Bayer’s Eylea™ 8 mg Recommended for EU Approval with Extended 6-Month Treatment Interval for Major Retinal Diseases
Bayer has today announced a significant milestone in the treatment of retinal diseases, revealing that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending a label extension for Eylea™ 8 mg (aflibercept 8 mg, 114.3 mg/ml solution for injection). This recommendation, pending final approval by the European Commission expected within the coming weeks, would allow patients with two of the most debilitating retinal conditions—neovascular (wet) age-related macular degeneration (nAMD) and diabetic macular edema (DME)—to benefit from an extended dosing interval of up to six months.
If approved, this label extension would position Eylea 8 mg as the only anti-vascular endothelial growth factor (anti-VEGF) therapy authorized in the European Union to offer such prolonged treatment intervals for both nAMD and DME, marking a transformative advancement in patient care.
Extended Treatment Intervals: A New Standard of Care
Christine Roth, Executive Vice President of Global Product Strategy and Commercialization and a member of Bayer’s Pharmaceuticals Leadership Team, emphasized the profound clinical and patient-centric impact of this advancement. “Following approval of the European Commission, extended treatment intervals with Eylea 8 mg of up to six months can significantly reduce the frequency of injections and visits to the clinic for patients,” she said. “These extended intervals, combined with the unique product profile of Eylea 8 mg, position it to become a new standard of care for retinal diseases.”
The importance of this development cannot be overstated. Traditionally, patients with nAMD and DME require frequent injections—often monthly or bi-monthly—which can be burdensome and disrupt quality of life. By enabling longer intervals between treatments, Eylea 8 mg aims to lessen this treatment burden while maintaining therapeutic efficacy, potentially improving adherence and outcomes.
Robust Clinical Evidence Supporting the Extension
The CHMP’s positive opinion is grounded in compelling long-term clinical data derived from two pivotal open-label extension studies, PULSAR and PHOTON, which followed patients for three years after initial participation in the pivotal trials evaluating Eylea 8 mg.
- PULSAR Study: This study focused on patients with neovascular age-related macular degeneration (nAMD). Patients randomized to receive Eylea 8 mg at the start maintained their visual acuity and anatomical improvements through three years of treatment. Notably, by the end of the study, approximately 24% of patients were able to extend their dosing interval to six months without losing clinical benefit.
- PHOTON Study: Targeting diabetic macular edema (DME), this extension study similarly demonstrated durable vision preservation and anatomical stability over three years. Impressively, 28% of patients in the DME cohort achieved the extended six-month dosing interval at the study’s conclusion.
These results underscore the potential for many patients to achieve effective disease control with less frequent intravitreal injections, which is a substantial step forward in treatment convenience and patient quality of life.
Safety Profile Remains Favorable Over Long-Term Use
Alongside efficacy, the long-term safety profile of Eylea 8 mg remained consistent and reassuring throughout the third year of both extension studies. No new safety concerns or adverse signals were detected, even among patients transitioning from the previously approved Eylea 2 mg dose to the higher 8 mg dosage. The rates of ocular treatment-emergent adverse events were comparable across all treatment groups, reinforcing the drug’s established safety profile.
This long-term data provides clinicians and patients with confidence that extending the interval between injections does not compromise safety, a critical consideration when modifying treatment regimens for chronic retinal diseases.
Eylea’s Established Position and Ongoing Development
Eylea 8 mg has already secured regulatory approvals in more than 50 countries worldwide for the treatment of nAMD and DME, reflecting its global recognition as a leading anti-VEGF therapy. Bayer continues to submit regulatory applications in additional markets to expand patient access further.
Currently, Eylea 8 mg holds the unique distinction as the only anti-VEGF treatment in the European Union and the United Kingdom approved for extended treatment intervals of up to five months after an initial three monthly injection loading phase for both nAMD and DME. The potential approval for six-month intervals would extend this leadership further.
Since its initial launch, Eylea has become a global market leader for retinal diseases, with more than 88 million administrations and over 12 million patient-years of clinical experience worldwide, underscoring its role as a cornerstone therapy in ophthalmology.
Collaboration Between Bayer and Regeneron
The development and commercialization of Eylea 8 mg represent a strategic collaboration between Bayer and Regeneron Pharmaceuticals. Regeneron holds exclusive rights to market Eylea 2 mg (aflibercept 2 mg) and Eylea HD in the United States, while Bayer has exclusive marketing rights outside the U.S. Both companies share equally in the profits derived from sales of Eylea 2 mg and Eylea 8 mg globally (excluding the U.S.).
This partnership has facilitated robust clinical development and global reach, allowing more patients across diverse regions to benefit from advancements in retinal disease treatment.
The Clinical and Patient Impact of Eylea 8 mg’s Extended Dosing Interval
Age-related macular degeneration (AMD) and diabetic macular edema (DME) are two of the leading causes of vision loss worldwide. Both conditions involve pathological growth and leakage of blood vessels in the retina, mediated by vascular endothelial growth factor (VEGF). Anti-VEGF agents like Eylea have revolutionized treatment, improving vision outcomes dramatically compared to previous standards of care.
However, the frequent injection schedule—typically monthly or bi-monthly—is a significant hurdle for patients, many of whom are elderly or have comorbidities that complicate regular clinic visits. Frequent injections also pose a risk of injection-related complications and contribute to treatment fatigue.
By potentially allowing patients to receive injections only twice a year, Eylea 8 mg’s extended dosing interval could transform the therapeutic experience, enabling:
- Reduced clinic visits, lessening burden on patients, caregivers, and healthcare systems
- Improved adherence to treatment, potentially leading to better long-term visual outcomes
- Lower risk of injection-related complications by reducing injection frequency
- Enhanced patient quality of life, with fewer disruptions and increased comfort
This advancement represents a milestone in personalized medicine for retinal diseases, tailoring treatment intervals to patient response and stability while maintaining efficacy and safety.
Regulatory Outlook and Next Steps
Following the CHMP’s positive opinion, the European Commission will issue a final decision on the label extension for Eylea 8 mg within the next few weeks. Upon approval, healthcare providers across the EU will be able to offer patients with nAMD and DME the convenience and clinical benefits of extended 6-month dosing intervals.
Bayer continues to engage with regulatory authorities globally to expand the indications and dosing flexibility for Eylea 8 mg, with ongoing submissions in various markets. The company remains committed to advancing innovative therapies for retinal diseases and addressing unmet patient needs.
About Bayer and Eylea
Bayer is a global enterprise with core competencies in the life science fields of health care and agriculture. Within its Pharmaceuticals division, Bayer focuses on innovative therapies that improve patients’ lives.
Eylea (aflibercept) is an established anti-VEGF treatment used to manage retinal diseases caused by abnormal blood vessel growth and leakage. Since its introduction, Eylea has become a standard of care, supported by extensive clinical evidence and a robust safety profile.
The availability of an 8 mg formulation with an extended dosing interval exemplifies Bayer’s commitment to advancing ophthalmology care through innovation and patient-centric solutions.
In summary, the CHMP’s recommendation for the approval of Eylea™ 8 mg with a 6-month treatment interval extension for nAMD and DME represents a pivotal advancement in the management of retinal diseases in Europe. With anticipated European Commission approval imminent, this new dosing option promises to alleviate the treatment burden for patients while maintaining the high efficacy and safety standards associated with Eylea, positioning it as a leading therapy that could reshape the future landscape of retinal disease management.
