Bayer makes EMA application for a pre-filled syringe to administer eye medication Eylea
Berlin: Bayer has submitted an application to the European Medicines Agency (EMA) for a pre-filled syringe to administer Eylea® (aflibercept solution for intravitreal injection) for five retinal conditions. It is currently available in a vial, from which the physicians fill the syringe. If the state-of-the-art pre-filled syringe is approved, it would provide physicians with a new option for treatment that would require fewer steps to prepare for intravitreal injection.
"For many people living with retinal diseases and associated visual impairment, Eylea is a proven treatment option that consistently delivers excellent outcomes in reducing preventable vision loss both in randomized clinical studies and real-world clinical settings," said Dr Michael Devoy, Head of Medical Affairs & Pharmacovigilance of Bayer AG's Pharmaceuticals Division and Bayer Chief Medical Officer. "Bayer is committed to further enhancing its treatment offering through the introduction of the pre-filled syringe."
Eylea has been approved in approximately 100 countries for five indications for adults, which includes the treatment of neovascular (wet) age-related macular degeneration 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). Around 30 million vials of Eylea have been sold since its launch worldwide, resulting in over four million patient-years of experience.
Bayer and Regeneron Pharmaceuticals, Inc. are collaborating on the global development of aflibercept. Regeneron maintains exclusive rights to Eylea in the U.S. Bayer has licensed the exclusive marketing rights outside the U.S., where the companies share equally the profits from sales of Eylea, except for Japan where Regeneron receives a percentage of net sales.
In August 2019, Regeneron received U.S. Food & Drug Administration (FDA) approval for the pre-filled syringe for Eylea.
Next Story
Disclaimer: This site is primarily intended for healthcare professionals. Any content/information on this website does not replace the advice of medical and/or health professionals and should not be construed as medical/diagnostic advice/endorsement or prescription. Use of this site is subject to our terms of use, privacy policy, advertisement policy. © 2020 Minerva Medical Treatment Pvt Ltd