Regeneron Pharmaceuticals Receives FDA Complete Response Letter on EYLEA HD Extended Dosing Proposal
TARRYTOWN, N.Y., April 18, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) announced today that the U.S. Food and Drug Administration (FDA) has issued a complete response letter (CRL) concerning the companys supplemental Biologics License Application (sBLA). This application sought to approve the addition of extended dosing intervals for the EYLEA HD (aflibercept) Injection 8 mg, proposing intervals of up to 24 weeks across all indications.
The FDA's CRL did not indicate any concerns regarding the safety or efficacy of the EYLEA HD treatment in its currently approved indications and dosing regimens. However, the agency did not accept Regenerons request for the proposed extended dosing intervals beyond the existing maximum of 16 weeks, which is the limit stated on the products label. In light of the FDA's decision, Regeneron is currently evaluating its options moving forward and will outline a further plan at a later date.
EYLEA HD is specifically approved for administration at intervals ranging from every 8 to 16 weeks for patients suffering from wet age-related macular degeneration (wAMD) and diabetic macular edema (DME). For patients with diabetic retinopathy (DR), the current recommendation allows for dosing every 8 to 12 weeks following three initial monthly doses of the drug.
About EYLEA HD
Initially introduced over a decade ago, EYLEA is a vascular endothelial growth factor (VEGF) inhibitor that has significantly altered the treatment landscape for serious chorioretinal vascular diseases. The drug boasts a proven efficacy and an established safety profile, supported by results from 16 pivotal clinical trials. It is approved for treating critical vision-threatening conditions, ranging from retinopathy of prematurity (ROP) in infants to diabetic macular edema (DME) affecting adults.
Designed to improve upon its predecessor, EYLEA HD was developed with the aim of providing comparable efficacy and safety while reducing the frequency of injections required by patients. This innovative treatment is backed by a robust body of research and is currently approved in the U.S. for treating wAMD, DME, and DR.
Regeneron collaborates with Bayer AG in the development of EYLEA HD, although Regeneron retains exclusive rights to the product within the United States. Under a licensing agreement, Bayer holds exclusive marketing rights outside the U.S., and the two companies split the profits generated from EYLEA and EYLEA HD sales.
Regenerons Commitment to Ophthalmology
Regeneron is dedicated to pioneering advancements in eye care to enhance the quality of life for millions of Americans affected by vision-threatening conditions. The company's extensive expertise in angiogenesis research forms the bedrock of its ongoing commitment to innovate and create new solutions for patients. The companys diverse and comprehensive research and development portfolio in ophthalmology includes initiatives aimed at tackling additional severe eye diseases, including geographic atrophy, glaucoma, and inherited retinal diseases, with ongoing trials such as the Phase 3 SIENNA study.
Important Safety Information and Indications
EYLEA HD (aflibercept) Injection 8 mg is a prescription medicine authorized for the treatment of Wet Age-Related Macular Degeneration (AMD), Diabetic Macular Edema (DME), and Diabetic Retinopathy (DR). EYLEA (aflibercept) Injection 2 mg is also a prescription medication approved for patients with various conditions including Wet AMD and Macular Edema due to Retinal Vein Occlusion (RVO).
Both EYLEA HD and EYLEA are administered via injection into the eye. Patients should not use these medications if they have an infection in or around the eye, are experiencing eye pain or redness, or have known allergies to any component of these medications, including aflibercept.
It is important for patients to be aware that injections can lead to adverse effects such as infections, retinal detachment, and in rare instances, serious inflammation of the retinal blood vessels. Individuals receiving EYLEA HD or EYLEA may also experience a temporary increase in eye pressure. Regular monitoring after injections is advised.
The most frequently reported side effects of EYLEA HD include cataracts, increased eye redness, elevated eye pressure, eye discomfort, and changes in vision. Similar side effects have been reported for EYLEA.
About Regeneron
Founded by physician-scientists, Regeneron (NASDAQ: REGN) is esteemed for its innovative approach to biotechnology, focusing on developing life-transforming medicines for a multitude of serious diseases. The companys unique ability to translate scientific research into tangible treatments has led to numerous FDA-approved therapies and a promising pipeline of candidates under development. Regenerons portfolio aims to address various health conditions including eye diseases, cancer, cardiovascular diseases, and rare genetic disorders.
Utilizing proprietary technologies such as VelociSuite, Regeneron is constantly pushing the boundaries of scientific discovery to enhance drug development. The company also employs insights from the Regeneron Genetics Center to identify new treatment targets and develop cutting-edge therapeutic solutions.
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Erik Nilsson
