Título / Title

EFFICACY, DURABILITY, AND SAFETY OF FARICIMAB IN DIABETIC MACULAR EDEMA (DME): 2-YEAR RESULTS FROM THE PHASE 3 YOSEMITE AND RHINE TRIALS

Introdução / Purpose

Year 1 data from the phase 3 YOSEMITE/RHINE (Y/R) trials support the hypothesis that dual angiopoietin-2/VEGF-A pathway inhibition with faricimab, the first bispecific antibody designed for intraocular use, may promote vascular stability and durable efficacy beyond current anti-VEGF therapies for DME. Year 2 of Y/R will inform the longer-term efficacy, durability, and safety of faricimab in pts with DME.

Material e Método / Methods

Y/R were identical, randomized, double-masked, active comparator–controlled, 100-week, phase 3 trials of faricimab in treat.-naïve and previously anti-VEGF–treated pts with DME (Y, N = 940; R, N = 951). Pts were randomized 1:1:1 to faricimab 6.0 mg Q8W after 6 initial Q4W doses; faricimab 6.0 mg per personalized treatment interval (PTI) after 4 initial Q4W doses; or aflibercept 2.0 mg Q8W after 5 initial Q4W doses. The PTI algorithm was a protocol-driven T&E regimen, with dosing intervals extended, maintained, or reduced (from Q4W up to Q16W) based on CST and BCVA change at active dosing visits. The primary efficacy endpoint was mean BCVA change from baseline at 1 year. Key 2-year outcomes included mean BCVA change from baseline averaged over weeks 92, 96, and 100; proportion of the faricimab PTI arm on Q4W, Q8W, Q12W, or Q16W dosing at week 96; mean CST change from baseline over 2 years; proportion of patients with ≥ 2-step DRSS improvement from baseline at week 96; and the incidence and severity of adverse events

Resultados / Results

Year 2 results from the Y/R trials will be presented at Angiogenesis 2022

Discussão e Conclusões / Conclusion

Following positive 1-year results, Y/R will examine whether early vision gains, anatomic improvements, and extended (up to Q16W) dosing with faricimab are maintained over 2 years

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