Bayer Gets CHMP Nod for Eylea 8 mg in the EU for 2 Major Eye Diseases

Core Viewpoint - Bayer's Eylea 8 mg has received a positive opinion from the CHMP of the EMA for label extension, allowing longer treatment intervals for nAMD and DME, pending European Commission approval [1][2]. Group 1: Product Details - Eylea 8 mg will enable treatment intervals of up to six months for nAMD and DME, making it the only anti-VEGF therapy in the EU with such intervals if approved [2]. - The positive opinion is backed by three-year results from pivotal studies, showing that 24% of nAMD patients and 28% of DME patients achieved a final dosing interval of six months [3]. - Eylea 8 mg has maintained a favorable safety profile over three years, with no new safety concerns reported [5]. Group 2: Market Performance - Bayer's shares have increased by 41.8% year-to-date, contrasting with a 5.2% decline in the industry [2]. - Eylea is a blockbuster drug, currently approved in over 50 markets for nAMD and DME, with ongoing applications for regulatory approvals in additional markets [6]. Group 3: Collaboration and Sales - Bayer co-develops Eylea with Regeneron, which records net product sales in the U.S., while Bayer records sales outside the U.S. [7].