Faricimab (1) – Vabysmo®

• Clinical trials
  • The RHINE and YOSEMITE trials are randomised, double-blind Phase III trials comparing faricimab with aflibercept.

Adults with visual impairment due to diabetic macular oedema (DME)

• For adults with visual impairment due to DME, the additional benefit of faricimab over aflibercept is not proven.
• mortality
  • For the endpoint of all-cause mortality, the RHINE study shows a statistically significant difference in favour of faricimab.
  • In the YOSEMITE study, as well as in the meta-analysis of both studies, no statistically significant difference was observed between the treatment groups.
• Morbidity – Best Corrected Visual Acuity (BCVA) – improvement of ≥ 10 and ≥ 15 ETDRS letters
  • For the BCVA endpoint (improvement of ≥ 10 and ≥ 15 ETDRS letters), no statistically significant difference between the treatment groups was observed either at the individual study level or in the meta-analysis of the RHINE and YOSEMITE studies.
• Morbidity – NEI VFQ-25 (Health Status subscale)
  • For the health status endpoint (assessed using the NEI VFQ-25, General Health subscale), no statistically significant difference between the treatment groups was observed either at the individual study level or in the meta-analysis of the two studies, RHINE and YOSEMITE.
• Quality of life – National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25) – total score
  • For the endpoint of health-related quality of life (assessed using the total score of the NEI VFQ-25), no statistically significant difference between the treatment groups was observed in the meta-analysis of the RHINE and YOSEMITE studies, nor in either of the individual studies.
• Side effects – SAE, discontinuation due to AE, ocular AE and ocular SAE
  • For the endpoints SAE, discontinuation due to AEs, ocular AEs and ocular SAE, the meta-analysis of the RHINE and YOSEMITE studies, as well as both individual studies, showed no statistically significant difference between the treatment groups.
• Overall assessment / Conclusion
  • In summary, there was no statistically significant difference in mortality between the treatment groups.
  • In the morbidity category, no statistically significant difference between faricimab and aflibercept was observed in terms of changes in best-corrected visual acuity or health status.
  • In the quality of life category, there is no statistically significant difference between faricimab and the appropriate comparator therapy, aflibercept, in terms of vision-related quality of life as assessed using the NEI VFQ-25.
  • In the category of side effects, no advantages or disadvantages relevant to the benefit assessment can be identified for faricimab compared with aflibercept overall.
  • Overall, based on the studies submitted for year 1, there are neither advantages nor disadvantages for faricimab compared with the appropriate comparator therapy, aflibercept, in the treatment of visual impairment resulting from DMÖ.
  • An additional benefit for faricimab compared with the appropriate comparator therapy, aflibercept, is therefore not proven for adults with visual impairment resulting from DMÖ.

Courtesy translation only, please refer to the German original.