Celltrion: Eydenzelt 52-Week Clinical Results Demonstrate Long-Term Therapeutic Efficacy

Celltrion announced on September 3 that the 52-week results from the global Phase 3 clinical trial of its biosimilar to the ophthalmic disease treatment 'Eylea' (active ingredient: aflibercept), named 'Eydenzelt' (development code: CT-P42), have been published in the international ophthalmology journal 'Ophthalmology and Therapy.'

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The newly released research results are long-term 52-week clinical data from Celltrion's global Phase 3 trial involving 348 patients with diabetic macular edema (DME).

This clinical trial evaluated and compared the therapeutic equivalence, long-term efficacy, and safety between the Eydenzelt group and the original drug group. According to the study results, both groups experienced a gradual improvement in best corrected visual acuity (BCVA) from baseline up to week 16, which was then stably maintained through week 52. Celltrion stated that these findings demonstrate the long-term therapeutic efficacy of Eydenzelt.

Additionally, there were no significant differences between the two groups in other secondary efficacy endpoints, such as the mean change in central retinal thickness, or in terms of safety.

Celltrion noted that last year, it also presented the global Phase 3 results for Eydenzelt at the Association for Research in Vision and Ophthalmology (ARVO) and the European Society of Retina Specialists (EURETINA), both globally recognized ophthalmology societies. The company expects that, as Eydenzelt's efficacy and safety data continue to be adopted and published, physicians' preference and trust in prescribing the drug will further increase.

Based on the global Phase 3 results for Eydenzelt, Celltrion has completed regulatory approvals in major markets, including South Korea, the European Commission (EC), and Australia.

The original drug, Eylea, is a blockbuster treatment for ophthalmic diseases and recorded global sales of 9.523 billion dollars (approximately 13.3322 trillion won) last year.

A Celltrion representative stated, "As we continue to secure product approvals in major global markets, we will do our utmost to expedite the remaining commercialization processes so that the product can be smoothly supplied to the market."

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