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Baluretgene parvec - Ocugen

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Drug Profile

Baluretgene parvec - Ocugen

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

Latest Information Update: 16 Jul 2026

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At a glance

  • Originator Schepens Eye Research Institute
  • Developer Ocugen
  • 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

Most Recent Events

  • 13 Jul 2026 Ocugen enters into binding term sheet with Roots Pharmaceutical to license Baluretgene parvec for Retinitis pigmentosa in the Middle East and North Africa
  • 05 May 2026 Ocugen plans to submit two Biologics License Application (BLA) application by 2027
  • 05 May 2026 Ocugen expects completion of the BLA submission for Retinal pigmentosa by the second quarter of 2027

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