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Phase 2/3 study of APX3330 in Diabetic Retinopathy

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Trial Profile

Phase 2/3 study of APX3330 in Diabetic Retinopathy

Status: Planning
Phase of Trial: Phase II/III

Latest Information Update: 07 Apr 2025

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At a glance

  • Drugs APX 3330 (Primary)
  • Indications Diabetic retinopathy
  • Focus Registrational; Therapeutic Use
  • Acronyms ZETA-2

Most Recent Events

  • 31 Mar 2025 According to an Opus Genetics media release, the company is seeking a strategic partner to advance late-stage development of APX3330.
  • 19 Dec 2024 According to an Opus Genetics media release, the company has reached agreement with the USFDA on a Special Protocol Assessment (SPA) for a Phase 3 clinical trial evaluating oral APX3330 for the treatment of moderate to severe non-proliferative diabetic retinopathy, the SPA agreement reflects that the proposed Phase 3 trial design, endpoints, and planned analyses will be adequate to support a NDA submission for treatment of NPDR, subject to a successful outcome of the trial and review of all data
  • 06 Jun 2024 According to an Ocuphire Pharma media release, this trial is planned to start in early 2025.

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