• 27 May 2025
• Admin
• News Article

Bayer announces EMA committee recommends label extension approval for Eylea 8 mg

Bayer has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending a label extension for Eylea 8 mg (aflibercept 8 mg).

This extension would allow treatment intervals of up to 6 months for two major retinal conditions:

• Neovascular (wet) age-related macular degeneration (nAMD)
• Diabetic macular edema (DME)

A final decision from the European Commission is expected in the coming weeks.

What This Means for Patients

• If approved, Eylea 8 mg will become the only anti-VEGF therapy in the EU offering up to 6-month treatment intervals for both nAMD and DME.
• This change can significantly reduce the number of injections and clinic visits, improving treatment convenience and quality of life.

“Extended treatment intervals with Eylea 8 mg of up to 6 months can significantly reduce the frequency of injections and visits,”

— Christine Roth, EVP, Global Product Strategy & Commercialization, Bayer

Clinical Evidence Supporting the Label Extension

Based on 3-Year PULSAR and PHOTON study results:

• The CHMP opinion is supported by positive data from open-label extension studies:
  • PULSAR study – focused on nAMD
  • PHOTON study – focused on DME
• Results at year 3 showed:
  • 24% of nAMD patients and 28% of DME patients were maintained at 6-month dosing intervals.
  • Patients maintained stable visual and anatomical improvements.
  • Favorable safety profile consistent with the established Eylea 2 mg.

Safety Profile Remains Strong

• No new safety signals were observed in patients switching from Eylea 2 mg to Eylea 8 mg.
• The incidence of ocular treatment-emergent adverse events was similar across treatment groups.

Regulatory Status and Global Reach

Approved in 50+ Markets and Counting

• Eylea 8 mg has already been approved in over 50 markets for both nAMD and DME.
• Additional regulatory filings are ongoing in other regions.
• Currently, it is the only anti-VEGF therapy approved for up to 5-month intervals (after 3 initial monthly injections) for both indications in the EU and UK.

Market Leadership and Global Experience

• Eylea is a global leader in anti-VEGF treatments for retinal diseases.
• With:
  • Over 88 million applications
  • More than 12 million patient-years of experience worldwide

Disease Background

Neovascular (Wet) Age-Related Macular Degeneration (nAMD)

• A fast-progressing retinal disease that can cause irreversible blindness within months if untreated.
• Caused by abnormal blood vessel growth under the macula.
• Affects around 10% of people with AMD, with 170 million currently living with AMD globally.
• The number is projected to reach 288 million by 2040.

Diabetic Macular Edema (DME)

• A serious complication of diabetic retinopathy (DR).
• Occurs when damaged blood vessels leak fluid into the macula due to prolonged high blood sugar.
• May lead to vision loss or blindness.
• Globally:
  • 146 million people have diabetic retinopathy
  • Around 27 million suffer from DME

About Eylea and Its Developers

• Eylea 8 mg is known in the United States as Eylea HD.
• Jointly developed by Bayer and Regeneron:
  • Regeneron retains exclusive rights in the U.S.
  • Bayer holds rights outside the U.S., with both companies sharing profits from Eylea 2 mg and 8 mg..

Key Highlights

• Eylea 8 mg poised to become first in EU with 6-month intervals for nAMD & DME.
• Strong 3-year efficacy & safety data from PULSAR and PHOTON.
• Currently approved in 50+ countries, with more applications pending.
• Potential to set a new standard of care for retinal diseases.