The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended marketing authorization for aflibercept 8 mg (Eylea 8 mg) to treat visual impairment caused by macular edema following retinal vein occlusion, including branch, central and hemiretinal vein occlusion. 

 

A final decision from the European Commission is expected in the coming weeks and would make retinal vein occlusion the third approved indication for Eylea 8 mg in the European Union.

 

“Following the approval of Eylea 8 mg for treatment intervals of up to six months in neovascular age-related macular degeneration and diabetic macular edema in the EU, today's recommendation marks a significant step towards advancing the treatment of retinal vein occlusion. 

 

"Aflibercept 8 mg is set to enhance the standard of care, reducing the burden of frequent injections and clinic visits for patients experiencing macular edema due to retinal vein occlusion, without compromising efficacy and safety,” said Christine Roth, Executive Vice President, Global Product Strategy and Commercialization and Member of the Pharmaceuticals Leadership Team at Bayer.

 

The positive CHMP opinion is supported by results from the Phase III QUASAR trial, which met its primary endpoint at week 36. 

 

The study showed that patients treated with aflibercept 8 mg every two months—after three or five initial monthly injections—achieved non-inferior visual acuity gains and strong fluid control compared with patients receiving monthly Eylea 2 mg. Visual acuity was maintained through week 64, with the higher dose demonstrating what the companies described as unparalleled durability.

 

More than 60% of patients receiving aflibercept 8 mg were able to extend treatment intervals to four months or longer, and 40% reached a final assigned interval of five months. The reduced dosing schedule translated into significantly fewer injections, a key secondary endpoint: patients treated with aflibercept 8 mg received an average of 8.4 injections by week 64, compared with 11.7 injections for those on Eylea 2 mg. 

 

Measures of disease control, including fluid reduction, were comparable between extended-interval aflibercept 8 mg dosing and monthly aflibercept 2 mg, while safety and tolerability were consistent with previous trials.

 

Eylea 8 mg is already approved in more than 60 markets for neovascular age-related macular degeneration and diabetic macular edema. It is currently the first and only anti-VEGF therapy approved in the EU and UK for treatment intervals of up to six months in both indications.

 

Aflibercept 8 mg—marketed as Eylea HD in the United States—is jointly developed by Bayer and Regeneron. Regeneron holds exclusive U.S. rights to Eylea 2 mg and Eylea HD, while Bayer has exclusive marketing rights outside the United States, with the companies sharing profits equally outside the U.S.

 

The QUASAR trial enrolled more than 800 treatment-naïve patients across 27 countries, evaluating extended dosing of aflibercept 8 mg in macular edema secondary to retinal vein occlusion. Patients were treated through week 60 and followed through week 64, providing the data underpinning the CHMP’s recommendation.