Recommendation is based on the Phase III study FIREFLEYE and data from the follow-up study FIREFLEYE NEXT / Retinopathy of prematurity (ROP) can lead to severe visual impairment and blindness / Bayer will apply for a patent term extension for the patent covering aflibercept, the active ingredient in Eylea™, of six months once the European Commission adopts a decision for a label extension of Eylea
Berlin, November 11, 2022 – The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for a label extension for Eylea™ (aflibercept) for intravitreal injection 40 mg/mL in a prefilled syringe (PFS) for the treatment of preterm infants with retinopathy of prematurity (ROP). The final decision from the European Commission on the label extension is expected in the coming months.*
Currently treatment options are limited. Conventional treatment with laser photocoagulation is associated with the destruction of retinal tissue, which may result in significant long-term complications such as high myopia (nearsightedness) and peripheral vision loss.
“At Bayer, we recognise that families with premature babies with retinopathy of prematurity are waiting for new effective and well tolerated treatment options to spare them from significant visual impairment and even blindness,” said Dr. Christian Rommel, Member of the Executive Committee of Bayer`s Pharmaceutical Division and Head of Research and Development. “Timely treatment in this vulnerable pediatric patient population is crucial and we hope that we will soon be able to provide an additional therapeutic option.”
Globally, it is estimated that each year approximately 50,000 babies born prematurely, who survive the neonatal period, develop vision-threatening ROP. In more serious cases, ROP can lead to blindness secondary to retinal detachment.
“The families of our youngest patients face not only the devastating impact of a premature birth but also the risk that their child may face a life with severe visual impairment. The FIREFLEYE study showed that treatment success with aflibercept 0.4 mg was high and achieved with mostly a single injection per eye in premature babies with severe retinopathy of prematurity,” said Professor Dr. Andreas Stahl, Head of the University Department of Ophthalmology, University Medical Center, Greifswald, Germany.
Bayer will apply for a patent term extension for the European patent covering aflibercept, the active ingredient in Eylea, of six months once the European Commission adopts a decision for a label extension of Eylea. Such an extension would prolong the patent term for that patent to November 2025.
Bayer and Regeneron are collaborating on the global development of aflibercept. Regeneron maintains exclusive rights to Eylea in the United States. Bayer has licensed the exclusive marketing rights outside the United States, where the companies share equally the profits from sales of Eylea.
About Retinopathy of Prematurity (ROP)
In Japan, Eylea® (aflibercept) intravitreal injection 40 mg/mL is approved for the treatment of preterm infants with retinopathy of prematurity (ROP) since September 2022. Retinopathy of prematurity is a vascular disease of the immature retina of preterm babies, characterized by incomplete vessel growth which triggers elevated intraocular levels of vascular growth factor (VEGF) and abnormal vessel growth. Key risk factors include low age and weight at birth. Mild ROP usually resolves spontaneously, while severe forms of ROP require timely treatment. Conventional laser treatment (by photocoagulation) destroys retinal tissue resulting in complications such as high myopia (severe nearsightedness) and peripheral vision loss. The VEGF inhibitor aflibercept injected into the eye targets those elevated intraocular levels of VEGF.
About VEGF and aflibercept solution for injection into the eye
Aflibercept 2 mg solution for injection into the eye, also known under its brand name Eylea®, has been approved in over 100 countries for five indications for adults, which includes the treatment of neovascular (wet) age-related macular degeneration (nAMD) and the treatment of visual impairment due to: macular edema following retinal vein occlusion (RVO; branch RVO or central RVO), diabetic macular edema (DME) and myopic choroidal neovascularization (myopic CNV). Over 58 million vials/pre-filled syringes of Eylea have been sold since its launch worldwide, with more than 8 million patient-years of experience and a well-established ocular and systemic safety profile. Aflibercept 8 mg is investigational, and its safety and efficacy have not yet been evaluated by any regulatory authority.
Vascular Endothelial Growth Factor (VEGF) is a naturally occurring protein in the body. Its normal role in a healthy organism is to trigger formation of new blood vessels (angiogenesis) supporting the growth of the body’s tissues and organs. It is also associated with the growth of abnormal new blood vessels in the eye, which exhibit abnormal increased permeability that leads to edema.
Aflibercept solution for injection is a recombinant fusion protein, consisting of portions of extracellular domains of human VEGF receptors 1 and 2, fused to the Fc portion of human IgG1 and formulated as an iso-osmotic solution for intravitreal administration. Aflibercept acts as a soluble decoy receptor that binds VEGF-A and Placental Growth Factor (PGF) and thereby can inhibit the binding and activation of their cognate VEGF receptors.
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