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A PHASE 1 STUDY TO ASSESS THE SAFETY AND EFFICACY OF OCU410ST FOR STARGARDT DISEASE AND PHASE 2/3 PIVOTAL CONFIRMATORY CLINICAL TRIAL TO ASSESS THE SAFETY AND EFFICACY OF OCU410ST FOR STARGARDT DISEASE

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Trial Profile

A PHASE 1 STUDY TO ASSESS THE SAFETY AND EFFICACY OF OCU410ST FOR STARGARDT DISEASE AND PHASE 2/3 PIVOTAL CONFIRMATORY CLINICAL TRIAL TO ASSESS THE SAFETY AND EFFICACY OF OCU410ST FOR STARGARDT DISEASE

Status: Recruiting
Phase of Trial: Phase II/III

Latest Information Update: 01 Dec 2025

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At a glance

  • Drugs OCU 410 ST (Primary)
  • Indications Cone rod dystrophies; Retinitis pigmentosa; Stargardt disease
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms GARDian; GARDian3
  • Sponsors Ocugen

Most Recent Events

  • 05 Nov 2025 According to an Ocugen media release, 50% enrollment completed to date, we believe recruitment will be completed in the first quarter of 2026. interim data on 50% of patients at eight months of treatment expected mid-year 2026.
  • 13 Aug 2025 According to an Ocugen media release, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) reviewed the study design, endpoints and planned statistical analysis of the ongoing pivotal confirmatory OCU410ST Phase 2/3 GARDian3 clinical trial for Stargardt disease and provided acceptability of a single U.S.-based trial for submission of a Marketing Authorization Application (MAA).
  • 29 Jul 2025 Protocol has been amended with change in Phase, endpoints and patient number.

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