Press Release: Sanofi's SAR446597 earns fast track designation in the US for geographic atrophy due to age-related macular degeneration

Core Insights - The FDA has granted fast track designation to Sanofi's SAR446597, a one-time intravitreal gene therapy for geographic atrophy due to age-related macular degeneration [1][6] - This designation aims to expedite the development and review of treatments for serious conditions with unmet medical needs [1] Product Details - SAR446597 delivers genetic material encoding two therapeutic antibody fragments that inhibit critical components of the complement pathway, potentially offering sustained complement suppression and reducing treatment burden [2] - The therapy targets the underlying pathophysiology of complement-mediated retinal diseases through long-term expression of therapeutic proteins after a single intervention [2] Clinical Development - Sanofi plans to initiate a phase 1/2 study to evaluate the safety, tolerability, and efficacy of SAR446597 [3] - Additionally, Sanofi is evaluating another gene therapy, SAR402663, for neovascular wet age-related macular degeneration in a phase 1/2 study [3] Market Context - Age-related macular degeneration affects approximately 200 million people globally, with geographic atrophy impacting around 1 million people in the US, over 2.5 million in Europe, and more than 5 million worldwide [3] - Geographic atrophy leads to permanent vision loss and significantly affects quality of life, including daily activities such as reading and driving [3] Company Focus - Sanofi aims to improve the lives of individuals with serious neuroinflammatory and neurodegenerative diseases, including age-related macular degeneration [4] - The company is exploring innovative therapies in retinal diseases, particularly those connected to immune system conditions, as part of its growth strategy [4]