Bayer files EMA application for aflibercept 8mg in third indication, retinal vein occlusion

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Bayer announced the submission of an application to the European Medicines Agency (EMA) seeking to expand the indication for aflibercept 8mg. 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 8mg 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 met its primary endpoint.² Aflibercept is being jointly developed by Bayer and Regeneron.

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

Previous reporting from the QUASAR trial³ indicated aflibercept 8mg results were consistent across patients with branch retinal vein occlusions, and those patients with central retinal or hemiretinal vein occlusions. Of the patients treated with aflibercept 8mg through 36 weeks, 88% of patients 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 Bayer¹ nearly 70% of those patients had a last assigned dosing interval of 12 weeks. Fluid reduction was similar between the patient groups who received aflibercept 8mg and aflibercept 2mg. Finally, Bayer reported, aflibercept 8mg was well tolerated and its safety profile was consistent with 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 towards 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 2mg (Eylea 2mg) and aflibercept 8mg (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 8mg.

References

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

2. Harp M D. Regeneron announces aflibercept 8mg injection meets primary endpoint in phase 3 QUASAR trial in patients with retinal vein occlusion. Ophthalmology Times. Published 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 M D. Regeneron reveals positive results from multiple trials evaluating Eylea HD (aflibercept) injection 8 mg. Ophthalmology Times. Published February 10, 2025. Accessed April 9, 2025.