Press Release: Sanofi’s SAR446597 earns fast track designation in the US for geographic atrophy due to age-related macular degeneration
Sanofi’s SAR446597 earns fast track designation in the US for geographic atrophy due to age-related macular degeneration
- Designation earned for a one-time intravitreal gene therapy designed to inhibit two key complement cascade pathways
- Geographic atrophy is an advanced form of dry age-related macular degeneration, that can lead to permanent vision loss
Paris, July 16, 2025. The US Food and Drug Administration (FDA) has granted fast track designation to SAR446597, a one-time intravitreal gene therapy for the treatment of geographic atrophy (GA) due to age-related macular degeneration (AMD). The fast track designation process aims to facilitate the development and expedite the review of medicines to treat serious conditions and fill unmet medical need. The FDA created this process to help deliver important new drugs to patients earlier and it covers a broad range of serious illnesses.
SAR446597 delivers genetic material encoding two therapeutic antibody fragments that target and inhibit two critical components of the complement pathway: C1s in the classical pathway and factor Bb in the alternative pathway. This dual-targeting approach potentially offers clinical advantages by providing sustained complement suppression within the retinal microenvironment while significantly reducing treatment burden through elimination of frequent intravitreal injections. The therapy aims to address the underlying pathophysiology of complement-mediated retinal diseases through long-term expression of therapeutic proteins following a single intervention.
Sanofi plans to start a phase 1/2 study to evaluate the safety, tolerability, and efficacy of SAR446597.
Sanofi is also currently evaluating SAR402663, a one-time intravitreal gene therapy, in a phase 1/2 study (clinical study identifier: NCT06660667), for the treatment of patients with neovascular wet age-related macular degeneration.
About age-related macular degeneration and geographic atrophy
AMD is an acquired progressive degeneration of the retina that affects approximately 200 million people globally. Geographic atrophy is an advanced form of dry AMD. It is characterized by enlarging irreversible atrophic lesions due to degeneration of retinal cells leading to permanent vision loss in many patients. GA affects approximately 1 million people in the US, more than 2.5 million in Europe, and over 5 million people worldwide and has a profound impact on quality of life, including ability to read, drive and perform other daily activities.
About Sanofi in neurology
Our goal is to improve the lives of people with serious neuroinflammatory and neurodegenerative diseases. We are testing the bounds of clinical possibility to research therapies that may address multiple sclerosis (MS), chronic inflammatory demyelinating polyneuropathy (CIDP), Alzheimer’s Disease (AD), Parkinson’s disease (PD), Age-Related Macular Degeneration (AMD) and other neurological diseases for the people who need them most. Emerging scientific innovations and investments in ophthalmology have the potential to drive a new phase of growth for Sanofi. We are exploring innovative therapies in retinal diseases with unmet need especially where they connect with immune system conditions.
About Sanofi
Sanofi is an R&D driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. We apply our deep understanding of the immune system to invent medicines and vaccines that treat and protect millions of people around the world, with an innovative pipeline that could benefit millions more. Our team is guided by one purpose: we chase the miracles of science to improve people’s lives; this inspires us to drive progress and deliver positive impact for our people and the communities we serve, by addressing the most urgent healthcare, environmental, and societal challenges of our time.
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Media Relations
Sandrine Guendoul | +33 6 25 09 14 25 | sandrine.guendoul@sanofi.com
Evan Berland | +1 215 432 0234 | evan.berland@sanofi.com
Léo Le Bourhis | +33 6 75 06 43 81 | leo.lebourhis@sanofi.com
Victor Rouault | +33 6 70 93 71 40 | victor.rouault@sanofi.com
Timothy Gilbert | +1 516 521 2929 | timothy.gilbert@sanofi.com
Léa Ubaldi | +33 6 30 19 66 46 | lea.ubaldi@sanofi.com
Investor Relations
Thomas Kudsk Larsen |+44 7545 513 693 | thomas.larsen@sanofi.com
Alizé Kaisserian | +33 6 47 04 12 11 | alize.kaisserian@sanofi.com
Felix Lauscher | +1 908 612 7239 | felix.lauscher@sanofi.com
Keita Browne | +1 781 249 1766 | keita.browne@sanofi.com
Nathalie Pham | +33 7 85 93 30 17 | nathalie.pham@sanofi.com
Tarik Elgoutni | +1 617 710 3587 | tarik.elgoutni@sanofi.com
Thibaud Châtelet | +33 6 80 80 89 90 | thibaud.chatelet@sanofi.com
Yun Li | +33 6 84 00 90 72 | yun.li3@sanofi.com
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