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A phase 3 pivotal trial of 4D-150 in Patients with Wet AMD

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Trial Profile

A phase 3 pivotal trial of 4D-150 in Patients with Wet AMD

Status: Planning
Phase of Trial: Phase III

Latest Information Update: 16 Jan 2025

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At a glance

  • Drugs 4D-150 (Primary) ; Aflibercept
  • Indications Wet age-related macular degeneration
  • Focus Adverse reactions; Registrational
  • Acronyms 4FRONT-2
  • Sponsors 4D Molecular Therapeutics
  • Most Recent Events

    • 16 Jan 2025 New trial record
    • 10 Jan 2025 According to 4DMT media release, FDA is aligned that a single Phase 3 clinical trial, combined with data from the two planned Phase 3 clinical trials in the 4FRONT wet AMD program, would be acceptable as the basis of a BLA submission for 4D-150 in DME.
    • 10 Jan 2025 According to 4DMT media release,Trial designs and CMC plans aligned with U.S. Food & Drug Administration (FDA) under RMAT designation and European Medicines Agency (EMA) under PRIME designation, based on multiple interactions through December 2024After alignment with FDA and EMA on trial designs for the 4D-150 Phase 3 4FRONT program in wet AMD, 4FRONT-1 and 4FRONT-2 trials on track to initiate in Q1 2025 and Q3 2025 respectively.

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