Eylea 8 mg Approved in China for Wet AMD

The Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has approved Eylea 8 mg (aflibercept 8 mg) for the treatment of wet age-related macular degeneration (AMD) in China. The approval is based on positive results from the phase 3 PULSAR trial at week 48, which demonstrated comparable efficacy and safety of Eylea 8 mg with treatment intervals of 3 or 4 months (12 or 16 weeks) compared to standard of care Eylea 2 mg (aflibercept 2 mg) with a fixed bi-monthly (every 8 weeks) interval.

“The approval of Eylea 8 mg in China marks a significant advancement in addressing the need for more durable treatment options for patients, caregivers and ophthalmologists,” Christine Roth, Executive Vice President, Global Product Strategy and Commercialization, and Member of the Pharmaceuticals Leadership Team at Bayer, said in a company news release. “Building on the high therapeutic standard of Eylea 2 mg, patients with wet age-related macular degeneration now have the option to benefit from Eylea 8 mg with long treatment intervals and still experience lasting vision gains, rapid and resilient fluid control, and comparable safety to Eylea 2 mg.”

In the PULSAR trial, Eylea 8 mg met its primary endpoint of noninferior best corrected visual acuity (BCVA) changes with 3- or 4-monthly dosing regimens compared to Eylea 2 mg (aflibercept 2 mg) with a fixed bi-monthly treatment interval at week 48, following initial monthly doses. The safety profile of Eylea 8 mg was consistent with the established safety profile of Eylea 2 mg.

Eylea 8 mg has been approved to date in more than 50 markets for the treatment of wet AMD and DME. Further regulatory applications for Eylea 8 mg in additional markets are ongoing. 

Eylea 8 mg is the only anti-vascular endothelial growth factor-treatment (anti-VEGF) that is approved for extended treatment intervals of up to 5 months for both wet AMD and DME in the EU and UK. In February 2025, Bayer submitted an application to EMA to expand treatment intervals to up to 6 months with Eylea 8 mg for the treatment of wet AMD and DME based on clinical evidence from the PULSAR and PHOTON studies.

Eylea 8 mg (aflibercept 8 mg; in the United States: Eylea HD) is being jointly developed by Bayer and Regeneron. Regeneron maintains exclusive rights to Eylea 2 mg (aflibercept 2 mg) and Eylea HD in the United States. Bayer has licensed the exclusive marketing rights outside the United States, where the companies share equally the profits from sales of Eylea 2 mg and Eylea 8 mg.