Bayer seeks EMA approval for Aflibercept for retinal vein occlusion treatment
Berlin: Bayer has submitted an application to the European Medicines Agency (EMA) seeking approval of aflibercept 8 mg (114.3 mg/ml solution for injection) for the treatment of patients with macular edema following retinal vein occlusion (RVO) including central, branch and hemiretinal vein occlusion. This would be the third indication for aflibercept 8 mg supporting the blockbuster status of Eylea.
The submission is based on positive results from the global randomized, double-masked, active-controlled phase III QUASAR study. The study met its primary end point at week 36, demonstrating that patients receiving aflibercept 8 mg every 8 weeks (after initial monthly doses) achieved non-inferior visual acuity gains compared to those receiving the current standard therapy, Eylea 2 mg (aflibercept 2 mg) every 4 weeks.
“The submission is an important step towards improving patient care in retinal vein occlusion,” said Christine Roth, Executive Vice President, Global Product Strategy and Commercialization, and Member of the Pharmaceuticals Leadership Team at Bayer. “Once approved, aflibercept 8 mg expands durable treatment options alleviating the burden of frequent injections and clinic visits for patients living with retinal vein occlusion.”
The QUASAR clinical study demonstrated that approximately 90% of patients on aflibercept 8 mg maintained their extended 8-week dosing intervals through 36 weeks, and almost 70% had a last assigned dosing interval of 12 weeks. Importantly, fluid reduction – an indicator of disease control – was similar with extended dosing intervals of aflibercept 8 mg compared with monthly doses of Eylea 2 mg. Additionally, aflibercept 8 mg was well tolerated, and its safety profile was consistent with previous clinical trials.
Eylea 8 mg has been approved to date in more than 50 markets for the treatment of nAMD and DME. Further regulatory applications for Eylea 8 mg in additional markets are ongoing.
Eylea 8 mg is an anti-vascular endothelial growth factor-treatment (anti-VEGF) that is approved for extended treatment intervals of up to 5 months for both, neovascular (wet) age-related macular degeneration (nAMD) and diabetic macular edema (DME), in the EU and UK.
In February 2025, Bayer submitted an application to EMA to expand treatment intervals to up to 6 months with Eylea 8 mg for the treatment of nAMD and DME based on clinical evidence from the PULSAR and PHOTON studies.
Eylea 8 mg (aflibercept 8 mg; in the United States: Eylea HD) is being jointly developed by Bayer and Regeneron. Regeneron maintains exclusive rights to Eylea 2 mg (aflibercept 2 mg) and Eylea HD in the United States. Bayer has licensed the exclusive marketing rights outside the United States, where the companies share equally the profits from sales of Eylea 2 mg and Eylea 8 mg.
