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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: 28 Aug 2024

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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
  • Orphan Drug Status

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

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

Highest Development Phases

  • Phase III Retinal disorders
  • Phase I/II Leber congenital amaurosis; Retinitis pigmentosa

Most Recent Events

  • 26 Aug 2024 Ocugen announces Health Canada approval to initiate phase III limelight trial for OCU 400 in Retinitis Pigmentosa
  • 05 Aug 2024 Ocugen receives US FDA notification to initiate an Expanded Access Program (EAP) for Retinitis pigmentosa
  • 26 Apr 2024 Ocugen plans to submit BLA and MAA for Retinitis pigmentosa in 2026

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