1. Introduction to Eylea

Eylea (generic name: aflibercept) is a cutting-edge anti-VEGF (vascular endothelial growth factor) therapy designed to treat a range of retinal diseases characterized by abnormal blood vessel growth and fluid leakage. Its primary indications include wet age-related macular degeneration (nAMD), diabetic macular edema (DME), macular edema following retinal vein occlusion (RVO), and other retinal vascular disorders.

Eylea functions as a VEGF trap, binding to VEGF-A, VEGF-B, and placental growth factor (PlGF), effectively inhibiting the pathological angiogenesis and vascular permeability responsible for vision loss in these conditions.

2. Development History

Eylea was originally developed by Regeneron Pharmaceuticals, with Bayer AG serving as the global commercialization partner outside the United States. The drug first gained approval from the U.S. Food and Drug Administration (FDA) in November 2011, marking a major breakthrough in retinal disease treatment. It offered the advantages of broader VEGF inhibition and longer dosing intervals compared to previous therapies.

3. Timeline of Key Approvals Worldwide

Eylea has received regulatory approval across multiple countries, progressively expanding its indication and availability:

Note: Many countries initially approved Eylea for wet AMD and later expanded its use to other retinal conditions like DME and RVO-related macular edema.

4. Dosage and Formulations

The standard dosing regimen of Eylea for wet AMD has traditionally been 2 mg injections every 4 or 8 weeks, following a series of three monthly loading doses. This dosing schedule has helped many patients maintain and improve vision while managing treatment burden.

Most recently, Bayer secured regulatory approval in China for an 8 mg dose of Eylea specifically for wet AMD. This higher dose has the potential to allow longer intervals between injections and may offer improved efficacy and convenience for patients.

Dosage regimens vary globally depending on specific indications and local regulatory approvals.

5. Clinical Impact and Market Penetration

Since its introduction, Eylea has quickly become one of the leading anti-VEGF therapies worldwide. It competes primarily with Regeneron’s Lucentis (ranibizumab) and Genentech’s Avastin (bevacizumab), the latter often used off-label.

Eylea is favored for its longer dosing intervals—up to 12 weeks in some cases—and its proven efficacy in improving and maintaining vision. The therapy has been prescribed to millions of patients globally, significantly reducing rates of blindness and vision impairment from retinal diseases.

6. Key Regulatory Milestones

• FDA (United States): First approval in 2011 for wet AMD, with subsequent label expansions to DME, RVO-related macular edema, and diabetic retinopathy.

• EMA (European Union): Approval followed in 2012, mirroring U.S. indications.

• PMDA (Japan): Approval in 2014 for wet AMD and DME.

• NMPA (China): Initially approved Eylea 2 mg for diabetic retinopathy and DME. The 8 mg dose for wet AMD was approved recently in 2025.

• Other countries have granted approvals based on both regional clinical trial data and extensive global evidence.

7. Summary

Latest Milestone: China Approves Eylea 8 mg for Wet AMD

In a landmark regulatory decision, China’s National Medical Products Administration (NMPA) approved the 8 mg dose of Eylea for the treatment of wet age-related macular degeneration (nAMD) in May 2025. This approval follows the positive results of the global Phase III PULSAR trial, which demonstrated that the 8 mg dose administered every 3 to 4 months is as effective and safe as the standard 2 mg dose given every 8 weeks.

This approval not only brings a significant advancement in ophthalmic care for millions of Chinese patients but also highlights the global trend towards longer-acting, patient-friendly treatments in retinal disease management.