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A 2-year Phase 3, Multicenter, Prospective, Randomized, Double-Masked, Parallel-Group Study of EYP-1901, a Tyrosine Kinase Inhibitor (TKI), Compared to Aflibercept in Subjects With Wet AMD

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Trial Profile

A 2-year Phase 3, Multicenter, Prospective, Randomized, Double-Masked, Parallel-Group Study of EYP-1901, a Tyrosine Kinase Inhibitor (TKI), Compared to Aflibercept in Subjects With Wet AMD

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 15 Feb 2026

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At a glance

  • Drugs Vorolanib (Primary) ; Aflibercept
  • Indications Wet age-related macular degeneration
  • Focus Registrational; Therapeutic Use
  • Acronyms LUGANO
  • Sponsors EyePoint

Most Recent Events

  • 07 Jan 2026 According to an EyePoint Pharmaceuticals media release, the independent Data Safety Monitoring Committee (DSMC) completed its 2nd scheduled review of the Phase 3 program (LUGANO and LUCIA trials) and recommended continuation of the program, with no protocol modifications.
  • 07 Jan 2026 According to an EyePoint Pharmaceuticals media release, topline data from Phase 3 wet AMD program anticipated beginning in mid-2026. The company is actively preparing for an expeditious NDA filing and FDA review.
  • 06 Aug 2025 According to an EyePoint Pharmaceuticals media release, the company received approval of the Phase 3 protocols for the LUGANO and LUCIA trials by the European Medicines Agency (EMA).

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