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A Multi-Center, Double-Masked Phase 3 Evaluation of the Safety and Efficacy of LNZ101 for the Treatment of Presbyopia

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Trial Profile

A Multi-Center, Double-Masked Phase 3 Evaluation of the Safety and Efficacy of LNZ101 for the Treatment of Presbyopia

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 23 Dec 2024

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At a glance

  • Drugs Aceclidine (Primary) ; Aceclidine/brimonidine (Primary)
  • Indications Presbyopia
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms CLARITY-2
  • Sponsors LENZ Therapeutics

    • Most Recent Events

    • 21 Oct 2024 According to a LENZ Therapeutics media release, the USFDA has accepted the Company's New Drug Application (NDA) for LNZ100 for the treatment of presbyopia, based on the positive results from the pivotal Phase 3 CLARITY studies, and has assigned a Prescription Drug User Fee Act (PDUFA) target action date of August 8, 2025 for LNZ100. The FDA noted that it is not planning to hold an advisory committee meeting to discuss this application.
    • 14 Aug 2024 According to a LENZ Therapeutics media release, company submitted New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for LNZ100 for the treatment of presbyopia.
    • 10 Jun 2024 According to a LENZ Therapeutics media release, Dr. Bacharach, Dr. Bloomenstein and Dr. Hom were principle inveatigators of this trial.

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