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The GUARD Trial - Part 1: A Phase 3 Clinical Trial of Repeated Intravitreal Injections of ADX-2191 Versus Standard-of-Care for Prevention of Proliferaivie Vitreoretinopathy

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Trial Profile

The GUARD Trial - Part 1: A Phase 3 Clinical Trial of Repeated Intravitreal Injections of ADX-2191 Versus Standard-of-Care for Prevention of Proliferaivie Vitreoretinopathy

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 22 Jun 2023

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At a glance

  • Drugs Methotrexate (Primary)
  • Indications Proliferative vitreoretinopathy
  • Focus Registrational; Therapeutic Use
  • Acronyms GUARD
  • Sponsors Aldeyra Therapeutics

Most Recent Events

  • 21 Jun 2023 According to an Aldeyra Therapeutics media release, company plans to conduct a Type C meeting with the FDA in the second half of 2023 to discuss the completion of clinical development of ADX-2191 for the prevention of proliferative vitreoretinopathy.
  • 02 Mar 2023 According to an Aldeyra Therapeutics media release, NDA submission is supported by a combination of more than three decades of published literature on the safety and efficacy of methotrexate and safety data from this trial.
  • 02 Mar 2023 According to an Aldeyra Therapeutics media release, the U.S. Food and Drug Administration (FDA) accepted for Priority Review the New Drug Application (NDA) for ADX-2191 for the treatment of primary vitreoretinal lymphoma. The FDA assigned a Prescription Drug User Fee Act (PDUFA) date of June 21, 2023. The FDA noted that no potential filing review issues have been identified. The company plan to launch ADX-2191 in the United States in the second half of this year, pending approval by the FDA.

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