 |
- EYDENZELT® is approved for the treatment of patients with neovascular (wet) age-related macular degeneration (wAMD), macular edema following retinal vein occlusion (RVO), diabetic macular edema (DME), and diabetic retinopathy (DR)
- Celltrion plans to enter the U.S. ophthalmology market to meet diverse needs of patients suffering from various eye conditions
INCHEON, South Korea, Oct. 10, 2025 /PRNewswire/ — Celltrion, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved EYDENZELT® (aflibercept-boav), biosimilar referencing EYLEA® (aflibercept), 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]
Aflibercept is a VEGF inhibitor formulated as an injection for the eye that blocks the growth of new blood vessels and decreases the ability of fluid to pass through blood vessels (vascular permeability) in the eye by blocking VEGF-A and placental growth factor (PlGF), two growth factors involved in ocular angiogenesis.
“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.”
The FDA approval was based on a totality of evidence including analytical, nonclinical, and clinical data. In a randomized, double-masked, parallel-group, multicenter phase III study of EYDENZELT, the efficacy, safety, pharmacokinetics, and immunogenicity of EYDENZELT was compared to EYLEA in patients with diabetic macular edema (DME). The 52-week trial included 348 patients with DME. The primary endpoint was the change in best corrected visual acuity measured at week 8 from baseline, comparing EYDENZELT and EYLEA. Results of the study showed that EYDENZELT met the predefined equivalence criteria, and secondary endpoints of efficacy, safety, and immunogenicity also showed trends similar to EYLEA.
“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, Retina Consultants of Texas Research Centers, Co-chair, 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.”
EYDENZELT is Celltrion’s first FDA-approved biologic product in ophthalmology. EYDENZELT was also approved by the European Commission (EC) in February 2025.
###
About EYDENZELT® (aflibercept-boav)
EYDENZELT® (aflibercept-boav) is a vascular endothelial growth factor (VEGF) inhibitor referencing EYLEA® (aflibercept). EYDENZELT is approved based on a comprehensive data confirming the therapeutic equivalence EYLEA. In the U.S., EYDENZELT is indicated for the treatment of patients with neovascular (wet) age-related macular degeneration (AMD), macular edema following retinal vein occlusion (RVO), diabetic macular edema (DME) and diabetic retinopathy (DR).
INDICATIONS
EYDENZELT® (aflibercept-boav) is indicated for the treatment of patients with:
- Neovascular (Wet) Age-Related Macular Degeneration (AMD)
- Macular Edema Following Retinal Vein Occlusion (RVO)
- Diabetic Macular Edema (DME)
- Diabetic Retinopathy (DR)
IMPORTANT SAFETY INFORMATION
- EYDENZELT is contraindicated in patients with ocular or periocular infections, active intraocular inflammation, and hypersensitivity to aflibercept or any of the excipients in EYDENZELT.
- Instruct patients and/or caregivers to report any signs and/or symptoms suggestive of endophthalmitis, retinal detachment, or retinal vasculitis without delay and should be managed appropriately.
- Increases in intraocular pressure have been seen within 60 minutes of an intravitreal injection. Intraocular pressure and the perfusion of the optic nerve head should be monitored and managed appropriately.
- There is a potential risk of arterial thromboembolic events (ATEs) following intravitreal use of VEGF inhibitors, including aflibercept products. ATEs are defined as nonfatal stroke, nonfatal myocardial infarction, or vascular death (including deaths of unknown cause).
- 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.
For more information, see Full Prescribing Information.
About Celltrion, Inc.
Celltrion, Inc. is a leading biopharmaceutical company that specializes in researching, developing, manufacturing, marketing and sales of innovative therapeutics that improve people’s lives worldwide. Celltrion is a pioneer in the biosimilar space, having launched the world’s first monoclonal antibody biosimilar. Our global pharmaceutical portfolio addresses a range of therapeutic areas including immunology, oncology, hematology, ophthalmology and endocrinology. Beyond biosimilar products, we are committed to advancing our pipeline with novel drugs to push the boundaries of scientific innovation and deliver quality medicines. For more information, please visit our website www.celltrion.com/en-us and stay updated with our latest news and events on our social media: LinkedIn, Instagram, X, and Facebook.
About Celltrion USA
Celltrion USA is Celltrion’s U.S. subsidiary established in 2018. Headquartered in New Jersey, Celltrion USA is committed to expanding access to innovative biologics to improve care for U.S. patients. Celltrion currently has ten biosimilar products approved by the U.S. FDA: INFLECTRA® (infliximab-dyyb), TRUXIMA® (rituximab-abbs), HERZUMA® (trastuzumab-pkrb), VEGZELMA® (bevacizumab-adcd), YUFLYMA®(adalimumab-aaty), AVTOZMA® (tocilizumab-anho), STEQEYMA® (Ustekinumab-stba) STOBOCLO® (denosumab-bmwo), OSENVELT® (denosumab-bmwo), and OMLYCLO® (omalizumab-igec) as well as a novel biologic ZYMFENTRA® (infliximab-dyyb). Celltrion USA will continue to leverage Celltrion’s unique heritage in biotechnology, supply chain excellence and best-in-class sales capabilities to improve access to high-quality biopharmaceuticals for U.S. patients. For more information, please visit www.celltrionusa.com, and stay updated with our latest news and events on our social media: LinkedIn.
FORWARD-LOOKING STATEMENT
Certain information set forth in this press release contains statements related to our future business and financial performance and future events or developments involving Celltrion, Inc. and its subsidiaries that may constitute forward-looking statements, under pertinent securities laws.
These statements may be also identified by words such as “prepares”, “hopes to”, “upcoming”, “plans to”, “aims to”, “to be launched”, “is preparing”, “once gained”, “could”, “with the aim of”, “may”, “once identified”, “will”, “working towards”, “is due”, “become available”, “has potential to”, the negative of these words or such other variations thereon or comparable terminology.
In addition, our representatives may make oral forward-looking statements. Such statements are based on the current expectations and certain assumptions of Celltrion, Inc. and its subsidiaries’ management, of which many are beyond its control.
Forward-looking statements are provided to allow potential investors the opportunity to understand management’s beliefs and opinions in respect to the future so that they may use such beliefs and opinions as one factor in evaluating an investment. These statements are not guarantees of future performance and undue reliance should not be placed on them.
Such forward-looking statements necessarily involve known and unknown risks and uncertainties associated with the company’s business, including the risk factors disclosed in its Annual Report and/or Quarterly Reports, which may cause actual performance and financial results in future periods to differ materially from any projections of future performance or results expressed or implied by such statements.
Celltrion, Inc. and its subsidiaries undertake no obligation to update forward-looking statements if circumstances or management’s estimates or opinions should change except as required by applicable securities laws.
Trademarks
EYDENZELT® is a registered trademark of Celltrion, Inc.
EYLEA® is a registered trademark of Regeneron Pharmaceuticals Inc.
References
[1] EYDENZELT U.S. prescribing information (2025)
US–24-00028
For further information please contact:
Katie Gallagher
kgallagher@jpa.com
+1 617-657-1324
