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Multicenter, Double-Masked, Randomized, Safety and Efficacy Study of BRIMOCHOL PF and Carbachol PF Topical Ophthalmic Solution With Emmetropic Phakic and Pseudophakic Presbyopia

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Trial Profile

Multicenter, Double-Masked, Randomized, Safety and Efficacy Study of BRIMOCHOL PF and Carbachol PF Topical Ophthalmic Solution With Emmetropic Phakic and Pseudophakic Presbyopia

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 10 Jun 2025

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At a glance

  • Drugs VTI-001 (Primary) ; Brimonidine; Carbachol
  • Indications Presbyopia
  • Focus Registrational; Therapeutic Use
  • Acronyms BRIO-I
  • Sponsors Visus Therapeutics

Most Recent Events

  • 03 Jun 2025 According to a Tenpoint Therapeutics media release, the USFDA has accepted the NDA for BRIMOCHOL PF for the treatment of presbyopia. PDUFA date has been set for January 28, 2026.
  • 08 Apr 2025 According to a Visus Therapeutics media release, based on BRIO-I and BRIO-II studies, the Company has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for BRIMOCHOL PF for the treatment of presbyopia. The FDA will conduct a standard 60-day filing review to assess the completeness and acceptability of the application for formal review.
  • 04 May 2023 Results presented in the Visus media release.

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