The European Commission has granted marketing authorisation across the European Union for Bayer AG's Eylea 8 mg (aflibercept 8 mg) for the treatment of visual impairment caused by macular edema following retinal vein occlusion (RVO), including branch, central, and hemiretinal vein occlusion. This approval marks RVO as the third approved indication for Eylea 8 mg in the EU, expanding its retinal disease portfolio.
The approval is supported by data from the Phase III QUASAR clinical trial, which demonstrated that Eylea 8 mg delivers non-inferior visual and anatomical outcomes compared with Eylea 2 mg, while significantly reducing treatment burden. In the early phase of RVO management, patients typically require monthly intravitreal injections. In QUASAR, patients receiving Eylea 8 mg required substantially fewer monthly dosing intervals despite having the option to extend treatment schedules across all study arms.
Following three initial monthly doses, patients treated with Eylea 8 mg maintained visual acuity while receiving an average of 2–3 fewer injections over 64 weeks compared with those treated with Eylea 2 mg. Fluid reduction, a key marker of disease control, remained comparable between extended dosing with aflibercept 8 mg and more frequent dosing with aflibercept 2 mg. The study also confirmed a favourable safety and tolerability profile consistent with prior clinical trials.
The QUASAR study met its primary endpoint at week 36, showing that dosing Eylea 8 mg every two months after initial loading doses achieved non-inferior visual acuity gains and robust fluid control versus monthly Eylea 2 mg. Extended follow-up data through week 64 demonstrated sustained visual outcomes and enhanced durability, with more than 60% of patients able to achieve treatment intervals of four months or longer, and 40% extending to five months.
With this approval, Eylea 8 mg is now authorised in the EU for the treatment of wet age-related macular degeneration, diabetic macular edema, and retinal vein occlusion. It is currently the only anti-VEGF therapy approved in the EU and UK that allows extended dosing intervals of up to six months for both nAMD and DME.
Eylea 8 mg has already received approval in more than 60 global markets for nAMD and DME. In the United States, the therapy is marketed as Eylea HD. The product is jointly developed by Bayer and Regeneron, with Regeneron holding exclusive US rights, while Bayer retains exclusive marketing rights outside the US and shares profits equally with Regeneron.
Retinal vein occlusion is a chronic vascular disorder affecting an estimated 28 million adults worldwide and is a leading cause of sudden vision loss. It occurs when retinal veins become blocked, leading to reduced oxygen delivery, increased VEGF production, and subsequent fluid leakage into the macula. This process results in macular edema, which significantly impairs central vision.
Bayer continues to strengthen its ophthalmology portfolio through expanded indications for Eylea 8 mg, reinforcing its focus on durable therapies that reduce treatment burden while maintaining long-term visual outcomes for patients with retinal diseases.
