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An Open Label Dose Escalation Clinical Trial to Evaluate the Safety and the Tolerability of GS010 (rAAV2/2-ND4) in Patients With Leber Hereditary Optic Neuropathy Due to Mutations in the Mitochondrial NADH Dehydrogenase 4 Gene

Trial Profile

An Open Label Dose Escalation Clinical Trial to Evaluate the Safety and the Tolerability of GS010 (rAAV2/2-ND4) in Patients With Leber Hereditary Optic Neuropathy Due to Mutations in the Mitochondrial NADH Dehydrogenase 4 Gene

Status: Completed
Phase of Trial: Phase I/II

Latest Information Update: 16 Mar 2023

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At a glance

  • Drugs Lenadogene nolparvovec (Primary)
  • Indications Leber's hereditary optic atrophy
  • Focus Adverse reactions; First in man
  • Acronyms REVEAL Study
  • Sponsors GenSight Biologics
  • Most Recent Events

    • 09 Mar 2023 According to a GenSight Biologics media release, company announced publication of a peer-reviewed article in American Journal of Ophthalmology on pooled safety analysis of lenadogene nolparvovec from five clinical studies (REVEAL, RESCUE, REVERSE, RESTORE and REFLECT).
    • 24 Jan 2022 According to a GenSight Biologics media release, the review of the European Marketing Authorisation Application for LUMEVOQ is ongoing, with the decision from the CHMP expected in Q4 2022.
    • 29 Jul 2021 According to a GenSight Biologics media release, Following a delay in manufacturing validation batches of LUMEVOQ as a consequence of the US Defense Production Act (DPA), The EU marketing authorization is expected in H1 2022.
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