The European Commission has approved Eylea 8 mg for use across the European Union to treat vision loss caused by macular edema following retinal vein occlusion (RVO), a common and potentially blinding vascular eye disease. The decision marks the third approved indication for the higher-dose formulation of aflibercept.

 

RVO, which includes branch, central and hemiretinal vein occlusion, often strikes suddenly and disproportionately affects older adults who remain in the workforce. Treatment typically requires frequent injections directly into the eye—an ongoing burden for patients and health systems alike.

 

“Retinal vein occlusion often presents with sudden vision loss and affects older people who are still of working age. Early diagnosis and treatment are essential to help prevent irreversible vision loss; however, the treatment burden of frequent injections can be challenging for patients. 

 

"In the Phase III clinical trial QUASAR, Eylea 8 mg demonstrated in the key secondary endpoint that it can meaningfully reduce the number of injections while maintaining visual acuity and providing a favorable safety profile,” said Richard Gale, Professor of Ophthalmology at Hull York Medical School, University of York, and a QUASAR trial investigator.

 

Approval is based on results from the Phase III QUASAR study, which showed that Eylea 8 mg matched the visual and anatomical outcomes of standard-dose Eylea 2 mg while significantly reducing the need for monthly injections. 

 

After three initial monthly doses, patients treated with Eylea 8 mg required an average of 2–3 fewer injections by week 64 than those receiving Eylea 2 mg (8.4 versus 11.7), even though all participants were eligible for extended dosing.

 

Importantly, disease control—as measured by retinal fluid reduction—was comparable between Eylea 8 mg given at longer intervals and Eylea 2 mg administered more frequently. The higher-dose therapy was well tolerated, with a safety profile consistent with earlier trials.

 

“Eylea 8 mg represents a new treatment option for patients with macular edema due to retinal vein occlusion, addressing the demand for more durable therapies. 

 

"The recent approval in the European Union expands the range of retinal indications for Eylea 8 mg – now encompassing wet age-related macular degeneration, diabetic macular edema, and retinal vein occlusion,” said Christine Roth, Executive Vice President, Global Product Strategy and Commercialization at Bayer.

 

The QUASAR trial met its primary endpoint at week 36, demonstrating that Eylea 8 mg administered every two months—after three or five initial monthly injections—delivered non-inferior visual acuity gains and strong fluid control compared with monthly Eylea 2 mg. 

 

Longer-term data showed sustained vision outcomes through week 64, with more than 60% of patients able to extend treatment intervals to four months or longer, and 40% reaching five months.

 

Eylea 8 mg has already been approved in more than 60 markets for neovascular (wet) age-related macular degeneration and diabetic macular edema.