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20 Jan 2026
Admin
News Article

EU Approves Eylea 8 mg for Retinal Vein Occlusion

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.

Why This Approval Matters?

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.

Key Results From the QUASAR Phase III Trial

The approval is based on data from the QUASAR clinical trial. Core findings include:

Non-inferior visual acuity compared to Eylea 2 mg
Comparable fluid control, a key marker of disease control
Fewer injections over time

By week 64:

Patients on Eylea 8 mg required 2–3 fewer injections
Average injections: 8.4 vs. 11.7 with Eylea 2 mg
Three times fewer patients needed monthly dosing

Safety outcomes were consistent with prior Eylea studies

Durability Sets Eylea 8 mg Apart

Eylea 8 mg demonstrated unmatched durability. By the end of the study:

Over 60% of patients reached dosing intervals of four months or longer
40% achieved five-month intervals

This reduces clinic visits while maintaining visual outcomes.

Expanded Retinal Indications in Europe

With this decision, Eylea 8 mg is now approved in the EU for:

Wet age-related macular degeneration (nAMD)
Diabetic macular edema (DME)
Macular edema due to retinal vein occlusion (RVO)

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.

Global Status and Commercial Rights

Approved in 60+ markets for nAMD and DME
Developed jointly by Bayer and Regeneron
Regeneron holds US rights for Eylea 2 mg and Eylea HD
Bayer markets Eylea outside the US

The Bigger Picture

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.

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