PHARMACOVIGILANCE STUDY OF FARICIMAB, AFLIBERCEPT, AND RANIBIZUMAB IN NAMD AND DME: FAERS-BASED INSIGHTS ON OCULAR ADVERSE EVENTS
Author(s)
Ahmead S. Baljoon, BS, MS, PhD1, Diaby Karam2, Askal Ayalew Ali, PhD3, Islam Eljilany, BSc, MASc, Phd4, Sandra Suther, BS, MS, PhD5, Fahad Nawar Alharthi, BS, MS6, Nawaf Saeed Alqurashi, BS, MS7, Matthew Dutton, BS, MS, PhD5.
1Pharmacoeconomics department, Makkah Health Cluster-MOH Saudi Arabia, Makkah, Saudi Arabia, 2University of Florida, USA, 3Florida A & M University, Tallahassee, FL, USA, 4Moffit cancer center, Tampa, FL, USA, 5Florida A&M University, Tallahassee, FL, USA, 6Makkah Health Cluster-MOH Saudi Arabia, Makkah, Saudi Arabia, 7Makkah Health Cluster Alnoor Specialist Hospital, Makkah, Saudi Arabia.
1Pharmacoeconomics department, Makkah Health Cluster-MOH Saudi Arabia, Makkah, Saudi Arabia, 2University of Florida, USA, 3Florida A & M University, Tallahassee, FL, USA, 4Moffit cancer center, Tampa, FL, USA, 5Florida A&M University, Tallahassee, FL, USA, 6Makkah Health Cluster-MOH Saudi Arabia, Makkah, Saudi Arabia, 7Makkah Health Cluster Alnoor Specialist Hospital, Makkah, Saudi Arabia.
OBJECTIVES: Neovascular age-related macular degeneration (nAMD) and diabetic macular edema (DME) are major retinal diseases commonly treated with intravitreal anti-vascular endothelial growth factor (anti-VEGF) agents. Because repeated injections may be associated with ocular adverse events, this study aimed to identify and compare ocular adverse-event signals associated with faricimab, aflibercept, and ranibizumab using the FDA Adverse Event Reporting System (FAERS).
METHODS: • Study design: Retrospective pharmacovigilance study. • Data source: FAERS through OpenVigil 2.1. • Time period: Q4/2003 or Jan 1, 2004 to Q2/2024 or July 30, 2024. • Drugs: Faricimab, aflibercept, ranibizumab, including brand/generic search terms. • Events: Ocular adverse events classified by MedDRA PTs and grouped into 12 SMQs. • Signal detection: ROR and BCPNN/IC approach, with a minimum of 3 reports and signal thresholds.
RESULTS: • AERS included 12,636,115 adverse-event reports during the study period. • Among these, 2,879 reports involved faricimab, 28,173 involved aflibercept, and 24,742 involved ranibizumab. • Overall, 79 moderate-to-strong ocular adverse drug reaction signals were identified across the three anti-VEGF agents. Aflibercept had the highest number of signals (70), followed by ranibizumab (69) and faricimab (43).
CONCLUSIONS: This FAERS-based pharmacovigilance analysis identified distinct ocular safety-signal patterns among faricimab, aflibercept, and ranibizumab. Faricimab was mainly associated with inflammatory ocular signals, whereas aflibercept and ranibizumab showed stronger associations with lens, infection, vitreous, and retinal structural events. Further clinical and mechanistic studies are needed to confirm these signals and determine their clinical relevance.
METHODS: • Study design: Retrospective pharmacovigilance study. • Data source: FAERS through OpenVigil 2.1. • Time period: Q4/2003 or Jan 1, 2004 to Q2/2024 or July 30, 2024. • Drugs: Faricimab, aflibercept, ranibizumab, including brand/generic search terms. • Events: Ocular adverse events classified by MedDRA PTs and grouped into 12 SMQs. • Signal detection: ROR and BCPNN/IC approach, with a minimum of 3 reports and signal thresholds.
RESULTS: • AERS included 12,636,115 adverse-event reports during the study period. • Among these, 2,879 reports involved faricimab, 28,173 involved aflibercept, and 24,742 involved ranibizumab. • Overall, 79 moderate-to-strong ocular adverse drug reaction signals were identified across the three anti-VEGF agents. Aflibercept had the highest number of signals (70), followed by ranibizumab (69) and faricimab (43).
CONCLUSIONS: This FAERS-based pharmacovigilance analysis identified distinct ocular safety-signal patterns among faricimab, aflibercept, and ranibizumab. Faricimab was mainly associated with inflammatory ocular signals, whereas aflibercept and ranibizumab showed stronger associations with lens, infection, vitreous, and retinal structural events. Further clinical and mechanistic studies are needed to confirm these signals and determine their clinical relevance.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
RWD33
Topic
Epidemiology & Public Health, Methodological & Statistical Research, Real World Data & Information Systems
Topic Subcategory
Health & Insurance Records Systems
Disease
Sensory System Disorders (Ear, Eye, Dental, Skin), Systemic Disorders/Conditions (Anesthesia, Auto-Immune Disorders (n.e.c.), Hematological Disorders (non-oncologic), Pain)