FDA Approves Celltrion’s EYDENZELT® Biosimilar: A New, Affordable Treatment for Retinal Diseases

Celltrion’s biosimilar “EYDENZELT” has received approval from the U.S. Food and Drug Administration (FDA), marking a significant advance in treatment options for several vision-threatening eye disorders, with broad implications for patients and the healthcare system alike.​

Landmark FDA Approval: What Happened and Why It Matters

On October 9, 2025, the U.S. FDA approved EYDENZELT (aflibercept-boav), a biosimilar referencing the established therapy EYLEA (aflibercept), for multiple retinal diseases. This approval provides U.S. patients with a new, cost-effective biologic option to treat conditions such as:​

• Neovascular (wet) age-related macular degeneration (wAMD)

• Macular edema following retinal vein occlusion (RVO)

• Diabetic macular edema (DME)

• Diabetic retinopathy (DR)​

Celltrion, a South Korea-based biopharmaceutical firm, now has 11 biosimilars approved globally. This is their first FDA-approved ophthalmology product, coming on the heels of recent approvals from the European Commission and Australia.​

Key Findings and Regulatory Review

EYDENZELT’s FDA review was based on a “totality of evidence,” which included analytical, nonclinical, and clinical data demonstrating similarity to the reference product. The pivotal evidence came from a global, randomized, double-masked, phase III clinical trial involving 348 adults with diabetic macular edema.

Study highlights:

• Primary endpoint: Change in best-corrected visual acuity (BCVA) at 8 weeks from baseline—EYDENZELT met predefined equivalence versus EYLEA

• Secondary endpoints: No significant differences in central retinal thickness, overall safety, or immunogenicity

• Study duration: 52 weeks, with both groups showing equivalent sustained efficacy and safety trends​

Mechanism of Action and Clinical Context

EYDENZELT is a VEGF (vascular endothelial growth factor) inhibitor, administered via eye injection. By inhibiting VEGF, it curbs the growth of abnormal blood vessels and fluid leakage in the retina – processes central to the vision loss seen in wet AMD and diabetic eye diseases.​

Retinal disorders such as wAMD are leading causes of irreversible blindness worldwide, and nearly 20 million people in the U.S. live with some form of macular degeneration. The global market for EYLEA exceeded $9 billion in 2024, highlighting the unmet need for affordable, high-quality alternatives.​

Expert Commentary

Dr. Juby Jacob-Nara, Senior Vice President and Chief Medical Officer at Celltrion, commented, “Timely access to effective therapies is essential for individuals affected by retinal diseases… 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”.​

Independent experts also welcomed the development. Dr. David M. Brown, Director at Retina Consultants of Texas Research Centers, noted, “EYDENZELT will be an important new addition to our options for the treatment of our patients with serious retinal diseases”.​

Public Health and Cost Implications

Biosimilars are designed to offer the same efficacy, safety, and quality as their reference biologics—but often at a lower cost. EYDENZELT’s entry into the U.S. market could spur price competition, improve access, and reduce healthcare spending for these common, debilitating eye diseases.​

As more biosimilars gain approval, physicians and payers are expected to increase their reliance on these agents, especially as robust data support their equivalence in outcomes.

Side Effects, Limitations, and Counterpoints

The most commonly reported side effects with aflibercept biosimilars include conjunctival hemorrhage, eye pain, cataract, vitreous detachment, floaters, and increased intraocular pressure. Physicians are reminded to assess each patient individually.​

While biosimilars are rigorously reviewed for similarity, long-term real-world surveillance is necessary to identify rare adverse events and confirm consistent performance outside clinical trials. Furthermore, some ophthalmology experts advise ongoing patient education to foster confidence in biosimilar efficacy.

Practical Takeaways for Patients and Providers

Patients with retinal diseases now have a promising new treatment alternative that may expand access and affordability. Healthcare professionals can expect further biosimilar options as regulatory agencies encourage competition.

However, decisions on switching therapies or initiating a biosimilar must consider individual patient needs and should involve shared decision-making in the clinic.

Medical Disclaimer

Medical Disclaimer: This article is for informational purposes only and should not be considered medical advice. Always consult with qualified healthcare professionals before making any health-related decisions or changes to your treatment plan. The information presented here is based on current research and expert opinions, which may evolve as new evidence emerges.

References

1. Celltrion receives U.S. FDA approval for EYDENZELT® (aflibercept-boav), biosimilar referencing EYLEA® (aflibercept). Celltrion Press Release, October 9, 2025. https://www.celltrion.com/en-us/company/media-center/press-release/4201celltrion​