Aflibercept (5) – Eylea®

• Clinical trials
  • The MYRROR registration trial for aflibercept (for the treatment of visual impairment due to myopic CNV) was a randomised, placebo-controlled, double-blind Phase III clinical trial.
  • The target population for the trial was adult patients (aged ≥18 years) with choroidal neovascularisation (CNV) due to pathological myopia (PM). At the start of the trial, the treatment arm received a single intravitreal injection of aflibercept, followed by monthly follow-up injections as required, whilst the control arm received intravitreal sham injections.

Adults for the treatment of visual impairment due to myopic choroidal neovascularisation (myopic CNV)

• For patients with visual impairment due to myopic choroidal neovascularisation (myopic CNV), additional benefit is not proven.
• The pharmaceutical manufacturer has not submitted any study to assess the additional benefit of aflibercept compared with the G-BA’s appropriate comparator therapy (ranibizumab).
• This is because the G-BA’s appropriate comparator therapy was not used in any study.
• Furthermore, the pharmaceutical manufacturer has not identified any study for a possible indirect comparison.
• The G-BA cannot take the MYRROR study into account because ‘sham injections’ do not constitute the appropriate comparator therapy.
• On the basis of the information in the dossier, the IQWiG’s benefit assessment and the comments on the benefit assessment, the G-BA concludes that the additional benefit of aflibercept over the appropriate comparator therapy is not proven.
• Morbidity – improvement in visual acuity with best possible correction
  • The primary endpoint examined was the improvement in best-corrected visual acuity over a period of 24 weeks.
• Conclusion
  • On the basis of the information in the dossier, the IQWiG’s benefit assessment and the comments on the benefit assessment, the G-BA concludes that additional benefit from aflibercept compared with the appropriate comparator therapy is not proven.

Courtesy translation only, please refer to the German original.