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

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.