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A Phase 3 Multicenter, Randomized, Double Masked, Sham-Controlled Clinical Trial to Assess the Safety and Efficacy of Intravitreal Administration of Zimura (Complement C5 Inhibitor) in Patients with Geographic Atrophy Secondary to Dry Age-Related Macular Degeneration

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A Phase 3 Multicenter, Randomized, Double Masked, Sham-Controlled Clinical Trial to Assess the Safety and Efficacy of Intravitreal Administration of Zimura (Complement C5 Inhibitor) in Patients with Geographic Atrophy Secondary to Dry Age-Related Macular Degeneration

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 18 Feb 2025

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At a glance

  • Drugs Avacincaptad pegol (Primary)
  • Indications Dry age-related macular degeneration; Dry macular degeneration
  • Focus Registrational; Therapeutic Use
  • Acronyms GATHER2
  • Sponsors IVERIC bio

    • Most Recent Events

    • 13 Feb 2025 According to an Astellas Pharma media release, the approval follows Astellas' resubmission of the supplemental New Drug Application (sNDA) for IZERVAY on December 26, 2024, within days of meeting with the FDA to clarify the Agency's feedback provided in the Complete Response Letter (CRL) issued in November 2024.
    • 13 Feb 2025 According to an Astellas Pharma media release, company announced the U.S. Food and Drug Administration (FDA) approved expanded U.S. Prescribing information for IZERVAY™ (avacincaptad pegol intravitreal solution) for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD) based on positive results from the GATHER2 Phase 3 clinical trial.
    • 05 Feb 2025 According to an Astellas Pharma media release, based on the GATHER1 and GATHER2 clinical trials, announced the submission of a New Drug Application (NDA) to Japan's Ministry of Health, Labour and Welfare (MHLW) for Conditional Approval of avacincaptad pegol intravitreal solution (ACP), a synthetic aptamer that inhibits the complement C5 protein, for the treatment of GA secondary to AMD. If approved, ACP has the potential to become the first and only GA treatment available in Japan.

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