The Korean drug regulator has approved a phase-3 clinical trial on Eylea (ingredient: aflibercept), an anti-vascular endothelial growth factor (anti-VEGF) injection, for the treatment of retinopathy of prematurity (ROP) in premature babies.
|Bayer’s macular degeneration treatment Eylea|
The Ministry of Food and Drug Safety on Monday granted Bayer Korea to go ahead with the phase-3 study on Eylea.
The study will evaluate the long-time result of 100 participants, including three Koreans who receive ROP treatment. Samsung Medical Center, Asan Medical Center, and Soonchunhyang University Cheonan Hospital will participate in the study.
Eylea is an anti-VEGF injection, treating macular degeneration. Globally, Bayer has been conducting the phase-3 study since June to confirm whether Eylea will prevent blindness in premature infants with ROP.
ROP occurs in premature infants who have incomplete development of blood vessels for the retina. It is one of the major causes of blindness in children.
In Korea, Eylea is indicated for neovascular wet age-related macular degeneration as well as visual impairments caused by retinal vein occlusion, diabetic macular edema, and choroidal neovascularization due to pathological myopia.