GenSight Biologics reported initial efficacy and safety results at 4 years a post-treatment administration in the REFLECT Phase III clinical trial with LUMEVOQ®? (GS010; lenadogene nolparvovec). The results show that four years after a one-time administration of the gene therapy, the visual acuity improvement has been sustained while maintaining a favorable safety profile.

Bilateral injection provides an additional effect compared to unilateral treatment, demonstrated across all analyses of visual acuity improvement and responder rates. The evolution of the visual acuity over time shows that visual improvement after lenadogene nol parvovec treatment was maintained over 4 years in all subjects, with the visual acuity of bilateral injected patients remaining better than that of patients who received a unilateral injection. This difference has been observed since Year 1.5. Compared against nadir (i.e., the worst BCVA recorded from baseline to Year 4), average visual acuity for all LUMEVOQ-treated eyes increased beyond the +15 letter threshold that conventionally defines clinically meaningful improvement.

The improvement of placebo eyes highlights the consistent contralateral treatment effect observed in all clinical trials (also documented in sham-treated eyes in the REVERSE1 and RESCUE2 trials).