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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: 27 Jan 2026

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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

  • 12 Jan 2026 According to an Ocugen media release, company announced the publication of positive Phase 1 GARDian1 trial results for OCU410ST, its novel modifier gene therapy for Stargardt disease, in the peer-reviewed journal Nature Eye published by the Royal College of Ophthalmologists.
  • 12 Jan 2026 Results published in the Media Release
  • 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.

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