Celltrion announces phase 3 trial data for EYDENZELT

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Celltrion recently announced 52-week findings from its global phase 3 clinical trial for its ophthalmic treatment candidate, EYDENZELT.¹

EYDENZELT, a biosimilar of EYLEA (aflibercept), is Celltrion’s ophthalmic treatment candidate for the treatment of multiple retinal diseases, including wet age-related macular degeneration (AMD), macular edema following retinal vein occlusion (RVO, branch RVO, or central RVO), diabetic macular edema (DME), and myopic choroidal neovascularization (myopic CNV).²

A total of 348 enrolled patients with DME were included in the randomized, double-masked, parallel-group, multi-center phase 3 trial for the evaluation of EYDENZELT’s therapeutic equivalence, sustained efficacy, and safety when compared to EYLEA.^1,2

Celltrion recently presented results of the study at the 2025 Association for Research in Vision and Ophthalmology (ARVO) and most recently at the European Society of Retina Specialists (EURETINA) 2025 Annual Congress.

Study findings demonstrated both treatment groups had progressive improvement in best-corrected visual acuity (BCVA) from baseline to week 16 and saw stable levels maintained through week 52, demonstrating long-term therapeutic efficacy of EYDENZELT. Findings also noted no significant difference observed between the two groups regarding secondary endpoints, such as average change in central retinal thickness or overall safety outcomes.¹

“The global clinical trial results of EYDENZELT have been recognized and published by prestigious global academic societies and journals, further reinforcing its long-term clinical foundation,” a Celltrion official said in a press release.

“As we continue to obtain regulatory approval in major global markets, we are fully committed to expediting the remaining commercialization process and ensuring a stable and timely supply of the product to the market.”

The phase 3 results have allowed Celltrion to obtain regulatory approval in several major countries, including Korea, the European Commission, and Australia. The company said it has pending approvals in other countries but did not say which countries.

Reference:

1. Kang IH. Celltrion releases 52-week Phase 3 trial results of EYDENZELT for eye disease in international academic journal. Thebionews.net. Published September 4, 2025. Accessed September 5, 2025. https://www.thebionews.net/news/articleViewAmp.html?idxno=17711

2. 셀트리온 Celltrion. 셀트리온 Celltrion. Celltrion.com. Published 2024. Accessed September 5, 2025. https://www.celltrion.com/en-us/company/media-center/press-release/3620