EMA application filed by Bayer to expand aflibercept 8 mg indication to include retinal vein occlusion

Bayer announced the submission of an application to the European Medicines Agency (EMA) seeking to expand the indication for aflibercept 8 mg. This dosage of aflibercept (Eylea) will be assessed for treatment of macular edema following retinal vein occlusion (RVO). Central, branch, and hemiretinal RVO are included in this application, Bayer said in a press release. Aflibercept 8 mg is currently approved for the treatment of patients with neovascular age-related macular degeneration (nAMD) and diabetic macular edema (DME).¹

The submission is based on positive results from the phase 3 QUASAR study. In December 2024, Regeneron Pharmaceuticals announced that the trial had met its primary end point.² Aflibercept is being jointly developed by Bayer and Regeneron.

The QUASAR trial compared aflibercept 2 mg with aflibercept 8 mg in patients with RVO, and the primary end point was mean change in best corrected visual acuity (BCVA) through week 36. Patients receiving aflibercept 8 mg were treated with an 8-week dosing regimen, following 3 or 5 initial monthly doses; patients receiving aflibercept 2 mg were treated every 4 weeks.²

Previous reporting from the QUASAR trial³ indicated aflibercept 8 mg results were consistent across patients with branch RVOs, and those patients with central retinal or hemiretinal vein occlusions. Of the patients treated with aflibercept 8 mg through 36 weeks, 88% were able to sustain an 8-week dosing regimen following 3 initial monthly doses, and 93% of patients maintained an 8-week dosing regimen after completing 5 initial monthly doses.

Additionally, according to the press release from Bayer,¹ nearly 70% of those patients had a last assigned dosing interval of 12 weeks. Fluid reduction was similar between the patient groups that received aflibercept 8 mg and aflibercept 2 mg. Finally, Bayer reported, aflibercept 8 mg was well tolerated, and its safety profile was consistent with that of previous trials.

Christine Roth, executive vice president of global product strategy and commercialization and member of the pharmaceuticals leadership team at Bayer, commented on the submission.¹ “Today’s submission is an important step toward improving patient care in retinal vein occlusion,” she said. “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.”

In the United States, Regeneron maintains exclusive rights to aflibercept 2 mg (Eylea 2 mg) and aflibercept 8 mg (Eylea HD); outside the US, Bayer has licensed exclusive marketing rights. According to prior statements² by Regeneron, the companies are also seeking approval from the US Food and Drug Administration for the third indication of aflibercept 8 mg.

References

1. Bayer files for approval of aflibercept 8 mg for treatment of retinal vein occlusion in EU. Press release. Bayer. April 8, 2025. Accessed April 9, 2025. https://firstwordpharma.com/story/5948151

2. Harp MD. Regeneron announces aflibercept 8 mg injection meets primary end point in phase 3 QUASAR trial in patients with retinal vein occlusion. Ophthalmology Times. December 17, 2024. Accessed April 9, 2025. https://www.ophthalmologytimes.com/view/regeneron-announces-aflibercept-8mg-injection-meets-primary-endpoint-in-phase-3-quasar-trial-in-patients-with-retinal-vein-occlusion

3. Harp MD. Regeneron reveals positive results from multiple trials evaluating Eylea HD (aflibercept) injection 8 mg. Ophthalmology Times. February 10, 2025. Accessed April 9, 2025. https://www.ophthalmologytimes.com/view/regeneron-reveals-positive-results-from-multiple-trials-evaluating-eylea-hd-aflibercept-injection-8-mg