TY - JOUR
T1 - Real-World Safety Outcomes with Brolucizumab in Neovascular Age-Related Macular Degeneration
T2 - Findings from the IRIS® Registry
AU - Zarbin, Marco A.
AU - MacCumber, Mathew W.
AU - Karcher, Helene
AU - Adiguzel, Eser
AU - Mayhook, Andrew
AU - LaPrise, Andrew
AU - Bilano, Ver L.
AU - Igwe, Franklin
AU - Ip, Michael S.
AU - Wykoff, Charles C.
N1 - Publisher Copyright:
© The Author(s) 2024.
PY - 2024/5
Y1 - 2024/5
N2 - Introduction: To assess real-world safety outcomes for adults with neovascular age-related macular degeneration (nAMD) treated with brolucizumab from the US-based IRIS® (Intelligent Research in Sight) Registry. Methods: In this retrospective study, 18,312 eyes (15,998 patients) treated with ≥ 1 intravitreal brolucizumab injections between 8 October 2019 (US launch date for brolucizumab) and 7 October 2021 were followed up for ≤ 2 years after first injection (index date). The study assessed the predefined incident ocular adverse events of intraocular inflammation (IOI), retinal vasculitis (RV), and retinal vascular occlusion (RO). Results: Overall, 614/18,312 eyes (3.4%) experienced any IOI, RV, and/or RO event. Median (interquartile range [IQR]) time to an event was 84 (42–167) days; 77.4% of events (475/614) occurred within 6 months after index date. Median (IQR) number of brolucizumab injections before an event was 2 (1–4). For eyes with an adverse event and visual acuity (VA) data (n = 406), median (IQR) change in Early Treatment of Diabetic Retinopathy Study (ETDRS) letters from pre-event VA was 0 (− 7 to + 5) at the 6-month follow-up; 50 eyes (12.3%) had a VA loss of 10 or more ETDRS letters. Risk of an event (hazard ratio [95% confidence interval]) was decreased in eyes from male patients (0.61 [0.53–0.71]), from older patients (0.83 [0.76–0.90]), from treatment-naive patients (0.51 [0.38–0.69]), and from patients who started brolucizumab in the second year after launch (0.68 [0.53–0.86] vs. first year). Conclusion: In this large real-world brolucizumab safety study, 3.4% of eyes experienced an IOI, RV, and/or RO event. Among eyes that experienced an adverse event for which VA data were available, median ETDRS vision change was 0 letters (IQR − 7 to + 5).
AB - Introduction: To assess real-world safety outcomes for adults with neovascular age-related macular degeneration (nAMD) treated with brolucizumab from the US-based IRIS® (Intelligent Research in Sight) Registry. Methods: In this retrospective study, 18,312 eyes (15,998 patients) treated with ≥ 1 intravitreal brolucizumab injections between 8 October 2019 (US launch date for brolucizumab) and 7 October 2021 were followed up for ≤ 2 years after first injection (index date). The study assessed the predefined incident ocular adverse events of intraocular inflammation (IOI), retinal vasculitis (RV), and retinal vascular occlusion (RO). Results: Overall, 614/18,312 eyes (3.4%) experienced any IOI, RV, and/or RO event. Median (interquartile range [IQR]) time to an event was 84 (42–167) days; 77.4% of events (475/614) occurred within 6 months after index date. Median (IQR) number of brolucizumab injections before an event was 2 (1–4). For eyes with an adverse event and visual acuity (VA) data (n = 406), median (IQR) change in Early Treatment of Diabetic Retinopathy Study (ETDRS) letters from pre-event VA was 0 (− 7 to + 5) at the 6-month follow-up; 50 eyes (12.3%) had a VA loss of 10 or more ETDRS letters. Risk of an event (hazard ratio [95% confidence interval]) was decreased in eyes from male patients (0.61 [0.53–0.71]), from older patients (0.83 [0.76–0.90]), from treatment-naive patients (0.51 [0.38–0.69]), and from patients who started brolucizumab in the second year after launch (0.68 [0.53–0.86] vs. first year). Conclusion: In this large real-world brolucizumab safety study, 3.4% of eyes experienced an IOI, RV, and/or RO event. Among eyes that experienced an adverse event for which VA data were available, median ETDRS vision change was 0 letters (IQR − 7 to + 5).
KW - Anti-vascular endothelial growth factor therapy
KW - Brolucizumab
KW - Intraocular inflammation
KW - Neovascular age-related macular degeneration
KW - Real-world evidence
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U2 - 10.1007/s40123-024-00920-3
DO - 10.1007/s40123-024-00920-3
M3 - Article
AN - SCOPUS:85188457667
SN - 2193-8245
VL - 13
SP - 1357
EP - 1368
JO - Ophthalmology and Therapy
JF - Ophthalmology and Therapy
IS - 5
ER -