Bayer Announces EU Approval of Eylea™ 8 mg with Extended 6-Month Dosing Interval for nAMD and DME

China Finance Network July 2nd: The European Commission (EC) has approved the label extension of Eylea 8mg (Aflibercept 8mg, 114.3mg/ml injection) in the EU, extending the treatment interval up to 6 months for the treatment of two major retinal diseases: neovascular (wet) age-related macular degeneration (nAMD) and vision impairment caused by diabetic macular edema (DME).

Eylea 8mg is the first and only anti-vascular endothelial growth factor (VEGF) in the EU with a treatment interval of up to 6 months for patients with nAMD and DME.

Christine Roth, Member of the Bayer Prescription Medicines Leadership Team, Executive Vice President, and Head of Global Product Strategy and Commercialization, stated that extending the treatment interval of Eylea 8mg can significantly reduce the frequency of injections and outpatient follow-ups for patients without compromising efficacy. This will alleviate the disease burden on patients and improve treatment adherence. For ophthalmologists, it can enhance the ability to treat more patients. "Given its unique product characteristics, Eylea 8mg has the potential to establish a new standard of care for retinal diseases."

The European Commission's decision was based on the positive results from the three-year treatment in the open-label extension studies of the pivotal clinical trials PULSAR (nAMD) and PHOTON (DME). During the two extension phases (weeks 96 to 156 of the study), patients initially randomized at week 0 to receive Eylea 8mg maintained their improvements in vision and anatomical outcomes, with 24% of nAMD patients and 28% of DME patients having a final prescribed dosing interval of six months at the end of three years.

In the above two studies, Eylea 8mg maintained good safety in the third year, consistent with the confirmed safety of Eylea 2mg. The long-term safety data from the two trials did not show any new safety signals, including patients who switched from Eylea 2mg to Eylea 8mg treatment at week 96. The incidence of ocular adverse events was similar across all treatment groups.

Eylea 8mg (Aflibercept 8mg) has been approved in more than 60 markets for the treatment of nAMD and DME. Further registration applications for Eylea 8mg are ongoing in other markets.

Eylea 8mg (Aflibercept 8mg, known as Eylea HD in the U.S.) was jointly developed by Bayer and Regeneron. Regeneron has exclusive rights to Eylea 2mg (Aflibercept 2mg) and Eylea HD in the United States. Bayer holds exclusive marketing rights outside the U.S., and the two companies equally share the sales profits of Eylea 2mg and Eylea 8mg.