Lumevoq shows sustained efficacy, safety 4 years after one-time LHON treatment
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Key takeaways:
- The gene therapy demonstrated sustained efficacy after one injection in patients with Leber hereditary optic neuropathy.
- The safety profile at 4 years was favorable, with no serious ocular adverse events.
Lumevoq demonstrated sustained efficacy and a positive safety profile at 4 years after a one-time injection of the gene therapy in patients with Leber hereditary optic neuropathy, according to a press release from GenSight Biologics.
The phase 3 randomized, double-masked, placebo-controlled REFLECT clinical trial included 98 patients with Leber hereditary optic neuropathy (LHON) caused by a mutated ND4 mitochondrial gene. All patients received an intravitreal injection of Lumevoq (lenadogene nolparvovec) in one eye while the second eye was randomly assigned to receive either Lumevoq (48 patients) or placebo (50 patients).
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Seventy-three percent of bilaterally treated patients experienced a clinically meaningful improvement of at least –0.3 logMAR (+15 ETDRS letters) from their nadir, defined as the worst best corrected visual acuity from baseline to year 4. The average visual acuity for all eyes treated with the gene therapy improved “beyond the +15 letter threshold that conventionally defines clinically meaningful improvement,” according to the release.
At 4 years, patients who received bilateral Lumevoq injections experienced a mean change of –0.4 logMAR (+20 ETDRS letters) in the first affected eye and –0.34 logMAR (+17 ETDRS letters) in the second affected eye vs. nadir. Patients who received a unilateral Lumevoq injection experienced a mean change of –0.38 logMAR (+19 ETDRS letters) in the Lumevoq eye and –0.27 logMAR (+14 ETDRS letters) in the placebo eye, demonstrating a contralateral treatment effect.
Safety was comparable between bilaterally and unilaterally treated patients at 4 years. The main ocular adverse event was mild and treatable intraocular inflammation, with no serious ocular adverse events reported.
“The sustained effect on vision, as observed in the REFLECT trial, is a crucial piece of the Lumevoq story for patients, physicians and health authorities,” Laurence Rodriguez, CEO of GenSight Biologics, said in the release. “The durable impact from a single administration differentiates gene therapy from other treatment modalities, facilitating patient adherence and improving quality of life.”
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