October 10, 2025
1 min read
Key takeaways:
- Eydenzelt is approved for four retinal diseases, including wet age-related macular degeneration and diabetic macular edema.
- This biosimilar received European Commission approval in February.
Editor’s note: This is a developing news story. Please check back soon for updates.
The FDA approved Eydenzelt, a biosimilar referencing Eylea, for the treatment of four retinal diseases, according to a press release from Celltrion.
The FDA approved Eydenzelt, a biosimilar referencing Eylea, for the treatment of four retinal diseases.
These conditions include wet age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema and diabetic retinopathy.
According to the release, the FDA based its decision on Eydenzelt (aflibercept-boav) on analytical, nonclinical and clinical data. Notably, a randomized, double-masked, parallel-group, multicenter, 52-week phase 3 trial found that Eydenzelt demonstrated therapeutic equivalence to Eylea (aflibercept, Regeneron) through predefined criteria in patients with DME, as well as similar efficacy, safety and immunogenicity trends.
Healio previously reported that the Committee for Medicinal Products for Human Use of the European Medicines Agency granted a positive opinion for Eydenzelt in December 2024, and it received European Commission approval in February.
“With Eydenzelt demonstrating biosimilarity to its reference product, we believe this approval will mark a significant milestone in the treatment landscape of retinal diseases — helping physicians broaden their options and improving patient outcomes,” Juby Jacob-Nara, MD, DHSc, MPH, MBA, senior vice president and chief medical officer at Celltrion USA, said in the release.
