GenSight Biologics Provides Updates about GS010/LUMEVOQ® Early Access Programs and the Ongoing REVISE Study

09 Mar 2026 07:30 CET

Regulatory News:

GenSight Biologics (Euronext: SIGHT, ISIN: FR0013183985, PEA-PME eligible), a biopharma company focused on developing and commercializing innovative gene therapies for retinal neurodegenerative diseases and central nervous system disorders, today provided updates on the GS010/LUMEVOQ^® early access programs currently underway and the ongoing dose-ranging study REVISE. GS010/LUMEVOQ^® is the Company’s candidate gene therapy in clinical development as a treatment for Leber Hereditary Optic Neuropathy (LHON) caused by a mutated ND4 mitochondrial gene.¹

France: Approval of Applications in Named Patient Early Access (AAC) Program; Continuing Enrollment in the REVISE Study

Following the authorization of the AAC program by the national medicines safety agency ANSM in December 2025, individual applications that were submitted in February were approved today. The Company is completing the administrative steps to finalize delivery of the product to the 15-20 National Hospital, where the treatments have been scheduled for mid- and late March.

The dose-ranging study REVISE is progressing on schedule, with the first patient treated in February and the second patient expected to be enrolled over the next few weeks.

Israel: Second Patient for Paid Named Patient Program

A second patient in Israel was approved for treatment under the Paid Named Patient Program by the Israeli Ministry of Health (IMOH). The Company is supporting the logistical activities to ship and administer the treatment by next quarter.

USA: Second Individual IND Cleared for Expanded Access Program

A second US patient will be treated as part of the GS010/LUMEVOQ^® expanded access program after the FDA cleared the single patient IND for the patient in January 2026. The agency’s decision follows the treatment last year of the patient whose individual patient IND was cleared in October 2025.

First payments for the treatments in France are expected to be received before the end of March. Although the Company is unable to predict the precise timing of the treatments and payments in the various early access programs in the coming year, the expected revenues in the aggregate, are expected to be sufficient to, at a minimum, ensure the Company’s operational continuity beyond the February 2026 cash horizon indicated in the January 8th press release and, in the ordinary course of business, through 2026. Beyond this baseline, the Company will continue its funding operations, on a dilutive and non-dilutive basis, to further extend the cash runway and in particular to finance the RECOVER Phase III trial.

About GenSight Biologics

GenSight Biologics S.A. is a clinical-stage biopharma company focused on developing and commercializing innovative gene therapies for retinal neurodegenerative diseases and central nervous system disorders. GenSight Biologics' pipeline leverages two core technology platforms, the Mitochondrial Targeting Sequence (MTS) and optogenetics, to help preserve or restore vision in patients suffering from blinding retinal diseases. GenSight Biologics' lead product candidate, GS010 (lenadogene nolparvovec) is in Phase III in Leber Hereditary Optic Neuropathy (LHON), a rare mitochondrial disease that leads to irreversible blindness in teens and young adults. GS010 is currently in clinical development, has not to date been granted marketing authorization in France or any other jurisdiction, and is therefore not available commercially. Using its gene therapy-based approach, GenSight Biologics' product candidates are designed to be administered in a single treatment to each eye by intravitreal injection to offer patients a sustainable functional visual recovery.

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GenSight Biologics
Chief Financial Officer
Jan Eryk Umiastowski
jeumiastowski@gensight-biologics.com