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A Phase 3, Multi-Center, Randomized, Double-Masked, Sham-Controlled Study to Compare the Efficacy and Safety of Intravitreal Pegcetacoplan Therapy With Sham Injections in Patients With Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (AMD)

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Trial Profile

A Phase 3, Multi-Center, Randomized, Double-Masked, Sham-Controlled Study to Compare the Efficacy and Safety of Intravitreal Pegcetacoplan Therapy With Sham Injections in Patients With Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (AMD)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 10 Apr 2024

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At a glance

  • Drugs Pegcetacoplan (Primary)
  • Indications Dry age-related macular degeneration
  • Focus Registrational; Therapeutic Use
  • Acronyms DERBY
  • Sponsors Apellis Pharmaceuticals

    • Most Recent Events

    • 27 Feb 2024 According to an Apellis Pharmaceuticals media release, the company is planning to initiate a re-examination of the marketing authorization application of SYFOVRE with the European Medicines Agency (EMA) and expecting a final opinion to be issued by the CHMP in the second quarter of 2024.
    • 26 Jan 2024 According to an Apellis Pharmaceuticals media release, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a negative opinion on the marketing authorization application (MAA) of intravitreal pegcetacoplan for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD). Apellis plans to seek immediate re-examination of its application.
    • 14 Dec 2023 According to an Apellis Pharmaceuticals media release, the company will continue working closely with the CHMP, the retina community, and patient advocacy groups with the goal of bringing pegcetacoplan to GA patients in Europe.
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