Aflibercept (2) – Eylea®

• Clinical trials
  • The COPERNICUS and GALILEO trials, on which the marketing authorisation for aflibercept is based, were designed to demonstrate the efficacy, safety and tolerability of repeated intravitreal administration of the active ingredient (INN) in patients with impaired visual acuity due to macular oedema resulting from central retinal vein occlusion (CRVO). These were randomised, double-blind (at least during the first treatment phase) controlled trials comparing intravitreal injection (IVT) of 2 mg of aflibercept with a sham injection in a 3:2 ratio, stratified by geographical region and baseline BCVA.
  • The CRUISE study, which the pharmaceutical manufacturer has included in its study pool as the data basis for the appropriate comparator therapy, ranibizumab, also features a randomised, controlled parallel-group design with double-blinding up to week 24.

Patients with chronic diabetic macular oedema who are suitable for intravitreal therapy

• The additional benefit of aflibercept compared with the appropriate comparator therapy, dexamethasone (intravitreal implant) or ranibizumab is not proven.
• In light of these considerations, based on the information in the dossier, the results of the benefit assessment and the expert opinions, the G-BA finds no proof of additional benefit from aflibercept compared with the appropriate comparator therapy, dexamethasone (intravitreal implant) or ranibizumab.
• The additional benefit of aflibercept compared with the appropriate comparator therapy, dexamethasone (intravitreal implant) or ranibizumab is not proven.
• Conclusion
  • Based on these considerations, the information contained in the dossier, the results of the benefit assessment and the expert opinions, the G-BA finds no proof of additional benefit from aflibercept compared with the appropriate comparator therapy, dexamethasone (intravitreal implant) or ranibizumab.
  • In the G-BA’s view, there is a lack of a clear evidence base for assessing the additional benefit of aflibercept. The documents submitted with the dossier are therefore insufficient to provide proof of additional benefit compared with the appropriate comparator therapy.

Courtesy translation only, please refer to the German original.