TARRYTOWN, N.Y., April 2, 2026
Regeneron Pharmaceuticals, Inc. has announced that the U.S. Food and Drug Administration (FDA) has approved an expanded dosing regimen for EYLEA HD® (aflibercept), making it the first and only injectable anti-VEGF therapy with dosing intervals of up to 5 months for patients with wet age-related macular degeneration (wAMD) and diabetic macular edema (DME). This landmark approval is based on robust 96-week clinical trial data, demonstrating that patients can maintain visual and anatomical improvements with significantly reduced treatment frequency, marking a major advancement in retinal disease management and patient care.
Extended Dosing Reduces Treatment Burden for Patients
The updated FDA approval allows eligible patients who respond well to initial therapy to receive EYLEA HD injections as infrequently as every 20 weeks, potentially reducing treatment to just 2–3 injections per year, compared to more frequent dosing schedules required with earlier therapies. This extended interval represents a significant improvement in patient compliance, convenience, and quality of life, particularly for individuals requiring long-term management of chronic eye diseases.
The approval further expands the flexibility of dosing, allowing physicians to tailor treatment intervals based on individual patient response, ranging from monthly dosing to extended intervals of up to five months. This adaptability reinforces EYLEA HD’s position as a leading anti-VEGF therapy with unmatched dosing versatility in ophthalmology.
Clinical Trials Demonstrate Sustained Efficacy and Safety
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The FDA decision is supported by results from the pivotal Phase III PULSAR (wAMD) and PHOTON (DME) trials, which evaluated the efficacy and safety of EYLEA HD over a 96-week period. Data showed that a majority of patients maintained consistent visual acuity and anatomical outcomes, even with extended dosing intervals. Specifically, up to 71% of wAMD patients and 72% of DME patients achieved dosing intervals of 16 weeks or longer, while a significant proportion reached 20-week intervals without compromising treatment efficacy.
Importantly, the safety profile remained consistent with previously established anti-VEGF therapies, with no new safety concerns identified. These findings underscore the therapy’s ability to deliver long-term disease control with fewer injections, addressing a critical challenge in ophthalmology treatment adherence.
Advancing Innovation in Ophthalmology and Retinal Care
Wet age-related macular degeneration and diabetic macular edema are leading causes of vision loss worldwide, driven by abnormal blood vessel growth and fluid leakage in the retina. Traditional anti-VEGF therapies require frequent intravitreal injections, placing a significant burden on both patients and healthcare systems. The development of EYLEA HD, a higher-dose formulation of aflibercept, represents a next-generation innovation designed to maintain efficacy while reducing injection frequency.
This advancement not only enhances patient adherence and long-term outcomes, but also reflects a broader industry trend toward durable therapies that optimize treatment efficiency. Regeneron’s continued leadership in angiogenesis research and ophthalmology innovation further strengthens its position in delivering transformative therapies for vision-threatening diseases.
With this approval, Regeneron sets a new benchmark in retinal disease treatment, offering a clinically validated, long-acting anti-VEGF therapy that significantly reduces treatment burden while maintaining high standards of efficacy and safety, ultimately improving outcomes for patients living with chronic vision disorders.
Source: Regeneron press release
