Bayer Submits EU Application for Aflibercept 8 mg to Treat Retinal Vein Occlusion
Bayer Submits EU AG has officially submitted an application to the European Medicines Agency (EMA) seeking approval for 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 retinal vein occlusion (CRVO), branch retinal vein occlusion (BRVO), and hemiretinal vein occlusion (HRVO). This submission represents a significant advancement in expanding the therapeutic indications of aflibercept 8 mg, further solidifying the status of Eylea™ as a leading treatment in ophthalmology.
Bayer Submits EU The application is grounded in the robust findings from the global Phase III QUASAR trial, a randomized, double-masked, active-controlled study that evaluated the efficacy and safety of aflibercept 8 mg in patients with macular edema secondary to RVO. The QUASAR study successfully met its primary endpoint at week 36, demonstrating that patients receiving aflibercept 8 mg every eight weeks (following initial monthly doses) achieved non-inferior visual acuity gains compared to those receiving the current standard therapy, Eylea 2 mg administered every four weeks.
Bayer Submits EU Christine Roth, Executive Vice President of Global Product Strategy and Commercialization and Member of the Pharmaceuticals Leadership Team at Bayer, emphasized the importance of this development:
“Bayer Submits EU 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.”
Detailed Findings from the QUASAR Study
The QUASAR trial provided compelling evidence supporting the efficacy and safety of aflibercept 8 mg in the treatment of macular edema following RVO. Key findings include:Bayer – Global Home
- Extended Dosing Intervals: Approximately 90% of patients treated with aflibercept 8 mg were able to maintain an eight-week dosing interval through week 36. Notably, nearly 70% of these patients were assigned a 12-week dosing interval by week 32, indicating the potential for even longer intervals between treatments. Bayer – Global Home
- Visual Acuity Gains: Patients receiving aflibercept 8 mg every eight weeks achieved visual acuity improvements that were non-inferior to those observed in patients receiving Eylea 2 mg every four weeks, the current standard of care.
- Fluid Reduction: The reduction in retinal fluid, as measured by changes in central subfield thickness (CST), was comparable between the aflibercept 8 mg extended dosing groups and the Eylea 2 mg monthly dosing group. This suggests effective disease control with fewer injections. Bayer – Global Home+1Pipelinereview+1
- Safety Profile: Aflibercept 8 mg was well tolerated, with a safety profile consistent with previous clinical trials. The incidence of ocular treatment-emergent adverse events was low, and there were no new safety signals identified. HCPLive+1BioSpace+1
Implications for Patient Care
Bayer Submits EU The potential approval of aflibercept 8 mg for RVO could significantly impact patient care by reducing the treatment burden associated with frequent intravitreal injections. Current therapies often require monthly injections, which can be challenging for patients and healthcare systems. The extended dosing intervals demonstrated with aflibercept 8 mg offer the possibility of maintaining visual acuity gains with fewer clinic visits, thereby improving patient adherence and overall quality of life.
Professor Richard Gale, Clinical Director at York Teaching Hospital in the UK, highlighted the significance of these findings:Bayer – Global Home
“Bayer Submits EU These encouraging data demonstrate that aflibercept 8 mg has the potential to become a new standard of care in the treatment of exudative retinal diseases, including patients living with retinal vein occlusion, which is known to have a high VEGF load.” Bayer – Global Home
Regulatory Status and Future Directions
Bayer Submits EU Aflibercept 8 mg, marketed as Eylea™ 8 mg, has already received approval in over 50 countries for the treatment of neovascular (wet) age-related macular degeneration (nAMD) and diabetic macular edema (DME). In the European Union and the United Kingdom, it is the only anti-vascular endothelial growth factor (anti-VEGF) treatment approved for extended dosing intervals of up to five months for both nAMD and DME. In February 2025, Bayer submitted an application to the EMA to further extend treatment intervals to up to six months based on clinical evidence from the PULSAR and PHOTON studies.
Bayer Submits EU The current submission to the EMA for the indication of macular edema following RVO represents another step in expanding the therapeutic applications of aflibercept 8 mg. Regulatory applications in additional markets are ongoing, reflecting Bayer’s commitment to making this treatment accessible to a broader patient population.
Collaboration and Development
Bayer Submits EU Aflibercept 8 mg is being jointly developed by Bayer and Regeneron Pharmaceuticals, Inc. Under this collaboration, Regeneron maintains exclusive rights to Eylea 2 mg and Eylea HD (aflibercept 8 mg) in the United States, while Bayer holds exclusive marketing rights outside the United States. The companies share equally in the profits from sales of Eylea 2 mg and Eylea 8 mg in their respective territories. Bayer – Global Home
Understanding Retinal Vein Occlusion
Retinal vein occlusion (RVO) is a significant cause of vision loss worldwide, affecting approximately 28 million adults. It occurs when a blockage in the retinal veins leads to increased pressure, hemorrhage, and fluid leakage in the retina, resulting in macular edema.
