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A Phase 3 trial of OPGx-LCA5 program

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Trial Profile

A Phase 3 trial of OPGx-LCA5 program

Status: Planning
Phase of Trial: Phase III

Latest Information Update: 09 May 2025

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At a glance

  • Drugs OPGx-001 (Primary)
  • Indications Leber congenital amaurosis
  • Focus Registrational; Therapeutic Use

Most Recent Events

  • 05 May 2025 According to Opus Genetics media release, company has been in discussions with the U.S. Food and Drug Administration (FDA) regarding the registration trial design for OPGx-LCA5, with the goal of initiating the study in 2026.
  • 31 Mar 2025 According to Opus Genetics media release, a Type D meeting was held with the FDA in March 2025 to discuss the regulatory path for OPGx-LCA5, including the design of this potential registrational study, including the primary endpoint.
  • 25 Feb 2025 New trial record

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