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A Phase 2/3 pivotal confirmatory clinical trial for OCU410ST

Trial Profile

A Phase 2/3 pivotal confirmatory clinical trial for OCU410ST

Status: Planning
Phase of Trial: Phase II/III

Latest Information Update: 25 Apr 2025

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At a glance

  • Drugs OCU 410 (Primary)
  • Indications Stargardt disease
  • Focus Registrational; Therapeutic Use
  • Most Recent Events

    • 08 Apr 2025 According to an Ocugen media release, Dr. Shankar Musunuri, Chairman, Chief Executive Officer, and Co-founder of Ocugen will participate in a panel addressing the journey of commercializing Advanced Therapy Medicinal Products (ATMPs) including OCU400 for retinitis pigmentosa, OCU410 for geographic atrophy and OCU410ST for Stargardt disease, at the 2025 Cell & Gene Meeting on the Mediterranean being held April 15-17, 2025 at the Rome Cavalieri in Rome, Italy.
    • 05 Mar 2025 According to Ocugen media release, EMA granted OMPD for OCU410ST for the treatment of ABCA4-associated retinopathies including Stargardt disease, retinitis pigmentosa 19 (RP19), and cone-rod dystrophy 3 (CORD3). The EC provided a positive opinion from the EMA's CAT for OCU410ST ATMP classification.
    • 05 Mar 2025 New trial record

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