June 2020
Volume 61, Issue 7
Free
ARVO Annual Meeting Abstract  |   June 2020
Pilot Study to Evaluate the Safety and Efficacy of TP-03 for the Treatment of Blepharitis Due to Demodex Infestation (Mars Study)
Author Affiliations & Notes
  • Hugo Quiroz-Mercado
    Retina, Asociacion para Evitar la Ceguera en Mexico, Mexico City, DISTRITO FEDERAL, Mexico
  • Nallely Ramos-Betancourt
    Cornea Department, Asociación para Evitar la Ceguera en México, Mexico City, Mexico, Mexico
  • Claudia Corredor-Ortega
    Anterior Segment Surgery, Asociación para Evitar la Ceguera en México, Mexico City, Mexico
  • Juan C Ceballos
    Research Department, Asociación para Evitar la Ceguera en México, Mexico City, Mexico, Mexico
  • Martha G Massaro-Corredor
    Research Department, Asociación para Evitar la Ceguera en México, Mexico City, Mexico, Mexico
  • Stephanie N Baba
    Tarsus Pharmaceuticals, California, United States
  • Mark J Holdbrook
    Tarsus Pharmaceuticals, California, United States
  • Roberto Gonzalez-Salinas
    Research Department, Asociación para Evitar la Ceguera en México, Mexico City, Mexico, Mexico
  • Footnotes
    Commercial Relationships   Hugo Quiroz-Mercado, Tarsus Pharmaceuticals (I); Nallely Ramos-Betancourt, Tarsus Pharmaceuticals (C); Claudia Corredor-Ortega, Tarsus Pharmaceuticals (C); Juan C Ceballos, Tarsus Pharmaceuticals (C); Martha G Massaro-Corredor, Tarsus Pharmaceuticals (C); Stephanie N Baba, Tarsus Pharmaceuticals (E); Mark J Holdbrook, Tarsus Pharmaceuticals (E); Roberto Gonzalez-Salinas, Allegro Ophthalmics (C), LayerBio (C), Sanfer (C), Tarsus Pharmaceuticals (C)
  • Footnotes
    Support  Tarsus Pharmaceuticals
Investigative Ophthalmology & Visual Science June 2020, Vol.61, 2984. doi:
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      Hugo Quiroz-Mercado, Nallely Ramos-Betancourt, Claudia Corredor-Ortega, Juan C Ceballos, Martha G Massaro-Corredor, Stephanie N Baba, Mark J Holdbrook, Roberto Gonzalez-Salinas; Pilot Study to Evaluate the Safety and Efficacy of TP-03 for the Treatment of Blepharitis Due to Demodex Infestation (Mars Study). Invest. Ophthalmol. Vis. Sci. 2020;61(7):2984.

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

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Abstract

Purpose : Currently, there are no FDA approved treatments for blepharitis due to Demodex infestation. TP-03 is a topical ophthalmic preparation of an established acaricide, an isoxazoline, used in veterinary medicine. This study evaluated the safety and efficacy of 0.25% TP-03 for the treatment of blepharitis due to Demodex infestation. The clinical hypothesis for the study was treatment with the TP-03 topical ophthalmic preparation will result in a significant decrease in the Demodex density (mites/lash) present at Day 28 compared to the Screening visit with no more than mild ocular irritation.

Methods : This was a single-arm, open-label study. In at least one eye, participants were required to have more than 10 cylindrical dandruff (CD) present on the upper lid; mild to severe lid margin erythema; and an average Demodex density, upper and lower eyelids combined, of 1.5 mites or more per lash. Participants administered one drop of TP-03 in each eye, twice a day, for 28 days and were assessed at Days 2, 7, 14, 28, 60 and 90. Efficacy was determined by the decrease in Demodex density (mites per lash) and a decrease in the signs (CD) of blepharitis. Safety was determined by assessing treatment-related adverse events as well as evaluating any changes in visual acuity, intraocular pressure, and slit-lamp biomicroscopy findings.

Results : Follow-up results were available for 15 participants. At baseline, the average mite density was 2.28 ± 0.16 (mean ± standard error of the mean) mites per lash in the analysis eye decreasing to 0.14 ± 0.05 mites per lash after 28 days of treatment; a decrease which was sustained through Day 90. Regarding cylindrical dandruff (CD), for the upper eyelid of the analysis eye, the grade at baseline was 3.07 ± 0.21 decreasing to 0.79 ± 0.19 at Day 28; an improvement that was sustained through the Day 90 visit. Statistically significant decreases in mite density and CD were seen on Day 14 and all subsequent follow-up visits (p ≤ 0.003). No treatment-related adverse events were reported and there were no clinically significant changes in visual acuity, intraocular pressure, and slit-lamp biomicroscopy findings.

Conclusions : This study demonstrated that use of TP-03 was well-tolerated and effective in reducing Demodex density and cylindrical dandruff through 90 days in participants with blepharitis related to Demodex infestation.

This is a 2020 ARVO Annual Meeting abstract.

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