Lumevoq demonstrates visual acuity improvement at 2 years in LHON
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Patients with Leber hereditary optic neuropathy treated with Lumevoq experienced sustained efficacy and safety after 2 years as part of the phase 3 REFLECT clinical trial, according to a press release from GenSight Biologics.
REFLECT is a special protocol assessment-designed, randomized, double-masked, placebo-controlled trial investigating Lumevoq (GS010; lenadogene nolparvovec) in 98 patients with vision loss due to Leber hereditary optic neuropathy (LHON). All patients received Lumevoq in the first affected eye and were then randomly assigned to receive either Lumevoq or placebo injection in the second eye.
Mean best corrected visual acuity statistically significantly improved in patients who received bilateral injections. After 2 years, BCVA changed –0.25 logMAR in the first eye for a gain of 13 ETDRS letters (P = .0006). In the second eye, BCVA changed –0.18 logMAR for a gain of nine ETDRS letters (P = .01).
In patients who received unilateral injections, BCVA changed –0.16 logMAR in the first eye for a gain of eight ETDRS letters (P = .02). BCVA in eyes that received placebo changed –0.10 logMAR for a gain of five ETDRS letters, but the difference was not statistically significant.
“The REFLECT trial’s demonstration of a sustained, significant and safe improvement in visual acuity for LHON patients treated bilaterally with Lumevoq provides additional impetus for our push to gain regulatory approval,” Bernard Gilly, CEO and co-founder of GenSight Biologics, said in the release. “Patients afflicted with LHON who are losing their sight deserve access to a treatment like Lumevoq.”
There were no serious ocular adverse events, and there were no treatment discontinuations due to adverse events.
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