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A Phase 2/3 Randomized, Double-Masked, Controlled Trial to Assess the Safety and Efficacy of Intravitreous Administration of Zimura™ (Anti-C5 Aptamer) in Subjects With Geographic Atrophy Secondary to Dry Age-Related Macular Degeneration

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Trial Profile

A Phase 2/3 Randomized, Double-Masked, Controlled Trial to Assess the Safety and Efficacy of Intravitreous Administration of Zimura™ (Anti-C5 Aptamer) in Subjects With Geographic Atrophy Secondary to Dry Age-Related Macular Degeneration

Status: Completed
Phase of Trial: Phase II/III

Latest Information Update: 22 Aug 2023

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At a glance

  • Drugs Avacincaptad pegol (Primary)
  • Indications Dry age-related macular degeneration; Dry macular degeneration
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms GATHER1
  • Sponsors IVERIC bio

    • Most Recent Events

    • 17 Aug 2023 According to an IVERIC bio media release, based on the GATHER1 and GATHER2 clinical trials, the European Medicines Agency (EMA) has accepted for regulatory review the marketing authorization application (MAA) for avacincaptad pegol (ACP) for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD). The CHMP of the EMA will start its review of the MAA under the centralized licensing procedure for all 27 member state of the European Union (EU).
    • 04 Aug 2023 According to an IVERIC bio media release, the U.S. Food and Drug Administration (FDA) approved IZERVAY (avacincaptad pegol intravitreal solution) for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD), approval is based on results of the rate of GA progression at the 12-month primary endpoint across GATHER1 and GATHER2 Phase 3 clinical trials.
    • 23 Apr 2023 According to an IVERIC bio media release, exploratory analyses of data for avacincaptad pegol (ACP), were presented today at the 2023 annual meeting of the Association for Research in Vision and Ophthalmology (ARVO), in New Orleans.
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