TARRYTOWN, N.Y., April 17, 2025 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) has made a significant announcement that could reshape the treatment landscape for retinal vein occlusion (RVO). The U.S. Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for EYLEA HD (aflibercept) Injection 8 mg. This application seeks approval for two pivotal advancements: the treatment of macular edema following RVO and an extension of the dosing regimen to allow for administration every eight weeks after an initial monthly dosing period. If approved, this would effectively halve the number of injections currently required by existing anti-VEGF therapies, providing substantial benefits to both patients and healthcare providers.

The FDA has set a target action date of August 19, 2025, for a decision regarding this application, following the use of a Priority Review voucher. This expedited review process underscores the potential impact of EYLEA HD in improving clinical outcomes for patients suffering from this condition.

The clinical evidence supporting the sBLA is robust, stemming from comprehensive data accumulated throughout the EYLEA HD clinical program, notably the Phase 3 QUASAR trial. This trial specifically focused on EYLEA HDs efficacy in treating RVO. Preliminary results indicate that patients receiving EYLEA HD dosed every eight weeks after either three or five initial monthly doses achieved visual acuity gains comparable to those of patients treated with EYLEA (aflibercept) Injection 2 mg administered every four weeks. Notably, this represents a significant advancement in patient care, as current anti-VEGF therapies are strictly administered on a monthly basis.

In terms of safety, the QUASAR trial reported a safety profile for EYLEA HD that aligns closely with that of EYLEA. Among the 591 participants in the EYLEA HD group, only 5% experienced increased ocular pressure, compared to 1.7% in the EYLEA group. Additionally, there were isolated cases of endophthalmitis and retinal vasculitis, with EYLEA HD reporting one case of each, while EYLEA had two cases of endophthalmitis but none of retinal vasculitis. Significantly, no instances of occlusive retinal vasculitis were reported, indicating a favorable safety profile for EYLEA HD.

It is critical to note, however, that the FDA has yet to evaluate the safety and efficacy of EYLEA HD specifically for the treatment of RVO and its proposed monthly dosing schedule.

About the QUASAR Trial

The QUASAR trial is a global, double-masked, active-controlled Phase 3 study that assesses the efficacy and safety of EYLEA HD in patients diagnosed with macular edema due to RVO. Participants were randomized into three distinct groups: one group received EYLEA HD every eight weeks after three initial monthly doses, another group received it after five monthly doses, and the control group was administered EYLEA every four weeks. The primary endpoint focused on the mean change in best corrected visual acuity (BCVA) from the outset through week 36, utilizing the Early Treatment Diabetic Retinopathy Study letter score as the measurement standard.

The QUASAR trial is being conducted under a collaboration agreement with Bayer, highlighting the ongoing partnership between the two companies in advancing ophthalmic therapies.

Understanding Retinal Vein Occlusion

RVO is a prevalent cause of vision loss in adults and ranks as the second most common retinal vascular disease. It arises from a blockage in a vein in the retina, leading to blood accumulation, restricted blood flow, elevated pressure, and potential ocular pain. Symptoms can include sudden blurry vision or vision loss, and the condition can result in severe complications, such as macular edema.

The underlying mechanism involves a protein known as vascular endothelial growth factor (VEGF), which is critical in causing vascular leakage and subsequent macular edema. When retinal veins become blocked, VEGF levels increase, prompting the growth of new blood vessels. An excess of VEGF can lead to the formation of abnormal vessels, contributing to visual impairment. Anti-VEGF injections are a common therapeutic approach for treating macular edema secondary to RVO.

RVO is classified into two main types: central retinal vein occlusion (CRVO), where blockage occurs in the central vein of the retina, and branch retinal vein occlusion (BRVO), which affects one of the smaller branch veins. Globally, RVO impacts over 28 million individuals, underscoring the urgent need for effective treatment options.

About EYLEA HD

Regeneron first introduced EYLEA over a decade ago, revolutionizing the treatment paradigm for serious chorioretinal vascular diseases. With a well-documented efficacy and consistent safety profile established through 16 pivotal trials, EYLEA is approved for various vision-threatening conditions, including retinopathy of prematurity (ROP), diabetic macular edema (DME), diabetic retinopathy (DR), macular edema following RVO, and wet age-related macular degeneration (wAMD).

EYLEA HD was developed with the goal of offering comparable efficacy and safety to EYLEA while reducing the frequency of injections required. Currently, EYLEA HD is approved in the U.S. to treat patients with wAMD, DME, and DR.

In terms of global development, EYLEA HD is being co-developed by Regeneron and Bayer AG. Regeneron retains exclusive rights to EYLEA and EYLEA HD within the U.S., while Bayer holds the exclusive marketing rights internationally, with both companies sharing profits equally from sales of these medications.

Regeneron's Commitment to Ophthalmology

Regeneron is dedicated to pioneering advancements in eye care, driven by its commitment to improving the health of millions affected by vision-threatening conditions. The company's deep understanding of angiogenesis and extensive research underpins its ambition to innovate new solutions for patients. The ophthalmology development program at Regeneron includes ongoing efforts to address additional serious eye diseases, such as geographic atrophy (currently undergoing the Phase 3 SIENNA clinical trial), glaucoma, and certain inherited retinal diseases.

Important Safety Information for EYLEA HD

EYLEA HD (aflibercept) Injection 8 mg is a prescription medication approved for treating patients with Wet Age-Related Macular Degeneration (AMD), Diabetic Macular Edema (DME), and Diabetic Retinopathy (DR). It is crucial for patients to be aware of potential side effects associated with EYLEA HD and EYLEA, including serious complications from injections, such as infections and retinal detachment.

Common side effects reported with EYLEA HD include cataracts, increased redness in the eye, and temporary visual changes. Given the potential for serious adverse effects, patients should be encouraged to report any negative side effects to the FDA.

About Regeneron

Founded and led by physician-scientists, Regeneron (NASDAQ: REGN) is a leading biotechnology company focused on inventing, developing, and commercializing transformative medicines for individuals with serious diseases. With a commitment to scientific discovery and accelerating drug development, Regeneron has pioneered innovative therapies across various medical fields, including ophthalmology, oncology, and rare diseases. The company leverages its proprietary technologies to create optimized human antibodies and bispecific antibodies, positioning itself at the forefront of modern medicine.

For more information about Regeneron and its ongoing work, please visit

Hans Schneider