(News Bulletin 247) – GenSight Biologics today announces efficacy and safety results at 3 years post-injection of Lumevoq in the REFLECT phase III clinical trial.
The results show the maintenance of the efficacy and tolerance of a bilateral intravitreal injection of gene therapy with a significant improvement in visual acuity.
‘The benefit in patients treated bilaterally suggests that injection into both eyes may be the best option for LHON patients with the ND4 mutation,’ comments Dr. Nancy J. Newman, professor and principal investigator of REFLECT.
These results reinforce those observed two years after treatment administration, which were reported in December 2021, and 1.5 years after treatment administration, reported in June 2021.
REFLECT patients will be followed up to 5 years after injection to monitor the efficacy and tolerance of lenadogene nolparvovec over time.
‘This gene therapy represents real hope for patients with this devastating blinding disease. These data will provide important support for the review of our dossier by the EMA,” adds Bernard Gilly, Managing Director of GenSight Biologics.
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