EC’s High-Dose Aflibercept Approval Highlights Durable Anti-VEGF Retinal Therapy

The European Commission’s (EC’s) marketing authorization approval for aflibercept 8 mg (Eylea 8 mg) extends the therapy’s use to patients in the European Union (EU) with visual impairment due to macular edema following retinal vein occlusion (RVO), including branch, central, and hemiretinal vein occlusion. This decision establishes RVO as the third approved retinal indication for the higher-dose formulation of aflibercept and reflects continued regulatory interest in therapies that combine efficacy with extended durability (1).

The EC’s approval follows an earlier regulatory decision in the United States in which FDA granted priority review status to the 8 mg aflibercept (Eylea HD) format for the same indication (2). Aflibercept, a recombinant fusion protein and anti-vascular endothelial growth factor (anti-VEGF) therapy, is being jointly developed by Bayer and Regeneron Pharmaceuticals (1).

RVO is a chronic vascular disorder of the retina that can lead to sudden and severe vision loss. Globally, it affects an estimated 28 million adults and is associated with elevated levels of vascular endothelial growth factor and placental growth factor, which drive vascular leakage and macular edema (3). Anti-VEGF therapies have become the standard of care, but treatment burden remains a persistent challenge due to the need for frequent intravitreal injections, particularly during early disease management (4).

How does extended dosing matter for retinal disease management?

In routine clinical practice, patients with RVO often require monthly injections during the initial treatment phase. This intensity can strain healthcare systems and reduce adherence, especially among older patients who may still be active in the workforce. The approval of aflibercept 8 mg is anchored in data from the Phase III QUASAR clinical trial, which evaluated whether a higher dose could sustain disease control with fewer injections (1).

“Retinal vein occlusion often presents with sudden vision loss and affects older people who are still of working age,” said trial investigator Richard Gale, professor of Ophthalmology, Hull York Medical School (HYMS), University of York, and consultant medical ophthalmologist, in a company press release (1). “Early diagnosis and treatment are essential to help prevent irreversible vision loss; however, the treatment burden of frequent injections can be challenging for patients. In the Phase III clinical trial QUASAR, Eylea 8 mg demonstrated in the key secondary endpoint that it can meaningfully reduce the number of injections while maintaining visual acuity and providing a favorable safety profile”.

According to the trial results, by week 64, patients receiving aflibercept 8 mg required an average of two to three fewer injections than those receiving aflibercept 2 mg, while maintaining comparable visual acuity outcomes. More than 60% of patients achieved a final dosing interval of four months or longer, and 40% reached five-month intervals, suggesting that higher-dose strategies may help rebalance efficacy and durability in chronic retinal care (1).

What did the Phase III trial reveal about efficacy and safety?

Bayer reported that the Phase III (QUASAR) study met its primary endpoint at week 36, demonstrating non-inferior visual acuity gains and robust fluid control for aflibercept 8 mg administered every two months after initial monthly dosing, compared with monthly aflibercept 2 mg (1). Importantly, anatomic outcomes, including retinal fluid reduction, were similar despite extended dosing intervals. Safety findings were consistent with previous trials, reinforcing confidence in the higher-dose formulation.

From an industry perspective, these data contribute to a growing body of evidence supporting dose optimization as a pathway to reducing treatment burden without compromising outcomes. This has implications not only for patient care but also for manufacturing scale-up, lifecycle management, and long-term health economics (5).

Why is this approval relevant for the broader biopharmaceutical industry?

The EC’s authorization further expands the range of retinal diseases addressed by aflibercept 8 mg in the EU, alongside wet age-related macular degeneration and diabetic macular edema.

“Eylea 8 mg represents a new treatment option for patients with macular edema due to retinal vein occlusion, addressing the demand for more durable therapies,” said Christine Roth, executive vice-president, Global Product Strategy and Commercialization, and member of the Pharmaceuticals Leadership Team, Bayer, in the release (1). “The recent approval in the European Union expands the range of retinal indications for Eylea 8 mg—now encompassing wet age-related macular degeneration, diabetic macular edema, and retinal vein occlusion.”

More broadly, the decision highlights how regulators are responding to clinical strategies that prioritize durability and reduced intervention frequency. For biopharmaceutical developers and manufacturers, this trend underscores the importance of formulation science, dose-ranging studies, and scalable production processes capable of supporting next-generation biologics designed for extended treatment intervals (6).

References

1. Bayer. Eylea 8 mg Approved in the EU for Third Retinal Indication. Press Release. Jan. 16, 2026.
2. Regeneron Pharmaceuticals. EYLEA HD (aflibercept) Injection 8 mg sBLA Accepted for FDA Priority Review for Both the Treatment of Macular Edema Following Retinal Vein Occlusion (RVO) and for Monthly Dosing in Approved Indications. Press Release. April 17, 2025.
3. Jiang, B.; Wei, X.; Cao, X.; Zheng, C. Insights into Modifiable Risk Factors of Retinal Vascular Occlusion: A Mendelian Randomization Study. Medicine (Baltimore) 2025, 104 (18), e41752. DOI: 10.1097/MD.0000000000041752
4. Galvez-Olortegui, J.; Bouchikh-El Jarroudi, R.; Silva-Ocas, I.; et al. Systematic Review of Clinical Practice Guidelines for the Diagnosis and Management of Retinal Vein Occlusion. Eye (Lond). 2024, 38 (9), 1722–1733. DOI: 10.1038/s41433-024-03008-1
5. Khanna, S.; Komati, R.; Eichenbaum, D. A.; et al. Current and Upcoming Anti-VEGF Therapies and Dosing Strategies for the Treatment of Neovascular AMD: A Comparative Review. BMJ Open Ophthalmology 2019, 4, e000398. DOI: 10.1136/bmjophth-2019-000398
6. Luckham, K.; Tebbs, H.; Dadswell, C.; et al. Cost-Effectiveness of Anti-Vascular Endothelial Growth Factor and Macular Laser Treatments for People with Center-Involving Diabetic Macular Edema and Central Retinal Thickness of at Least 400 Micrometers. Eye 2025, 39, 2963–2972. DOI: 10.1038/s41433-025-04015-6