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A randomized controlled phase III RECOVER trial of GS010 for Leber's Hereditary Optic Neuropathy (LHON)

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Trial Profile

A randomized controlled phase III RECOVER trial of GS010 for Leber's Hereditary Optic Neuropathy (LHON)

Status: Planning
Phase of Trial: Phase III

Latest Information Update: 09 Apr 2025

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At a glance

  • Drugs Lenadogene nolparvovec (Primary)
  • Indications Leber's hereditary optic atrophy
  • Focus Therapeutic Use
  • Acronyms RECOVER

Most Recent Events

  • 07 Apr 2025 According to GenSight Biologics media release, company is focusing on kicking off RECOVER Phase III trial.
  • 20 Jun 2024 According to GenSight Biologics media release, company remains on track to resume the early access program (AAC) for GS010 (LUMEVOQ) in France in Q3 2024. Company expected to start enrolling patients in H2 2025.
  • 04 Apr 2024 According to GenSight Biologics media release, companyreceived constructive feedback from the FDA regarding the design of the Phase III trial RECOVER, which had been previously shared with EMA (European Medicine Agency) and UK's MHRA (Medicines and Healthcare products Regulatory Agency). Company plans further discussions with the MHRA to ensure the quickest path towards a regulatory submission.

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