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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

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Trial Profile

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

Status: Completed
Phase of Trial: Phase II/III

Latest Information Update: 27 Jan 2025

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At a glance

  • Drugs Lotilaner (Primary)
  • Indications Blepharitis
  • Focus Registrational; Therapeutic Use
  • Acronyms Saturn-1
  • Sponsors Tarsus Pharmaceuticals

Most Recent Events

  • 13 Jan 2025 According to a Tarsus Pharmaceuticals media release, Chinese regulatory agency, National Medical Products Administration, accepted the New Drug Application (NDA) submitted by Tarsus's partner, Grand Pharmaceutical Group Ltd., for TP-03 for DB. A decision is anticipated in 2027.
  • 25 Jul 2023 According to a Tarsus Pharmaceuticals media release, the U.S. Food and Drug Administration (FDA) approved XDEMVY (lotilaner ophthalmic solution) 0.25% for the treatment of Demodex blepharitis.
  • 09 Nov 2022 According to a Tarsus Pharmaceuticals media release, data from this study were presented at key medical meetings.

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