Celltrion Receives FDA Approval for EYDENZELT, First Aflibercept Biosimilar for Retinal Diseases
核心洞察
Celltrion's EYDENZELT (aflibercept-boav (搜索)) becomes the first FDA-approved biosimilar to EYLEA for treating multiple retinal diseases including wet AMD, diabetic macular edema (搜索), and diabetic retinopathy (搜索).
The approval was based on a 52-week phase III trial with 348 DME patients that demonstrated therapeutic equivalence to the reference product EYLEA across efficacy, safety, and immunogenicity endpoints.
EYDENZELT marks Celltrion's entry into the U.S. ophthalmology market and represents a significant milestone for expanding patient access to VEGF (搜索) inhibitor treatments for serious retinal conditions.
Celltrion announced that the U.S. Food and Drug Administration has approved EYDENZELT (aflibercept-boav (搜索)), the first biosimilar referencing EYLEA (aflibercept), for treating multiple retinal diseases. The approval covers neovascular (wet) age-related macular degeneration (wAMD), macular edema following retinal vein occlusion (搜索) (RVO), diabetic macular edema (搜索) (DME), and diabetic retinopathy (搜索) (DR).
Clinical Trial Foundation
The FDA approval was supported by comprehensive analytical, nonclinical, and clinical data from a randomized, double-masked, parallel-group, multicenter phase III study. The 52-week trial enrolled 348 patients with diabetic macular edema (搜索) to evaluate EYDENZELT's efficacy, safety, pharmacokinetics, and immunogenicity compared to EYLEA.
The primary endpoint measured the change in best corrected visual acuity at week 8 from baseline. Results demonstrated that EYDENZELT met the predefined equivalence criteria, with secondary endpoints of efficacy, safety, and immunogenicity showing trends similar to EYLEA.
Study findings presented at the 2025 Association for Research in Vision and Ophthalmology (ARVO) and European Society of Retina Specialists (EURETINA) conferences showed both treatment groups had progressive improvement in best-corrected visual acuity from baseline to week 16, with stable levels maintained through week 52. No significant differences were observed between the two groups regarding secondary endpoints, including average change in central retinal thickness or overall safety outcomes.
Mechanism of Action and Clinical Significance
EYDENZELT is a VEGF (搜索) inhibitor formulated as an injection for the eye that blocks the growth of new blood vessels and decreases vascular permeability by blocking VEGF-A (搜索) and placental growth factor (搜索) (PlGF), two growth factors involved in ocular angiogenesis.
"Advanced age-related macular degeneration (AMD) is a leading cause of irreversible blindness and visual impairment in the world and nearly 20 million people in the U.S. are living with some form of age-related macular degeneration," said Dr. David M. Brown, Director of Retina Consultants of Texas Research Centers and Co-chair of the Medical Leadership Board Retina Consultants of America. "EYDENZELT will be an important new addition to our options for the treatment of our patients with serious retinal diseases."
Market Entry and Access
This approval represents Celltrion's first FDA-approved biologic product in ophthalmology and marks the company's entry into the U.S. ophthalmology market. EYDENZELT was previously approved by the European Commission in February 2025.
"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 U.S.," said Dr. Juby Jacob-Nara, Senior Vice President and Chief Medical Officer at Celltrion USA. "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."
Safety Profile
The most common adverse reactions (≥5%) reported in patients receiving aflibercept were conjunctival hemorrhage, eye pain, cataract, vitreous detachment, vitreous floaters, and intraocular pressure increased. EYDENZELT is contraindicated in patients with ocular or periocular infections, active intraocular inflammation, and hypersensitivity to aflibercept or any excipients.
Global Regulatory Progress
Celltrion has obtained regulatory approval for EYDENZELT in several major countries, including Korea, the European Commission, and Australia, with pending approvals in additional markets. A Celltrion official stated that the company is "fully committed to expediting the remaining commercialization process and ensuring a stable and timely supply of the product to the market."