GenSight Biologics presents new scientific information from gene therapies LUMEVOQ® and GS030 on the American Academy of Ophthalmology 2021 convention

PARIS–(BUSINESS WIRE) – Regulatory news:

GenSight Biologics (Euronext: SIGHT, ISIN: FR0013183985, PEA-PME eligible), a biopharmaceutical company focused on developing and commercializing innovative gene therapies for retinal neurodegenerative and central nervous system disorders, today announced clinical data on the gene therapies LUMEVOQ® and GS030 will be presented at the American Academy of Ophthalmology (AAO) 125th Annual Meeting in New Orleans, Louisiana November 12-15, 2021.

Retina Subspecialty Day @ American Academy of Ophthalmology (AAO)

November 12, 2021

Morial Convention Center, New Orleans

José-Alain Sahel, MD, Co-Founder of GenSight Biologics and the Institut de la Vision (Sorbonne-Université / Inserm / CNRS), Paris, France, and Distinguished Professor and Chairman of the Department of Ophthalmology at the University of Pittsburgh School of Medicine, Pittsburgh, PA, USA, will discuss reported signs of efficacy in a second patient with retinitis pigmentosa treated with GS030 in the Phase I / IIa PIONEER study. A first case report was published in Nature Medicine in May 2021.

“Optogenetics in the Clinic: Safety and Efficacy Updates for the PIONEER Phase I / II Clinical Trial”

• Oral presentation by José-Alain Sahel, MD

• Session: RET09 – Section VII: Late Developments, Part I

• Venue: The Great Hall

• Friday, November 12, 2021, 3:11 p.m. – 3:16 p.m. CDT

American Academy of Ophthalmology (AAO)

12-15 November 2021

Morial Convention Center, New Orleans

Nancy J. Newman, MD, LeoDelle Jolley Professor of Ophthalmology and Neurology at Emory University School of Medicine in Atlanta, GA, USA, and International Coordinating Investigator of the REFLECT Phase III trial of LUMEVOQ® will be the results of REFLECT. – Study discussing study in the context of Liver Hereditary Optic Neuropathy (LHON) Natural History and the other two clinical studies RESCUE and REVERSE.

“The phase 3 REFLECT study: efficacy and safety of bilateral gene therapy for LHON”

• Oral presentation by Nancy Newman, MD

• Abstract number: PA050

• Venue: Room 255-257

• Monday, November 15, 2021, 8:48 a.m. – 8:55 a.m. CDT

Sean P. Donahue, MD, PhD, Coleman Professor and Vice Chairman of Clinical Affairs and Chief of the Department of Pediatric Ophthalmology at Vanderbilt Children’s Hospital in Nashville, TN, and International Principal Investigator in the REFLECT Phase III trial of LUMEVOQ ®, will discuss the results of 6 patients affected by ND4 LHON who were bilaterally treated with LUMEVOQ® in an FDA-approved compassionate use protocol.

“First results of bilateral gene therapy for the LHON 11778 mutation in a compassionate use protocol”

• Poster presentation by Sean Donahue, MD, PhD

• Abstract number: PO014

• Saturday, November 13, 2021, 12:45 p.m. – 12:50 p.m. CDT

About GenSight Biologics

GenSight Biologics SA is a clinical-stage biopharmaceutical company focused on developing and commercializing innovative gene therapies for retinal neurodegenerative and central nervous system disorders. GenSight Biologics’ pipeline leverages two core technology platforms, Mitochondrial Targeting Sequence (MTS) and Optogenetics, to maintain or restore vision in patients with blind retinal diseases. GenSight Biologics’ lead product candidate, LUMEVOQ® (GS010; lenadogenic nolparvovec), has been submitted for marketing authorization in Europe for the treatment of Liver Hereditary Optic Neuropathy (LHON), a rare mitochondrial disease that primarily affects adolescents and young adults and causes irreversible blindness . GenSight Biologics’ product candidates, with their gene therapy-based approach, are designed to be administered to each eye in a single treatment by intravitreal injection to provide patients with sustained functional restoration of vision.