Regeneron Gains FDA Priority Review for EYLEA HD Injection

FDA Priority Review for EYLEA HD Injection

If approved, EYLEA HD would serve as a groundbreaking treatment option for retinal vein occlusion (RVO), allowing for up to an 8-week injection schedule following an initial monthly dosing period. This innovative approach could significantly reduce the number of required injections compared to existing anti-VEGF therapies.

The flexibility of potential monthly dosing across approved indications could be invaluable for both healthcare providers and patients alike, leading to improved treatment adherence.

TARRYTOWN, N.Y. — Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) has announced that the U.S. Food and Drug Administration (FDA) accepted the supplemental Biologics License Application (sBLA) for EYLEA HD (aflibercept) Injection 8 mg for Priority Review. This application aims to secure approval for EYLEA HD as a treatment for macular edema following RVO while expanding the dosing regimen to allow for every 4-week (monthly) administration across its approved indications. The FDA will set a target action date for the end of the approval process.

Data supporting this application comes from the comprehensive clinical program for EYLEA HD, prominently featuring the Phase 3 QUASAR trial focused on RVO treatment. The QUASAR trial met its primary endpoint at 36 weeks, demonstrating that patients receiving EYLEA HD every 8 weeks showed non-inferior improvements in visual acuity compared to those treated with EYLEA at the standard monthly interval.

In terms of safety, the QUASAR trial reported comparable profiles between EYLEA HD (n=591) and EYLEA (n=301). Increases in ocular pressure, a common adverse effect, were observed in 5% of EYLEA HD patients, while the occurrence of other serious complications such as endophthalmitis and retinal vasculitis remained rare.

Understanding the QUASAR Trial

The QUASAR trial is a pivotal Phase 3 study designed to evaluate both the safety and efficacy of EYLEA HD for treating macular edema associated with RVO. Participants were segmented into three groups: one receiving EYLEA HD every 8 weeks after an initial series of monthly doses, another following a more intensive 5-month regimen, and a control group treated with EYLEA every 4 weeks. This study illuminates the promising potential for EYLEA HD’s visual acuity benefits.

Operational efforts for QUASAR are being managed by Bayer in collaboration with Regeneron, reinforcing the cooperative nature of groundbreaking medical research.

Retinal Vein Occlusion and Its Impact

RVO is a prevalent issue leading to significant vision impairment among adults and stands as the second most common retinal vascular disorder. It occurs when a retinal vein experiences blockage, resulting in blood accumulation, increased ocular pressure, and sometimes causing painful symptoms. Affected individuals may suddenly experience blurred vision or loss of sight, which can progressively worsen, leading to severe complications like macular edema.

The role of vascular endothelial growth factor (VEGF) is central to this condition, as elevated VEGF levels lead to vascular leakage and subsequent complications. Anti-VEGF therapies, including EYLEA, have become the standard treatment for managing macular edema due to RVO.

Types of RVO include central retinal vein occlusion (CRVO) and branch retinal vein occlusion (BRVO). The global prevalence of RVO exceeds 28 million individuals, indicating a significant need for improved treatment options.

The Development and Future of EYLEA HD

Over the past decade, Regeneron has transformed the landscape with EYLEA, a powerful vascular endothelial growth factor inhibitor. With a proven efficacy and safety profile from extensive clinical trials, EYLEA is currently authorized to manage a range of severe chorioretinal vascular ailments, from retinopathy of prematurity to diabetic conditions and age-related macular degeneration.

EYLEA HD is designed to offer similar efficacy and safety to EYLEA but with a more patient-centered approach, requiring fewer injections. Approved for use in the U.S. for conditions including wet AMD, diabetic macular edema, and diabetic retinopathy, EYLEA HD is a testament to the ongoing commitment to addressing critical health care needs.

Jointly developed by Regeneron and Bayer AG, EYLEA HD symbolizes a collaborative effort to push the boundaries of eye care. Regeneron retains exclusive U.S. marketing rights, while Bayer manages promotional activities outside the U.S., equally sharing sales profits.

Ophthalmology Development at Regeneron

Regeneron’s ophthalmology division focuses intensely on pioneering research to enhance eye health for millions facing vision-threatening conditions. With an established foundation in angiogenesis research, the company remains dedicated to advancing solutions for diverse eye diseases, including glaucoma and geographic atrophy.

As Regeneron forges ahead in this field, it seeks to leverage its scientific insights and innovative platforms to tackle not only prevalent but also inherited retinal diseases.

Frequently Asked Questions

What is EYLEA HD?

EYLEA HD is a prescription medication designed for the treatment of RVO and other conditions like wet AMD, offering patients reduced injection frequency.

What does FDA Priority Review mean?

FDA Priority Review signifies that a drug application is expected to potentially provide significant advantages over existing therapies.

How does EYLEA HD differ from standard EYLEA?

EYLEA HD offers the same efficacy as standard EYLEA but with a reduced number of required injections, promoting patient convenience.

What side effects are associated with EYLEA HD?

Common side effects include increased ocular pressure, redness, and discomfort in the eye, though serious side effects are rare.

What ongoing studies are related to EYLEA HD?

Ongoing studies include the QUASAR trial, which focuses on the effectiveness and safety of EYLEA HD for RVO patients.

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