Association for Research in Vision and Ophthalmology

Association for Research in Vision and Ophthalmology

Source:

Gonzalez-Salinas R, et al. Pilot study to evaluate the safety and efficacy of TP-03 for the treatment of blepharitis due to Demodex infestation (Mars study). Presented at: Association for Research in Vision and Ophthalmology annual meeting; June 12, 2020 (virtual meeting)

Disclosures: Gonzalez-Salinas reports he is a consultant for Tarsus Pharmaceuticals, Allegro Ophthalmics, Sanfer and LayerBio.
July 06, 2020
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TP-03 may significantly reduce Demodex density, cylindrical dandruff

Source:

Gonzalez-Salinas R, et al. Pilot study to evaluate the safety and efficacy of TP-03 for the treatment of blepharitis due to Demodex infestation (Mars study). Presented at: Association for Research in Vision and Ophthalmology annual meeting; June 12, 2020 (virtual meeting)

Disclosures: Gonzalez-Salinas reports he is a consultant for Tarsus Pharmaceuticals, Allegro Ophthalmics, Sanfer and LayerBio.
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TP-03, a topical ophthalmic preparation of an established acaricide, significantly reduced Demodex density and cylindrical dandruff through 90 days of treatment in a phase 2a pilot study.

“TP-03 is a novel topical ophthalmic drug with uniquely designed properties to most effectively and safely target the mite’s nervous system and paralyze and kill mites. It is currently being developed in a multidose preserved formulation,” Roberto Gonzalez-Salinas, MD, PhD, said at the virtual Association for Research in Vision and Ophthalmology meeting.

Demodex study results infographic

Gonzalez-Salinas and colleagues evaluated the safety and efficacy of 0.25% TP-03 (Tarsus Pharmaceuticals) for the treatment of blepharitis due to Demodex infestation in 15 participants in the single-arm, open-label study. Participants used one drop of the therapy in each eye twice a day for 28 days and were assessed on days 2, 7, 14, 28, 60 and 90, he said.

Researchers evaluated efficacy by the decrease in Demodex density, measured by mites per lash, and decrease in signs of blepharitis. Safety was evaluated by observing treatment-related adverse events and changes in visual acuity, IOP and slit lamp biomicroscopy findings.

The average mite density was 2.28 mites per lash at baseline, which decreased to 0.14 mites per lash after 28 days of treatment. The reduction was sustained through 90 days. Participants had a cylindrical dandruff grade of 3.07 at baseline, which decreased to 0.79 at day 28. The decrease was sustained through 90 days as well, Gonzalez-Salinas said.

The reductions in cylindrical dandruff and mite density at day 14 and subsequent visits were statistically significant (P .003).

Treatment-related adverse events were not observed, and no clinically significant changes in IOP, slit lamp biomicroscopy findings and visual changes were reported, he said.