Eylea 8 mg Receives Approval in China for Wet Age-Related Macular Degeneration

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). This regulatory milestone is based on results from the pivotal phase 3 PULSAR trial, which demonstrated that Eylea 8 mg maintains comparable efficacy and safety with dosing intervals extended to every 3 or 4 months (12 or 16 weeks), compared to the standard Eylea 2 mg regimen administered every 8 weeks.

A New Option for Extended Dosing Intervals

Eylea 8 mg offers a more durable treatment alternative for wet AMD, helping to reduce the frequency of injections without compromising visual outcomes.

“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,” said Christine Roth, Executive Vice President, Global Product Strategy and Commercialization at Bayer.
“Building on the high therapeutic standard of Eylea 2 mg, patients with wet AMD 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.”

PULSAR Trial Findings

The PULSAR study was a global, randomized phase 3 trial evaluating best corrected visual acuity (BCVA) outcomes in patients receiving either:

       • Eylea 8 mg every 12 or 16 weeks

       • Eylea 2 mg every 8 weeks
          Following initial monthly loading doses, Eylea 8 mg met its primary endpoint of noninferiority in BCVA  at week 48, with a safety profile consistent with that of the 2 mg formulation.

Global Approvals and Ongoing Submissions

Eylea 8 mg has now been approved in over 50 markets for the treatment of wet AMD and diabetic macular edema (DME). Regulatory applications are actively underway in additional countries.

Development and Commercial Partnership

Eylea 8 mg (aflibercept 8 mg), known as Eylea HD in the United States, is being jointly developed by Bayer and Regeneron:

       • Regeneron holds exclusive U.S. rights to both Eylea 2 mg and Eylea HD.

       • Bayer holds exclusive marketing rights outside the U.S., and both companies share profits equally from sales of both 2 mg and 8 mg formulations globally.