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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: Active, no longer recruiting
Phase of Trial: Phase II/III

Latest Information Update: 14 Apr 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; GARDian 1; GARDian3
  • Sponsors Ocugen

Most Recent Events

  • 01 Apr 2026 Status changed from recruiting to active, no longer recruiting, according to an Ocugen media release.
  • 01 Apr 2026 According to an Ocugen media release, dosing has been successfully completed ahead of schedule. Trial enrollment and dosing completed (N=63) in less than nine months. Topline results expected in 2Q27 with BLA to follow by mid-2027
  • 04 Mar 2026 According to an Ocugen media release, the trial is nearing enrollment completion. Interim data expected in the third quarter 2026, followed by topline Phase 2/3 data in the second quarter 2027 in advance of the BLA submission.

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