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

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).