Eylea has already been approved in
The application for approval was based on the results of the FIREFLEYE study, a global phase 3 study investigating the efficacy and safety of Eylea administered intravitreally in an ROP patient group that included Japanese patients. The findings from the FIREFLEYE study were published in the
ROP is a vascular disease of the immature retina of babies born prematurely, and can lead to visual impairment and blindness in children. 1,2 The number of patients in
'Due to the development of perinatal care, more premature babies are surviving, which is increasing the number of ROP cases and also the number of severe cases. ROP can lead to serious visual impairment and blindness and requires timely treatment,' said Dr.
Eylea will be distributed in
About FIREFLEYE study
The FIREFLEYE study is a global phase 3 study investigating the efficacy and safety of Eylea compared with retinal photocoagulation, the standard of care, in patients with retinopathy of prematurity (ROP). Eylea showed a favorable benefit-risk profile in 113 patients, including Japanese patients, with ROP. The study assessed the non-inferiority of Eylea 0.4 mg to retinal photocoagulation with respect to success criterion outside of
About Retinopathy of Prematurity (ROP)
Retinopathy of prematurity (ROP) is a vascular disease of the immature retina in babies born prematurely. Major risk factors for onset include short gestational age and low birth weight. Incomplete vessel growth triggers elevated intraocular levels of vascular endothelial growth factor (VEGF) and abnormal vessel growth. Mild ROP usually resolves spontaneously, while severe forms of ROP may lead to decreased vision or blindness and require timely treatment.
About VEGF aflibercept solution for injection into the eye
Vascular Endothelial Growth Factor (VEGF) is a naturally occurring human protein that plays a role in promoting the formation of new blood vessels (angiogenesis) that support growth of body tissue and organs. It is also associated with the growth of abnormal new blood vessels in the eye, which exhibit abnormally elevated vessel permeability leading to edema.
Eylea is a recombinant fusion glycoprotein, consisting of portions of human VEGF receptors 1 and 2 extracellular domains fused to the Fc domain of human IgG1, and formulated as an iso-osmotic solution for intravitreal administration. Eylea acts as a soluble decoy receptor that by binding VEGF-A and Placental Growth Factor (PIGF) can inhibit the binding and activation of their cognate VEGF receptors.
About Bayer
Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. Its products and services are designed to help people and planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to drive sustainable development and generate a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2021, the Group employed around 100,000 people and had sales of
About
As a specialized company dedicated to eye health,
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