Recent Updates
Recently added Catalysts

SAR402663

Phase 1

Neovascular Age-related Macular Degeneration | Monoclonal antibody | Ophthalmology |Sanofi|Last Updated: Nov 21, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedDouble-BlindCONTROLLEDDMC
Total Trials1
Total Enrollment66
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06660667A Safety and Efficacy Study of One-time SAR402663 in Adults With Neovascular Age-related Macular DegenerationPHASE1 RECRUITING 66 — — Nov 21, 2024Jun 30, 2031Nov 21, 202518 United States
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Incidence and severity of ocular treatment emergent adverse event (TEAEs)
Day 1 to Week 52
Incidence and severity of ocular treatment emergent serious adverse event (TESAEs)
Day 1 to Week 52
Incidence and severity of non-ocular TEAEs
Day 1 to Week 52
Incidence and severity of non-ocular TESAEs
Day 1 to Week 52
Number of participants with any clinically significant changes in laboratory variables
Day 1 to Week 52
Number of participants with any clinically significant changes in vital signs
Day 1 to Week 52
Secondary Endpoints
Percentage of participants not requiring supplemental anti-vascular endothelial growth factor (VEGF) therapy
Day 1 to Week 52 and Week 8 to Week 52
Annualized injection rates of anti-VEGF therapy
Day 1 to Week 52
Change from baseline in BCVA using the ETDRS letter score
Baseline, Week 52
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Part I - SAR402663 open-label (OL)EXPERIMENTALParticipants will receive a single dose of SAR402663 on Day 1. Multiple dose levels of SAR402663 will be evaluated in successive cohorts of participants.
Part II - SAR402663 Dose AEXPERIMENTALParticipants will receive a single dose of SAR402663 on Day 1.
Part II - SAR402663 Dose BEXPERIMENTALParticipants will receive a single dose of SAR402663 on Day 1.
Interventions
NameTypeDescription
SAR402663BIOLOGICALPharmaceutical form:Liquid formulation-Route of administration:Intravitreal injection
DiluentDRUGPharmaceutical form:Liquid solution-Route of administration:Intravitreal injection
Unlock Study Design Details
Eligibility Criteria
Age Range50 Years — 90 Years
SexALL
Healthy VolunteersNo
Study Sites18

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 a...

Countries:United States
Unlock Eligibility Criteria
Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT06660667primaryCompletionDate: changed
LOWMay 24, 2026NCT06660667studyFirstPostDate: changed