Celltrion announced on the 3rd that the global phase 3 results demonstrating the 52-week efficacy of the ophthalmic disease treatment "EYDENZELT (development code CT-P42)" have been published in the international journal of ophthalmology, "Ophthalmology and Therapy."
EYDENZELT is a biosimilar of "EYLEA (ingredient name aflibercept)." The global sales of the original drug EYLEA reached $9.523 billion (approximately 13.2 trillion won) last year.
The clinical study results are based on 52-week long-term clinical data from a global phase 3 study conducted on 348 patients with diabetic macular edema (DME). The study compared the therapeutic equivalence, long-term efficacy, and safety between the EYDENZELT group and the original drug group.
According to the study results, both administration groups showed a gradual improvement in maximum corrected visual acuity (BCVA), which was maintained steadily until the 52nd week after improvement compared to the baseline value up to the 16th week, confirming the long-term therapeutic effect of EYDENZELT.
There was no significant difference between the two administration groups in terms of average changes in central retinal thickness and other secondary efficacy evaluation variables as well as safety.
Celltrion also presented the global phase 3 results of EYDENZELT at prestigious international conferences in the ophthalmology field last year, including the "Association for Research in Vision and Ophthalmology (ARVO)" and the "European Retina Meeting (EURETINA)."
The company noted that, as the efficacy and safety data of EYDENZELT have been continuously adopted and made public, the preference and trust of healthcare providers in prescribing it are expected to increase significantly.
Based on the global phase 3 results of EYDENZELT, Celltrion has completed obtaining approvals in major global countries, including Korea, Europe (EC), and Australia. A company official stated, "We will do our best to expedite the remaining commercialization process to ensure that the product can be supplied smoothly in the market."