Data demonstrate significance of Lumevoq treatment in patients with LHON
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An analysis from clinical trials and natural history studies showed a statistically significant difference in visual outcomes between Lumevoq-treated patients and untreated patients, according to a press release from GenSight Biologics.
In patients with Leber hereditary optic neuropathy, eyes treated with Lumevoq (GS010; lenadogene nolparvovec) showed progressive and sustained improvement from month 12 to month 52, while untreated eyes showed an “absence of recovery” over the same period. The difference became statistically significant at month 18 (P = .01). At month 48, the difference between the mean visual acuity in treated patients and untreated patients was statistically significant (P < .01) and clinically meaningful, with treated eyes experiencing +16.5 ETDRS letters, or – 0.33 logMAR.
The analysis included data from the phase 3 RESCUE and REVERSE trials as well as interim results from CLIN06, a long-term follow-up study, and a matched sample created from the REALITY registry study and 10 natural history studies.
“The findings are a gratifying outcome of our push to overcome a key challenge for assessing Lumevoq’s efficacy, namely the inability of sham eyes to act as a control group,” Bernard Gilly, co-founder and CEO of GenSight, said in the release. “We are excited to take this evidence — that Lumevoq modifies the disease outcome — forward into our conversations with national and regional authorities.”
GenSight filed a marketing authorization application for Lumevoq earlier this month, with a decision expected in the second half of 2021. The company also anticipates submitting a biologics license application to the FDA in the second half of 2021.
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