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Clinical Trial
. 2025 Jan-Feb;14(1):100142.
doi: 10.1016/j.apjo.2025.100142. Epub 2025 Jan 14.

Efficacy, durability and safety of faricimab for patients with neovascular age-related macular degeneration: 48-week results from the phase 3 LUCERNE China subpopulation

Wenjun Zou  1 , Qin Jiang  2 , Yanling Wang  3 , Wenbin Wei  4 , Xiaodong Sun  5 , Karen Basu  6 , Qiuyu Chen  7 , Aachal Kotecha  8 , Sijing Li  9 , Ruyuan Liu  10 , Vaibhavi Patel  11 , Youxin Chen  12
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Free article
Clinical Trial

Efficacy, durability and safety of faricimab for patients with neovascular age-related macular degeneration: 48-week results from the phase 3 LUCERNE China subpopulation

Wenjun Zou et al. Asia Pac J Ophthalmol (Phila). 2025 Jan-Feb.
Free article

Abstract

Purpose: To evaluate the efficacy, durability and safety of intravitreal faricimab versus aflibercept over 48 weeks in patients with neovascular age-related macular degeneration (nAMD) from the LUCERNE China subpopulation.

Design: LUCERNE (NCT03823300) was a phase 3 global, double-masked, active comparator-controlled trial. The China subpopulation comprised patients from mainland China, Taiwan and Hong Kong.

Methods: Treatment-naïve patients aged ≥50 years with nAMD were randomized 1:1 to receive faricimab 6.0 mg up to every 16 weeks (Q16W) based on prespecified disease criteria after four initial Q4W doses or aflibercept 2.0 mg Q8W after three initial Q4W doses. The primary endpoint was mean change from baseline in best-corrected visual acuity (BCVA) averaged over weeks 40 to 48. Anatomical, durability and safety outcomes were also evaluated.

Results: The China subpopulation comprised 119 patients (faricimab: n = 59, aflibercept: n = 60). At weeks 40 to 48, adjusted mean (95% confidence interval [CI]) BCVA letter gains from baseline were +9.7 (7.4 to 12.0) and +9.8 (7.5 to 12.1) with faricimab and aflibercept, respectively. Central subfield thickness was reduced from baseline by weeks 40 to 48 in both arms, with an adjusted mean (95% CI) change of -145.4 µm (-156.2 to -134.6) and -156.5 µm (-167.3 to -145.7) for faricimab and aflibercept, respectively. By week 48, 87.3% of the patients were on extended ≥Q12W faricimab dosing. Faricimab was well tolerated with no new safety signals.

Conclusions: Faricimab up to Q16W showed durable efficacy in the LUCERNE China subpopulation, consistent with global findings. Faricimab may reduce treatment burden for patients with nAMD in China, without compromising efficacy.

Keywords: Angiopoietin-2; China; Faricimab; Neovascular age-related macular degeneration; Vascular endothelial growth factor-A.

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Conflict of interest statement

Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Xiaodong Sun, Karen Basu reports financial support was provided by F. Hoffmann-La Roche Ltd. Qiuyu Chen, Sijing Li, Ruyuan Liu reports financial support was provided by Roche R&D Center China Ltd. Aachal Kotecha, Vaibhavi Patel reports financial support was provided by Roche Products Ltd. Youxin Chen reports financial support was provided by F. Hoffmann-La Roche Ltd. Xiaodong Sun reports a relationship with Alcon that includes: consulting or advisory. Xiaodong Sun reports a relationship with Allergan that includes: consulting or advisory. Xiaodong Sun reports a relationship with Bayer Healthcare that includes: consulting or advisory. Xiaodong Sun reports a relationship with Carl Zeiss Meditec Inc that includes: consulting or advisory. Xiaodong Sun reports a relationship with Innovent Biologics, Inc. that includes: consulting or advisory. Xiaodong Sun reports a relationship with Chengdu Kanghong Biotechnology Inc that includes: consulting or advisory. Xiaodong Sun reports a relationship with Novartis that includes: consulting or advisory. Youxin Chen reports a relationship with AbbVie Inc that includes: consulting or advisory. Youxin Chen reports a relationship with Bayer Healthcare that includes: consulting or advisory. Youxin Chen reports a relationship with Novartis that includes: consulting or advisory. If there are other authors, they declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

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