol. Vis. Sci. 2021;62(8):1332.

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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract

Purpose : There are no FDA-approved treatments for blepharitis due to Demodex infestation. We performed a prospective, randomized, vehicle-controlled Phase IIb clinical trial to evaluate the safety and efficacy of topical lotilaner ophthalmic solution 0.25% (TP-03, Tarsus Pharmaceuticals, Inc.) in patients with Demodex blepharitis.

Methods : Fifty-four adult participants were randomized 1:1 to the active (A) or vehicle (V) groups. One eye of each patient was defined as the analysis eye. To be included, participants had to have >10 collarettes (cylindrical dandruff) on the upper lid, at least mild upper lid margin erythema, and ≥1.5 mites per lash on the upper and lower lids combined. Lid hygiene treatment and topical antibacterial, antiparasitic or anti-inflammatory agents were not permitted during or 2 weeks before the study. Participants applied 1 drop of TP-03 in both eyes twice daily for 42 days. Primary outcome measures were the percentage of eyes achieving collarette cure (≤2 lashes with collarettes on the upper eyelid), mite eradication (mite density of 0), and a composite of collarette cure and grade 0 erythema. A one-sided Fisher’s exact test with an α of 0.025 was used to compare the proportions between treatment groups.

Results : Collarette cure (Fig 1) was achieved in 72% of the A group and 11% of the V group at 28 days (p<0.001) and 80% of the A group vs. 16% of the V group at 42 days (p<0.001). Mites were eradicated in 56% of the A group and 11% of the V group at 28 days (p=0.006) and in 73% of the A group and 21% of the /v group at 42 days (p=0.003). A composite collarette/erythema cure was achieved in 67% of the A group and 11% of the V group at 28 days (p<0.001) and in 73% of the A group and 11% of the V group at 42 days (p<0.001). There were no serious adverse events and no discontinuations due to adverse events. There was little to no change in mean CDVA or mean IOP in either group. In a post hoc analysis, 93% of the A group had collarette density of Grade 1 (2-10 total collarettes) or less by Day 42. Reduction in mite density by > 50% was seen in 87% of the A group by Day 14.

Conclusions : Treatment with TP-03 for 42 days is safe and shows promising efficacy for the treatment of blepharitis due to Demodex infestation.

This is a 2021 ARVO Annual Meeting abstract.

 

Fig. 1: Summary of cure (collarette grade of 0) in analysis eye (AE) by treatment
arm and visit (A=active, V=Vehicle).

Fig. 1: Summary of cure (collarette grade of 0) in analysis eye (AE) by treatment
arm and visit (A=active, V=Vehicle).

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