Bayer’s Eylea™ 8 mg Receives EMA Recommendation for Extended 6-Month Dosing Interval in Europe
Bayer has announced that the Eylea™ 8 mg 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 extension would allow for expanded treatment intervals of up to six months for two major retinal diseases: neovascular (wet) age-related macular degeneration (nAMD) and diabetic macular edema (DME), pending approval by the European Commission.
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 extension would allow for expanded treatment intervals of up to six months for two major retinal diseases: neovascular (wet) age-related macular degeneration (nAMD) and diabetic macular edema (DME), pending approval by the European Commission.
If approved, Eylea 8 mg would become the only anti-vascular endothelial growth factor (VEGF) treatment in the EU with treatment intervals of up to six months for both nAMD and DME. This advancement could significantly reduce the frequency of injections and clinic visits for patients, potentially improving adherence and overall quality of life.
The CHMP’s positive opinion is based on three-year results from the open-label extension studies of the pivotal clinical trials PULSAR (in nAMD) and PHOTON (in DME). In these studies, patients randomized to Eylea 8 mg at baseline maintained their visual and anatomical improvements, with 24% of nAMD patients and 28% of DME patients achieving a last assigned dosing interval of six months at the end of three years.
Eylea™ 8 mg Demonstrates Sustained Favorable Safety Profile in Long-Term Studies
Eylea™ 8 mg (aflibercept 8 mg) has continued to show a favorable safety profile in its third year of clinical evaluation, reinforcing confidence in its use for the treatment of retinal diseases such as neovascular (wet) age-related macular degeneration (nAMD) and diabetic macular edema (DME). Data from long-term extension studies of the pivotal PULSAR (nAMD) and PHOTON (DME) trials revealed that patients treated with Eylea 8 mg maintained consistent safety outcomes over time.
Importantly, no new safety signals were identified throughout the third year of treatment. This includes data from patients who transitioned from Eylea 2 mg to the higher 8 mg dose, indicating that the change in dosage did not introduce additional risks. The rates of ocular treatment-emergent adverse events were comparable across all study groups, further supporting the overall safety and tolerability of the treatment.
These findings affirm the consistency of Eylea 8 mg’s safety profile with the well-established performance of Eylea 2 mg, which has been widely used in clinical practice. The absence of increased adverse events or unexpected complications provides reassurance for both clinicians and patients considering extended-interval dosing.
As Eylea 8 mg moves toward broader approval in Europe, including a potential six-month dosing interval, this strong safety track record enhances its position as a reliable therapeutic option. The durability and consistency of its safety outcomes are key factors in supporting its expanded use across diverse patient populations.
Eylea™ 8 mg The safety profile of Eylea 8 mg remained favorable in the third year of both studies and was consistent with the well-established safety profile of Eylea 2 mg. No new safety signals were observed, including in patients who switched from Eylea 2 mg to Eylea 8 mg. The rates of ocular treatment-emergent adverse events were similar across all treatment groups.
Eylea 8 mg has been approved in more than 50 markets for the treatment of nAMD and DME. Further regulatory applications for Eylea 8 mg in additional markets are ongoing. Currently, Eylea 8 mg is the only anti-VEGF treatment approved for extended treatment intervals of up to five months (after three initial monthly injections) for both nAMD and DME in the EU and UK.
Eylea™ 8 mg is a global market leader in the treatment of retinal eye diseases with anti-VEGF therapies, with more than 88 million applications and over 12 million patient-years of experience worldwide.
Eylea 8 mg (aflibercept 8 mg; known as Eylea HD in the United States) is being jointly developed by Bayer and Regeneron. Regeneron maintains exclusive rights to Eylea 2 mg and Eylea HD in the United States, while Bayer has licensed exclusive marketing rights outside the United States. The companies share equally in the profits from sales of Eylea 2 mg and Eylea 8 mg outside the United States.
The European Eylea™ 8 mg Commission’s decision on the label extension is expected within the next few weeks. If approved, this extension would mark a significant advancement in the treatment of retinal diseases, offering patients a more convenient dosing schedule without compromising efficacy or safety.
