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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: 27 Aug 2025

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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

  • 31 Jul 2025 According to a LENZ Therapeutics media release, company announced that the US Food and Drug Administration (FDA) approved VIZZ (aceclidine ophthalmic solution) 1.44%, the first and only FDA-approved aceclidine-based eye drop for the treatment of presbyopia in adults.
  • 19 Mar 2025 According to a LENZ Therapeutics media release, company will host a commercial day to highlight progress towards the potential approval of LNZ100 for the treatment of presbyopia. The event will take place on Tues, 15 Apr 2025, from 2:00 pm- 4:00 pm EST.
  • 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.

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