FDA Approves Celltrion’s Eydenzelt, Biosimilar to Aflibercept, to Treat Ocular Conditions

The FDA has approved aflibercept-boav (Eydenzelt; Celltrion), a biosimilar referencing aflibercept (Eylea; Regeneron, Bayer) for the treatment of neovascular (wet) age-related macular degeneration (wAMD), macular edema following retinal vein occlusion (RVO), diabetic macular edema (DME), and diabetic retinopathy (DR).¹

"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, senior vice president and chief medical officer at Celltrion, said in a news release.¹

Eydenzelt’s Role as a Biosimilar to Aflibercept

As a vascular endothelial growth factor (VEGF) inhibitor referencing aflibercept, Eydenzelt is administered as an injection for the eye that blocks the growth of new blood vessels. Additionally, the biosimilar decreases the ability of fluid to pass through blood vessels in the eye by blocking VEGF-A and placental growth factor, which are 2 growth factors included in ocular angiogenesis.¹

“Eydenzelt will be an important new addition to our options for the treatment of our patients with serious retinal diseases,” David M. Brown, MD, FACS, director, Retina Consultants of Texas Research Centers, and cochair, medical leadership board, Retina Consultants of America, said in the news release.¹

Clinical Data Supporting Biosimilar Approval

The approval of Eydenzelt is based on data from the 52-week, randomized, multicenter, phase 3 study (NCT04739306)² that assessed the efficacy, safety, pharmacokinetics, and immunogenicity of Eydenzelt compared to its reference product. A total of 348 patients with DME were included in the study that measured the change in best corrected visual acuity calculated at week 8 from baseline. The results demonstrated that the biosimilar met all predefined equivalence criteria, along with secondary end points of efficacy, safety, and immunogenicity, demonstrating similar results to aflibercept.^1,2

Understanding Age-Related Macular Degeneration and Retinal Diseases

Age-Related Macular Degeneration

AMD affects central vision and can cause severe vision loss, though complete blindness is rare. Individuals aged 50 years and older, smokers, and those with high blood pressure or diets high in saturated fat are at greater risk. While there is no cure available, treatments can help prevent or slow the disease’s progression.³

wAMD is a less common type of AMD and usually leads to more severe vision loss in patients than dry AMD. This primary type of the condition occurs when abnormal blood vessels start to grow beneath the retina, causing them to leak fluid and blood, leading to a large blind spot in the center of the visual field. Symptoms of AMD include blurry or fuzzy vision, difficulty recognizing familiar faces, straight lines appearing wavy, and a dark or empty blind spot in the center of vision.³

"Advanced AMD is a leading cause of irreversible blindness and visual impairment in the world, and nearly 20 million people in the US are living with some form of AMD," Brown explained in the news release.¹

Retinal Diseases

Retinal diseases can affect any part of the retina, which is the thin tissue lining the back of the eye. While diseases can vary, most cause noticeable visual symptoms. DME and DR are both retinal diseases that could cause small blood vessels in the back of the eye to weaken and leak fluid into or under the retina, leading to swelling and blurred or distorted vision among individuals with diabetes.⁴

"Timely access to effective therapies is essential for individuals affected by retinal diseases. We are proud to have Eydenzelt approved by the FDA, and we look forward to expanding the availability and access of biological treatments across the US," Jacob-Nara said in the news release.¹

REFERENCES

1. Celltrion receives U.S. FDA approval for EYDENZELT® (aflibercept-boav), biosimilar referencing EYLEA® (aflibercept). Celltrion. News release. October 10, 2025. Accessed October 10, 2025. https://www.celltrion.com/en-us/company/media-center/press-release/4201

2. Study to Compare Efficacy and Safety of CT-P42 in Comparison With Eylea in Patients With Diabetic Macular Edema. ClinicalTrials.gov identifier: NCT04739306. Updated December 5, 2023. Accessed October 10, 2025. https://clinicaltrials.gov/study/NCT04739306

3. Johns Hopkins Medicine. Age-Related Macular Degeneration (AMD). Accessed October 10, 2025. https://www.hopkinsmedicine.org/health/conditions-and-diseases/agerelated-macular-degeneration-amd

4. Mayo Clinic. Retinal Diseases. March 8, 2024. Accessed October 10, 2025. https://www.mayoclinic.org/diseases-conditions/retinal-diseases/symptoms-causes/syc-20355825