This is a Phase 1/Phase 2 multicenter study to evaluate the safety and efficacy of a one-time single-eye intravitreal dose of SAR402663 in participants with neovascular age-related macular degeneration.

Participants will be enrolled in one of 2 parts:

• In Part I (dose escalation), multiple dose levels of SAR402663 will be evaluated in successive cohorts of participants
• In Part II (dose expansion), participants will be randomized to receive one of two dose levels selected based on data from Part I. Participants, investigators and outcomes assessors will be masked to dose.

After receiving one-time dose of SAR402663, participants will undergo regular assessments over 12 months. Following this, participants will enter an extended follow-up (EFU) phase for the assessment of safety and durability of clinical activity of SAR402663 through Year 5.

Inclusion Criteria:

• Between 50 and 90 years of age
• Participants with diagnosis of macular neovascularization secondary to age-related macular degeneration (nAMD)
• Study eye with best corrected visual acuity (BCVA) ETDRS Snellen equivalent for dose escalation (Part I) between 20/32 and 20/400 and for expansion (Part II) between 20/25 and 20/200
• Current or previous use of anti-vascular endothelial growth factor (VEGF) treatment in the study eye
• Demonstrated a response to anti-VEGF treatment

Exclusion Criteria:

• Any condition in the study eye that may prevent visual acuity improvement or interfere with ocular safety or efficacy assessments
• History of active ocular infection in the study eye in 6 months prior to screening
• Active uncontrolled glaucoma in the study eye
• History of uveitis in either eye
• Current use of ocular corticosteroids in the study eye
• Previous gene therapy
• Any significant poorly controlled illness that would preclude study compliance and follow up

The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.

Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Part I is an open-label study. Part II is partially masked in which participants, Investigators, and outcomes assessors including reading center (RC) are masked to study intervention. The Sponsor is not masked. Masking will be maintained until all participants reach 52 weeks of follow up after SAR402663 dose.