Efficacy and Safety of Bilateral Intravitreal Injection of GS010: A Randomized, Double-Masked, Placebo-Controlled Trial in Subjects Affected With G11778A ND4 Leber Hereditary Optic Neuropathy for Up to One Year
Phase of Trial: Phase III
Latest Information Update: 07 Feb 2019
At a glance
- Drugs GS 010 (Primary)
- Indications Leber's hereditary optic atrophy
- Focus Registrational; Therapeutic Use
- Acronyms REFLECT
- Sponsors GenSight Biologics
- 13 Sep 2018 According to a GenSight Biologics media release, based on the Special Protocol Assessment (SPA) and interim results of the study, BLA submission in the US is targeted for H2 2020.
- 13 Sep 2018 According to a GenSight Biologics media release, this trial is covered by a Special Protocol Assessment (SPA) with the FDA.
- 05 Apr 2018 Status changed from not yet recruiting to recruiting.