Faricimab (3) – Vabysmo®

• Clinical trials
  • The pharmaceutical manufacturer identifies the two randomised controlled trials (RCTs), BALATON and COMINO, within the indicated therapeutic indication.
  • Both studies are double-blind, multicentre RCTs comparing faricimab with aflibercept.
  • The BALATON study included adult patients with visual impairment due to macular oedema resulting from a branch retinal vein occlusion (BRVO), whilst the COMINO study included patients with visual impairment due to a central retinal vein occlusion (CRVO) or a hemiretinal vein occlusion.

a) Adults with visual impairment due to macular oedema resulting from a branch vein occlusion (BVO)

• The additional benefit of faricimab compared with the appropriate comparator therapy is not proven.
• No evaluable data are available for assessing the additional benefit of faricimab compared with the appropriate comparator therapy.
• Overall assessment
  • For this patient group, the pharmaceutical manufacturer presents the BALATON RCT, in which faricimab is compared with aflibercept.
  • As part of the BALATON study, all patients in both arms received six monthly intravitreal injections.
  • No flexibility in the treatment regimen was provided for during the comparative phase of the study.
  • Based on the data on best-corrected visual acuity and central visual field thickness, it can be seen that the disease stabilised in a significant proportion of patients as early as 8 to 12 weeks.
  • As the flexibility in the treatment regimen – which, according to the SmPC for both faricimab and aflibercept, would have been indicated for a significant proportion of patients – what was not planned, the BALATON study is not taken into account for the present benefit assessment, in accordance with the pharmaceutical manufacturer’s approach as set out in the dossier.

b) Adults with visual impairment due to macular oedema resulting from central retinal vein occlusion (CRVO)

• The additional benefit of faricimab compared with the appropriate comparator therapy is not proven.
• No evaluable data are available for assessing the additional benefit of faricimab compared with the appropriate comparator therapy.
• Overall assessment
  • For this patient group, the pharmaceutical manufacturer presents the COMINO RCT, in which faricimab is compared with aflibercept.
  • As part of the COMINO study, all patients in both arms received six monthly intravitreal injections.
  • No flexibility in the treatment regimen was provided for during the comparative phase of the study.
  • The data on best-corrected visual acuity and central visual field thickness show that, in a significant proportion of patients, the disease stabilised as early as 8 to 12 weeks.
  • As the flexibility in the treatment regimen—which, according to the SmPC for both faricimab and aflibercept, would have been indicated for a significant proportion of patients— what was not planned, the COMINO study is not taken into account for the present benefit assessment, in accordance with the pharmaceutical manufacturer’s approach as set out in the dossier.

Courtesy translation only, please refer to the German original.