Título / Title

EFFICACY, SAFETY AND DURABILITY OF FARICIMAB IN NEOVASCULAR AGE-RELATED MACULAR DEGENERATION: WEEK 48 RESULTS FROM THE PHASE 3 TENAYA AND LUCERNE TRIALS

Introdução / Purpose

Dual inhibition of Ang-2 and VEG F-A with faricimab, the first bispecific antibody designed for IO use, may promote vascular stability, resulting in increased durability and improved long-term outcomes beyond anti-VEGF treatment alone for nAMD.

Material e Método / Methods

Treat.naïve pts were randomised 1:1 to receive faricimab 6.0 mg up to Q16W after 4 Q4W doses or aflibercept 2.0 mg Q8W after 3 Q4W doses. Pts with faricimab were assessed for protocol-defined disease activity at weeks 20 and 24. Pts with no evidence of active disease at weeks 20 and 24 received Q16W dosing through week 60; those with active disease at week 20 received Q8W dosing; pts with active disease only at week 24 received Q12W dosing.

Resultados / Results

1329 patients with nAMD were enrolled. Baseline characteristics were well balanced. Both trials met their primary endpoint of non-inferiority in mean change in BCVA from baseline averaged over weeks 40, 44 and 48 with fari up to Q16W (+5.8 and +6.6 ETDRS letters in TENAYA (T) and LUCERNE (L), respectively) vs aflibercept Q8W (+5.1 and +6.6 ETDRS letters). Notably, 79.7% (T) and 77.8% (L) of pts in the faricimab up to Q16W arm were on ≥ Q12W dosing intervals at week 48, with 45.7% and 44.9% of pts in T and L, respectively, on a Q16W dosing interval. Reductions in CST from baseline averaged over weeks 40, 44 and 48 with fari up to Q16W (−136.8 and −137.1 µm in T and L, respectively) were comparable with aflibercept Q8W (−129.4 and −130.8 µm). Faricimab was well tolerated; IO inflammation were low and no cases of vasculitis or occlusive retinitis were reported.

Discussão e Conclusões / Conclusion

Faricimab administered at up to Q16W demonstrated non-inferior vision gains vs aflibercept Q8W in pts with nAMD, with ~80% of pts on dosing intervals of ≥ Q12W and ~45% on Q16W fixed dosing intervals at week 48. Faricimab treat. also resulted in meaningful reductions in CST, and was well tolerated.

Palavras Chave

Faricimab
Macular Degeneration
Wet Macular Degeneration
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