Título / Title

EFFICACY, SAFETY, AND DURABILITY OF FARICIMAB IN DIABETIC MACULAR EDEMA: ONE-YEAR RESULTS FROM THE PHASE 3 YOSEMITE AND RHINE TRIALS

Introdução / Purpose

Faricimab a novel bispecific antibody designed to inhibit angiopoietin and VEGF-A, reduce vascular leakage and inflammation, promote vascular stability, and improve outcomes and durability beyond anti-VEGF monotherapy for DME.

Material e Método / Methods

Pts were randomized 1:1:1 to fari 6.0 mg Q8W, after 6 initial Q4W doses, fari 6.0 mg per personalized treat. interval (PTI) after 4 initial Q4W doses, or aflibercept 2.0 mg Q8W after 5 Q4W doses. The PTI is a protocol-driven regimen based on T&E, with dosing intervals adjusted in 4-week increments (Q4W up to Q16W) using prespecified BCVA and CST criteria. The primary efficacy endpoint was mean change in BCVA from baseline at 1 year, averaged over weeks 48, 52, and 56. Noninferiority in ITT population, followed by superiority in treat.-naïve pts, was assessed for each arm .

Resultados / Results

1891 pts were enrolled. Baseline characteristics were well balanced across treat. arms. Both trials met primary endpoint; mean BCVA gains from baseline at 1 y with faricimab Q8W (+10.7 and +11.8 ETDRS letters in Y and R, respectively) or faricimab PTI up to Q16W (+11.6 and +10.8 ETDRS letters) were noninferior to aflibercept Q8W (+10.9 and +10.3 ETDRS letters). In treat.-naïve pts, mean BCVA gains at 1 y were consistent with the ITT population and no faricimab arm showed superiority to aflibercept. Mean change in CST over 1 year consistently favored faricimab over aflibercept. Absence of protocol-defined DME (CST < 325 µm) and absence of IRF during y 1 were achieved by more pts treated with fari versus aflibercept. Notably, 52.8% (Y) and 51.0% (R) of pts in the fari PTI arm achieved Q16W dosing at week 52, while 73.8% and 71.1%, respectively, achieved ≥ Q12W dosing. Fari was well tolerated; IO inflammation event rates were low and there were no cases of vasculitis or occlusive retinitis.

Discussão e Conclusões / Conclusion

Faricimab Q8W or per PTI, offered noninferior vision gains vs aflibercept Q8W, while demonstrating improvements in anatomic outcomes and the potential for extended (up to Q16W) dosing at 1 y.

Palavras Chave

Faricimab
Diabetic Macular Edema
Retinal Degeneration
Retinal Diseases
Eye Diseases
Aflibercept
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents

Area

CLINICAL RETINA