VABYSMO (faricimab) - Neovascular (wet) retrofoveal age-related macular degeneration (AMD)

The clinical benefit of VABYSMO (faricimab) 120 mg/mL solution for injection is substantial in the treatment of neovascular (wet) retrofoveal age-related macular degeneration (AMD) in adults.

Considering:

• evidence of the non-inferiority of VABYSMO (faricimab, using a QW8/QW12/QW16 personalised administration regimen) compared to EYLEA (aflibercept, using a Q8W fixed administration regimen), based on the functional endpoint of visual acuity, in two randomised, double-blind, phase 3 trials in adults with neovascular (wet) age-related macular degeneration (AMD) and who are treatment-naïve;
• the absence of a comparison between faricimab administered using a personalised regimen and aflibercept administered using a “Treat-and-Extend” regimen;
• the lack of robust evidence of an additional impact on quality life or on the patient’s care and life pathway (particularly in terms of a reduction in the frequency of injections) compared to the available alternatives;
• safety comparable to that recorded for aflibercept;

the Committee deems that VABYSMO (faricimab) solution for injection provides no clinical added value (CAV V) compared to EYLEA (aflibercept) solution for injection in pre-filled syringe in the treatment of neovascular (wet) retrofoveal age-related macular degeneration (AMD) in adults.