[Song Young Doo, Edaily Repoeter] Celltrion announced on Sept. 3 that results from the 52-week global Phase 3 trial of Eydenzelt, its biosimilar to Eylea(aflibercept), have been published in the international ophthalmology journal Ophthalmology and Therapy.
The study evaluated 348 patients with diabetic macular edema(DME), comparing Eydenzelt with the reference drug in terms of efficacy, long-term outcomes, and safety. Results showed that best-corrected visual acuity(BCVA) improved progressively through week 16 and was sustained through week 52 in both groups, confirming the long-term therapeutic efficacy of Eydenzelt. No significant differences were observed in secondary endpoints, such as mean changes in central retinal thickness, or in safety profiles.
Before this publication, Celltrion had already presented the Phase 3 results at major global ophthalmology conferences, including the Association for Research in Vision and Ophthalmology(ARVO) and the European Society of Retina Specialists(EURETINA). With repeated validation of efficacy and safety data in prominent journals and conferences, the company expects physician confidence and prescribing preference to further increase.
Based on these results, Celltrion has obtained marketing approvals in Korea, the European Union, and Australia, with applications pending in other key markets. Once approvals are finalized, the company plans to accelerate commercialization to expand market share. The reference drug Eylea, a blockbuster ophthalmic treatment, generated global sales of $9.52 billion in 2023(about 13.3 trillion won).
A Celltrion spokesperson said, “The publication of long-term clinical results in a leading international journal further validates the therapeutic value of Eydenzelt. With product approvals being secured in major global markets, we will expedite remaining commercialization steps to ensure timely supply to patients worldwide.”
