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OCU 400

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Drug Profile

OCU 400

Alternative Names: AAV-NR2E3; AAV5-hNR2E3; NR2E3-AAV; OCU-400

Latest Information Update: 13 Jun 2025

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At a glance

  • Originator Schepens Eye Research Institute
  • Developer Ocugen; Schepens Eye Research Institute
  • Class Eye disorder therapies; Gene therapies
  • Mechanism of Action Gene transference; NR2E3 protein replacements
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Retinitis pigmentosa; Leber congenital amaurosis; Retinal disorders
  • New Molecular Entity No

Highest Development Phases

  • Phase III Retinitis pigmentosa
  • Phase I/II Leber congenital amaurosis
  • No development reported Retinal disorders

Most Recent Events

  • 05 Jun 2025 Ocugen announces Signing of Binding Term Sheet with an undisclosed organization for the License of OCU 400 for Retinitis pigmentosa in South Korea
  • 03 Feb 2025 Ocugen announces intention to launch OCU 400 for Retinitis pigmentosa in the US and the European Union by 2027
  • 03 Feb 2025 The European Commission has provides a positive opinion from the European Medicines Agency’s (EMA) Committee for Advanced Therapies (CAT) for OCU 400 Advanced Therapy Medicinal Product (ATMP) classification

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