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REFLECT phase III clinical trial for Lumevoq shows benefits for bilateral treatment in Leber Hereditary Optic Neuropathy.- GenSight Biologics

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Published:2nd Jul 2021
GenSight Biologics reported key efficacy and safety findings at 1.5 years (78 weeks) post-treatment in the REFLECT Phase III clinical trial for Lumevoq. The results show better visual acuity improvements from bilateral intravitreal injections of the gene therapy compared to a unilateral injection. The REFLECT trial is a randomized, double-masked, placebo-controlled Phase III trial involving 98 subjects with vision loss due to Leber Hereditary Optic Neuropathy (LHON) caused by a mutated ND4 mitochondrial gene; enrolled ND4 subjects had vision loss up to one year from onset.

At the primary time point of the analysis, 1.5 years after injection, mean best-corrected visual acuity (BCVA) in Lumevoq-treated eyes was statistically significantly better than baseline, whereas the improvement from baseline was not statistically significant in placebo eyes. Consistent with REVERSE2 and RESCUE3, unilaterally treated subjects showed a contralateral effect in their placebo-treated eye. The contralateral effect reduced the difference in the outcomes among Lumevoq and placebo-treated eyes, and consequently, the trial did not meet the pre-defined primary endpoint. The difference of the change from baseline in BCVA between the second affected Lumevoq and placebo-treated eyes was -0.05 LogMAR (+3 ETDRS letters equivalent; p=0.6080).

A dose effect, seen between bilaterally and unilaterally treated subjects, provides new evidence on Lumevoq efficacy. In each group, the BCVAs of both eyes improved from baseline in tandem, but with a higher treatment effect for bilaterally treated subjects . Responder analyses show that most of the subjects responded to treatment and confirm that bilateral injections provide better efficacy. The favorable safety profile of Lumevoq was confirmed. There was no study discontinuation related to systemic or ocular adverse event. There were no serious ocular adverse events.

Condition: Leber's Hereditary Optic Neuropathy
Type: drug

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