Drug Discovery and Development

  • Home Drug Discovery and Development
  • Drug Discovery
  • Women in Pharma and Biotech
  • Oncology
  • Neurological Disease
  • Infectious Disease
  • Resources
    • Video features
    • Podcast
    • Voices
    • Webinars
  • Pharma 50
    • 2025 Pharma 50
    • 2024 Pharma 50
    • 2023 Pharma 50
    • 2022 Pharma 50
    • 2021 Pharma 50
  • Advertise
  • SUBSCRIBE

Regeneron’s Eylea approved for preterm infants with ROP, first drug treatment for condition

By Brian Buntz | February 9, 2023

Regeneron Pharmaceuticals in the Drug Discovery & Development Pharma 50Regeneron Pharmaceuticals (Nasdaq:REGN) has received an indication for Eylea (aflibercept) injection for preterm infants with retinopathy of prematurity (ROP). 

The approval is the first pharmacologic treatment for the condition, which affects roughly 50% to 70% of infants with a weight less than 1250 grams (2.76 pounds) at birth. The condition is more common in infants born before 31 weeks of pregnancy. 

The condition is a common cause of childhood blindness. 

A growing number of indications

FDA first approved Eylea for wet age-related macular degeneration in 2011. Indications followed for diabetic macular edema, macular edema following retinal vein occlusion and diabetic retinopathy in patients with diabetic macular edema.

The approval is based on data from two global Phase 3 trials, FIREFLEYE and BUTTERFLEYE. The studies compared EYLEA to laser photocoagulation in infants with ROP. The data showed that approximately 80% of EYLEA-treated infants had an absence of active ROP and unfavorable structural outcomes at 52 weeks, better than expected without treatment. In addition, no new safety signals were observed in either trial, which tested a 0.4 mg dose of aflibercept. 

Regeneron noted in October that FDA granted Priority Review of the supplemental Biologics License Application (sBLA) for aflibercept injection to treat ROP in preterm infants.

EYLEA is jointly developed by Regeneron and Bayer, with Regeneron maintaining rights to distribute the drug in the U.S. and Bayer holding rights elsewhere. 

In the third quarter of 2022, Eylea’s sales growth of 11% exceeded the VEGF inhibitor class growth of 4%. 

The drug generated $9.2 billion for Regeneron and Bayer in 2021. 

More competition

In 2022, Roche won FDA approval for Vabysmo, a longer-acting VEGF inhibitor. Analysts at Evaluate project the drug will have $1.1 billion in sales by 2026. 

Regeneron hopes to fend off the competition with a higher-dose version of Eylea. Last year, the company shared the results of two late-stage trials demonstrating that an 8 mg dose of aflibercept offered sustained treatment intervals in patients with neovascular eye disease.

The company anticipates winning FDA approval for the higher-dose version of the drug later this year. 

Viatris (Nasdaq:VTRS) and Momenta Pharmaceuticals, a subsidiary of Johnson & Johnson (NYSE:JNJ), are collaborating on developing MYL-1701P, a biosimilar of aflibercept.


Filed Under: Ophthalmology
Tagged With: Eylea
 

About The Author

Brian Buntz

As the pharma and biotech editor at WTWH Media, Brian has almost two decades of experience in B2B media, with a focus on healthcare and technology. While he has long maintained a keen interest in AI, more recently Brian has made making data analysis a central focus, and is exploring tools ranging from NLP and clustering to predictive analytics.

Throughout his 18-year tenure, Brian has covered an array of life science topics, including clinical trials, medical devices, and drug discovery and development. Prior to WTWH, he held the title of content director at Informa, where he focused on topics such as connected devices, cybersecurity, AI and Industry 4.0. A dedicated decade at UBM saw Brian providing in-depth coverage of the medical device sector. Engage with Brian on LinkedIn or drop him an email at bbuntz@wtwhmedia.com.

Related Articles Read More >

AMD
Promising phase 2 data suggests new drug could save sight in dry AMD
Structure of human eye. In side view.
Gene therapy yields 100x vision average improvement, with a few reaching 10,000x
Ozempic
JAMA study suggests link between semaglutide and eye disorder
Retina slice
Molecular photoswitches: Illuminating the future of inherited retinal disease treatment
“ddd
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest news and trends happening now in the drug discovery and development industry.

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
Drug Discovery and Development
  • MassDevice
  • DeviceTalks
  • Medtech100 Index
  • Medical Design Sourcing
  • Medical Design & Outsourcing
  • Medical Tubing + Extrusion
  • Subscribe to our E-Newsletter
  • Contact Us
  • About Us
  • R&D World
  • Drug Delivery Business News
  • Pharmaceutical Processing World

Copyright © 2025 WTWH Media LLC. All Rights Reserved. The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media
Privacy Policy | Advertising | About Us

Search Drug Discovery & Development

  • Home Drug Discovery and Development
  • Drug Discovery
  • Women in Pharma and Biotech
  • Oncology
  • Neurological Disease
  • Infectious Disease
  • Resources
    • Video features
    • Podcast
    • Voices
    • Webinars
  • Pharma 50
    • 2025 Pharma 50
    • 2024 Pharma 50
    • 2023 Pharma 50
    • 2022 Pharma 50
    • 2021 Pharma 50
  • Advertise
  • SUBSCRIBE