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GenSight Biologics expands trial of Leber's hereditary optic neuropathy treatment to include teenage patients

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GenSight Biologics announced that regulatory agencies and ethics committees in the United States, France and the United Kingdom have approved a protocol amendment to include teenage patients aged 15 to 18 years in its two ongoing phase 3 clinical trials of GS010.

According to a GenSight press release, the phase 3 RESCUE and REVERSE clinical trials are testing the use of GS010 in the treatment of Leber’s hereditary optic neuropathy.

“Given the brutality of the onset of vision loss and the neurodegenerative nature of the disease, we are thrilled to be able to consider all patients irrespective of their age,” Bernard Gilly, CEO of GenSight Biologics, said in the press release.

It is estimated that teenage patients may represent between 14% to 22% of all LHON patients. The trial was initially designed to include only adult patients.