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Introduction <p>To assess the efficacy, durability, and safety of faricimab compared with aflibercept over 1&#xa0;year in patients with diabetic macular edema (DME) from the China RHINE subpopulation.</p> Methods <p>RHINE was a phase 3 global, active comparator-controlled trial. The China RHINE subpopulation included patients from mainland China, Hong Kong, and Taiwan. Patients with DME were randomized to faricimab 6.0&#xa0;mg every 8&#xa0;weeks (Q8W), faricimab 6.0&#xa0;mg treat-and-extend (T&amp;E), or aflibercept 2.0&#xa0;mg Q8W up to week 100. The mean change from baseline in best-corrected visual acuity (BCVA) averaged over weeks 48–56 was the primary end point. Anatomic, durability, and safety outcomes were also assessed.</p> Results <p>In China RHINE subpopulation at weeks 48–56, adjusted mean BCVA change from baseline was +13.2, +11.5, and +9.2 letters with faricimab Q8W (<i>n</i> = 51), faricimab T&amp;E (<i>n</i> = 49), and aflibercept Q8W (<i>n</i> = 52), respectively. More patients treated with faricimab achieved absence of DME or intraretinal fluid, and 75% achieved &gt; Q12W dosing with faricimab T&amp;E by week 52. Faricimab was well-tolerated; there were no new safety signals.</p> Conclusions <p>Visual and anatomic improvements with faricimab in the China RHINE subpopulation were in keeping with the global findings. Faricimab offers durable treatment for patients with DME in China.</p> Trial registration <p>RHINE (NCT03622593).</p>

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Efficacy, Durability, and Safety of Faricimab for Diabetic Macular Edema: 1-Year Results from the China RHINE Subpopulation

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年4月10日

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  • Xiaorong Li,
  • Xiaoling Liu,
  • Qin Jiang,
  • Zhifeng Wu,
  • Mei Han,
  • Qiuyu Chen,
  • Oluwatobi O. Idowu,
  • Ruyuan Liu,
  • Wenxin Liu,
  • Jeffrey R. Willis,
  • Xiaodong Sun

摘要

Introduction

To assess the efficacy, durability, and safety of faricimab compared with aflibercept over 1 year in patients with diabetic macular edema (DME) from the China RHINE subpopulation.

Methods

RHINE was a phase 3 global, active comparator-controlled trial. The China RHINE subpopulation included patients from mainland China, Hong Kong, and Taiwan. Patients with DME were randomized to faricimab 6.0 mg every 8 weeks (Q8W), faricimab 6.0 mg treat-and-extend (T&E), or aflibercept 2.0 mg Q8W up to week 100. The mean change from baseline in best-corrected visual acuity (BCVA) averaged over weeks 48–56 was the primary end point. Anatomic, durability, and safety outcomes were also assessed.

Results

In China RHINE subpopulation at weeks 48–56, adjusted mean BCVA change from baseline was +13.2, +11.5, and +9.2 letters with faricimab Q8W (n = 51), faricimab T&E (n = 49), and aflibercept Q8W (n = 52), respectively. More patients treated with faricimab achieved absence of DME or intraretinal fluid, and 75% achieved > Q12W dosing with faricimab T&E by week 52. Faricimab was well-tolerated; there were no new safety signals.

Conclusions

Visual and anatomic improvements with faricimab in the China RHINE subpopulation were in keeping with the global findings. Faricimab offers durable treatment for patients with DME in China.

Trial registration

RHINE (NCT03622593).