Bayer Submits EMA Application to Expand Aflibercept 8mg Indication to Include Retinal Vein Occlusion

Bayer has submitted an application to the European Medicines Agency (EMA) to expand the therapeutic indication for aflibercept 8mg (Eylea HD) to include the treatment of macular edema following retinal vein occlusion (RVO). The application encompasses central retinal vein occlusion (CRVO), branch retinal vein occlusion (BRVO), and hemiretinal vein occlusion (HRVO).

Currently, aflibercept 8mg is approved in the EU for the treatment of neovascular age-related macular degeneration (nAMD) and diabetic macular edema (DME).

Submission Based on Phase 3 QUASAR Trial Data

The EMA application is supported by positive Phase 3 data from the QUASAR trial, announced in December 2024 by Regeneron Pharmaceuticals. The trial met its primary endpoint, demonstrating the efficacy of aflibercept 8mg in patients with RVO.

The QUASAR study compared aflibercept 8mg with aflibercept 2mg in patients with RVO, measuring the mean change in best corrected visual acuity (BCVA) through week 36. Patients in the 8mg group followed an 8-week dosing schedule after receiving three or five initial monthly doses, while those in the 2mg group received treatment every 4 weeks.

Sustained Dosing and Efficacy Across RVO Subtypes

According to the trial data, aflibercept 8mg demonstrated consistent results across all RVO subtypes, including BRVO, CRVO, and HRVO. Notably:

       • 88% of patients maintained an 8-week dosing schedule after 3 initial monthly doses

       • 93% maintained the 8-week interval after 5 initial monthly doses

       • Nearly 70% of patients achieved a final dosing interval of 12 weeks

       • Fluid reduction was similar between the 8mg and 2mg groups

Bayer also reported that aflibercept 8mg was well tolerated, with a safety profile consistent with previous studies.

Bayer’s Statement on the EMA Filing

Christine Roth, Executive Vice President of Global Product Strategy and Commercialization at Bayer, commented on the regulatory milestone:

“Today’s submission is an important step towards improving patient care in retinal vein occlusion. 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.”

Aflibercept Development and Global Commercial Rights

Aflibercept is being jointly developed by Bayer and Regeneron. In the United States, Regeneron retains exclusive rights to both aflibercept 2mg (Eylea 2mg) and aflibercept 8mg (Eylea HD). Bayer holds exclusive marketing rights outside the U.S.

Both companies have also confirmed their intent to seek FDA approval for aflibercept 8mg in RVO as a third indication, following its use in nAMD and DME.