Celltrion Reports Phase 3 Results for EYDENZELT

Celltrion has announced 52-week results from its global Phase 3 clinical trial evaluating EYDENZELT, a biosimilar to aflibercept (EYLEA), for the treatment of diabetic macular edema (DME) and other retinal diseases. The data were recently presented at both the 2025 Association for Research in Vision and Ophthalmology (ARVO) Meeting and the EURETINA 2025 Annual Congress.

EYDENZELT: A Biosimilar Targeting Multiple Retinal Diseases

EYDENZELT is Celltrion’s ophthalmic treatment candidate developed as a biosimilar to EYLEA (aflibercept). The therapy is intended for the treatment of a broad spectrum of retinal conditions, including wet age-related macular degeneration (AMD), macular edema following retinal vein occlusion (RVO), both branch and central types, diabetic macular edema (DME), and myopic choroidal neovascularization (myopic CNV).

Phase 3 Trial Overview

The randomized, double-masked, parallel-group, multicenter Phase 3 study enrolled 348 patients with DME. The trial aimed to evaluate the therapeutic equivalence, sustained efficacy, and safety of EYDENZELT in comparison to the reference product, EYLEA.

Study findings demonstrated that both EYDENZELT and EYLEA treatment groups experienced progressive improvement in best-corrected visual acuity (BCVA) from baseline to Week 16, with these visual gains maintained through Week 52, confirming long-term therapeutic efficacy. Additionally, there were no significant differences observed between the two groups in secondary endpoints, including average change in central retinal thickness and overall safety outcomes.

Regulatory Milestones and Market Outlook

According to Celltrion, the positive Phase 3 data have supported regulatory approvals in several key markets, including South Korea, the European Commission and Australia.

Regulatory submissions are also pending in additional countries, although specific regions have not been disclosed.

Company Statement on Clinical Impact and Commercial Strategy

A Celltrion official commented on the broader implications of the study:

“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.”

The company also highlighted its commitment to market readiness:

“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.”