GenSight Announces Vision Improvement Maintained 4 Yrs After Treatment With LUMEVOQ Gene Therapy

(RTTNews) - GenSight Biologics (GSGTF) said Monday that Leber Hereditary Optical Neuropathy subjects treated with LUMEVOQ continued to experience significantly improved vision four years after a single injection of the gene therapy.

The findings came from RESTORE (CLIN06), the long-term follow-up study to which participants in the RESCUE and REVERSE Phase III pivotal trials were invited.

When RESTORE subjects enrolled in the study, 2 years after the one-time injection, they had already experienced clinically meaningful improvements relative to the lowest point of their best-corrected visual acuity (BCVA): +18.8 ETDRS letters equivalent in their LUMEVOQ-treated eyes and +17.3 letters equivalent in their sham-treated eyes.

The company noted that four years after treatment, the bilateral improvement from nadir was sustained, with LUMEVOQ-treated eyes achieving a mean improvement against nadir of +22.5 letters equivalent and sham-treated eyes demonstrating a mean improvement of +20.5 letters equivalent.

The review of the European Marketing Authorization Application for LUMEVOQ is ongoing, with the decision from the CHMP expected in fourth-quarter 2022.