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BioWorld - Thursday, December 4, 2025
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Home » Further manufacturing delays cast doubt on Lumevoq despite sustained phase III efficacy
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Further manufacturing delays cast doubt on Lumevoq despite sustained phase III efficacy

March 15, 2023
By Caroline Richards
Patients with Leber hereditary optic neuropathy who received bilateral injections of Gensight Biologics SA’s Lumevoq (lenadogene nolparvovec) are continuing to see statistically significant visual improvements three years into the phase III REFLECT trial, but the missed primary endpoint at 1.5 years, along with a series of manufacturing mishaps, have left the gene therapy’s approval prospects uncertain.
BioWorld Clinical Ocular Gene therapy

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