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

Bayer BAYRY announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending the label extension for Eylea 8 mg (aflibercept) in the EU.This extension will enable longer treatment intervals, up to six months, for two major retinal conditions, neovascular (wet) age-related macular degeneration (nAMD) and diabetic macular edema (DME), pending approval by the European Commission.A decision is anticipated in the coming weeks. If approved, Eylea 8 mg would become the only anti-VEGF therapy in the EU offering treatment intervals of up to six months for both nAMD and DME. Such a decision will also significantly reduce the frequency of injections and clinic visits, which will boost patient compliance and treatment adherence.Year to date, shares of Bayer have surged 41.8% against the industry’s decline of 5.2%.Image Source: Zacks Investment ResearchMore on the Positive CHMP Opinion for BAYRY’s EyleaThe favorable CHMP opinion is supported by positive three-year results from Bayer’s open-label extension studies of the pivotal PULSAR study for nAMD and the PHOTON study for DME. In these studies, patients initially randomized to receive Eylea 8 mg maintained their visual and anatomical improvements over three years. By the end of the studies, 24% of nAMD patients and 28% of DME patients had reached a final dosing interval of six months.Eylea 8 mg continued to demonstrate a favorable safety profile in the third year, consistent with the well-established safety profile of Eylea 2 mg. Long-term safety data revealed no new safety concerns, including among patients who transitioned from Eylea 2 mg to Eylea 8 mg. The incidence of ocular treatment-emergent adverse events was comparable across all treatment groups.Please note that Eylea is a blockbuster drug for treating retinal eye diseases. Eylea 8 mg is currently approved in more than 50 markets for treating nAMD and DME. Several applications seeking the drug’s regulatory approvals in additional markets are ongoing.Eylea 8 mg is also the only anti-VEGF therapy approved in the EU and United Kingdom for extended treatment intervals of up to five months, following three initial monthly injections, for both nAMD and DME.Bayer’s HealthCare unit co-develops Eylea with Regeneron REGN. REGN records net product sales of Eylea in the United States, while BAYRY records net product sales of the drug outside the country. Regeneron also records its share of profits/losses in connection with the sales of Eylea outside the United States.Bayer Aktiengesellschaft Price and Consensus Bayer Aktiengesellschaft price-consensus-chart | Bayer Aktiengesellschaft QuoteBAYRY’s Zacks Rank & Other Stocks to ConsiderBayer currently carries a Zacks Rank #2 (Buy).Some other top-ranked stocks in the biotech sector are Halozyme Therapeutics HALO and Amarin AMRN, each carrying a Zacks Rank #2 at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.In the past 60 days, estimates for Halozyme’s earnings per share have increased from $5.02 to $5.23 for 2025. During the same time, earnings per share estimates for 2026 have increased from $6.56 to $6.77. Year to date, shares of HALO have risen 12.4%.HALO’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 17.60%.In the past 60 days, estimates for Amarin’s loss per share have narrowed from $5.33 to $3.48 for 2025. During the same time, loss per share estimates for 2026 have narrowed from $4.13 to $2.67. Year to date, shares of AMRN have gained 13.3%.AMRN’s earnings beat estimates in two of the trailing four quarters, matched once and missed the same on the remaining occasion, delivering an average surprise of 29.11%.7 Best Stocks for the Next 30 DaysJust released: Experts distill 7 elite stocks from the current list of 220 Zacks Rank #1 Strong Buys. They deem these tickers "Most Likely for Early Price Pops."Since 1988, the full list has beaten the market more than 2X over with an average gain of +23.0% per year. So be sure to give these hand picked 7 your immediate attention. See them now >>Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Regeneron Pharmaceuticals, Inc. (REGN): Free Stock Analysis Report Bayer Aktiengesellschaft (BAYRY): Free Stock Analysis Report Halozyme Therapeutics, Inc. (HALO): Free Stock Analysis Report Amarin Corporation PLC (AMRN): Free Stock Analysis ReportThis article originally published on Zacks Investment Research (zacks.com).Zacks Investment ResearchWeiter zum vollständigen Artikel bei Zacks Weiter zum vollständigen Artikel bei Zacks