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Randomized, Double-Masked, Sham-Controlled Clinical Trial to Evaluate the Efficacy of a Single Intravitreal Injection of GS010 in Subjects Affected for More Than 6 Months and To 12 Months by LHON Due to the G11778A Mutation in the ND4 Gene

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Trial Profile

Randomized, Double-Masked, Sham-Controlled Clinical Trial to Evaluate the Efficacy of a Single Intravitreal Injection of GS010 in Subjects Affected for More Than 6 Months and To 12 Months by LHON Due to the G11778A Mutation in the ND4 Gene

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 14 Jun 2023

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At a glance

  • Drugs Lenadogene nolparvovec (Primary)
  • Indications Leber's hereditary optic atrophy
  • Focus Registrational; Therapeutic Use
  • Acronyms REVERSE
  • Sponsors GenSight Biologics

Most Recent Events

  • 27 Apr 2023 Results from REVERSE, RESCUE, RESTORE and REFLECT; comparing visual acuity of Leber hereditary optic neuropathy (LHON) patients treated with lenadogene nolparvovec, presented at the 75th Annual Meeting of the American Academy of Neurology 2023
  • 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).
  • 06 Mar 2023 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 Q1 2024 as a result of an extension granted by the EMA for GenSight's responses to its Day 120 questions, to be followed shortly by the commercial launch in Europe.

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