The European Commission has granted marketing authorization for Eylea 8 mg (aflibercept 8 mg) in the European Union. The approval covers macular edema following retinal vein occlusion (RVO), including branch, central, and hemiretinal vein occlusion.
This marks the third approved indication for Eylea 8 mg in Europe.
Retinal vein occlusion often causes sudden vision loss. It typically affects older adults who are still working. Early treatment is critical. But frequent injections increase treatment burden and reduce adherence.
Eylea 8 mg is designed to address this gap by offering longer dosing intervals without compromising outcomes.
The approval is based on data from the QUASAR clinical trial. Core findings include:
By week 64:
Safety outcomes were consistent with prior Eylea studies
Eylea 8 mg demonstrated unmatched durability. By the end of the study:
This reduces clinic visits while maintaining visual outcomes.
With this decision, Eylea 8 mg is now approved in the EU for:
It remains the only anti-VEGF therapy approved in the EU and UK for dosing intervals of up to six months in both nAMD and DME.
RVO affects 28 million adults worldwide. It remains a chronic condition with a high treatment burden.
The EU approval of Eylea 8 mg signals a shift toward durable retinal therapies that reduce injection frequency while preserving vision.