EYLEA HD® (aflibercept) Injection 8 mg Positive Phase 3 Results in Patients with Macular Edema following Retinal Vein Occlusion Presented at Angiogenesis Meeting
Regeneron Pharmaceuticals (REGN) presented positive Phase 3 QUASAR trial results for EYLEA HD® (aflibercept) Injection 8 mg in treating macular edema following retinal vein occlusion (RVO). The trial met its primary endpoint, demonstrating that EYLEA HD patients dosed every 8 weeks achieved non-inferior vision gains compared to EYLEA® 2 mg dosed every 4 weeks.
Key findings show that 88% of patients maintained an 8-week dosing schedule after 3 initial monthly doses, and 93% after 5 initial monthly doses. The safety profile remained consistent with previous trials, with ocular pressure increase reported in 5% of patients. The data will support a supplemental Biologics License Application to the FDA in Q1 2025.
Regeneron Pharmaceuticals (REGN) ha presentato risultati positivi della fase 3 della sperimentazione QUASAR per EYLEA HD® (aflibercept) Iniezione 8 mg nel trattamento dell'edema maculare dopo occlusione venosa retinica (RVO). Lo studio ha raggiunto il suo obiettivo primario, dimostrando che i pazienti trattati con EYLEA HD ogni 8 settimane hanno ottenuto guadagni visivi non inferiori rispetto ai pazienti trattati con EYLEA® 2 mg ogni 4 settimane.
I risultati chiave mostrano che l'88% dei pazienti ha mantenuto un programma di dosaggio di 8 settimane dopo 3 dosi mensili iniziali e il 93% dopo 5 dosi mensili iniziali. Il profilo di sicurezza è rimasto coerente con studi precedenti, con un aumento della pressione oculare riportato nel 5% dei pazienti. I dati supporteranno una domanda di licenza biologica supplementare alla FDA nel Q1 2025.
Regeneron Pharmaceuticals (REGN) presentó resultados positivos del ensayo de fase 3 QUASAR para EYLEA HD® (aflibercept) Inyección de 8 mg en el tratamiento del edema macular posterior a la oclusión de la vena retiniana (RVO). El ensayo cumplió su objetivo primario, demostrando que los pacientes de EYLEA HD dosificados cada 8 semanas lograron ganancias visuales no inferiores comparadas con los pacientes de EYLEA® 2 mg dosificados cada 4 semanas.
Los hallazgos clave muestran que el 88% de los pacientes mantuvo un esquema de dosificación de 8 semanas después de 3 dosis mensuales iniciales, y el 93% después de 5 dosis mensuales iniciales. El perfil de seguridad se mantuvo consistente con ensayos previos, con un aumento de la presión ocular reportado en el 5% de los pacientes. Los datos respaldarán una solicitud de modificación de la licencia biológica a la FDA en el primer trimestre de 2025.
레제너론 제약(Regeneron Pharmaceuticals, REGN)은 망막 정맥 폐쇄(RVO)로 인한 황반 부종 치료를 위한 EYLEA HD® (aflibercept) 주사 8 mg에 대한 긍정적인 3상 QUASAR 시험 결과를 발표했습니다. 이 시험은 주요 목표를 달성하여, 8주마다 투여받는 EYLEA HD 환자들이 4주마다 투여받는 EYLEA® 2 mg에 비해 시력 저하 없이 동등한 시력 향상을 보였음을 보여주었습니다.
주요 발견에 따르면, 88%의 환자가 3회 초기 월간 투여 후 8주 투여 일정을 유지했습니다, 그리고 5회 초기 월간 투여 후에는 93%가 유지했습니다. 안전성 프로필은 이전 시험과 일관성을 유지했으며, 5%의 환자에서 안압 증가가 보고되었습니다. 이러한 데이터는 2025년 1분기에 FDA에 대한 보충 생물학적 라이센스 신청을 지원할 것입니다.
Regeneron Pharmaceuticals (REGN) a présenté des résultats positifs de l'essai de phase 3 QUASAR pour EYLEA HD® (aflibercept) Injection 8 mg dans le traitement de l'œdème maculaire suite à une occlusion veineuse rétinienne (RVO). L'essai a atteint son objectif principal, démontrant que les patients EYLEA HD dosés toutes les 8 semaines ont obtenu des gains visuels non inférieurs à ceux des patients EYLEA® 2 mg dosés toutes les 4 semaines.
Les résultats clés montrent que 88 % des patients ont maintenu un schéma de dosage de 8 semaines après 3 doses mensuelles initiales et 93 % après 5 doses mensuelles initiales. Le profil de sécurité est resté cohérent avec les essais précédents, avec une augmentation de la pression oculaire signalée chez 5 % des patients. Les données soutiendront une demande de licence biologique complémentaire auprès de la FDA au premier trimestre 2025.
Regeneron Pharmaceuticals (REGN) hat positive Ergebnisse der Phase-3-Studie QUASAR für EYLEA HD® (Aflibercept) Injektion 8 mg zur Behandlung von Makulaödemen nach retinaler Venenthrombose (RVO) vorgestellt. Die Studie erreichte den primären Endpunkt und zeigte, dass EYLEA HD-Patienten, die alle 8 Wochen behandelt wurden, im Vergleich zu EYLEA® 2 mg, die alle 4 Wochen verabreicht wurden, gleichwertige Sehverbesserungen erzielten.
Wichtige Ergebnisse zeigen, dass 88% der Patienten einen 8-Wochen-Dosierungsplan beibehielten nach 3 anfänglichen monatlichen Dosen und 93% nach 5 anfänglichen monatlichen Dosen. Das Sicherheitsprofil blieb konsistent mit früheren Studien, wobei ein Anstieg des Augeninnendrucks in 5% der Patienten berichtet wurde. Diese Daten werden einen unterstützenden Antrag auf eine ergänzende biologische Lizenz bei der FDA im ersten Quartal 2025 unterstützen.
- Phase 3 QUASAR trial met primary endpoint showing non-inferior efficacy with half the injections
- High patient retention rate on 8-week dosing schedule (88-93%)
- Safety profile consistent with previous trials
- Potential FDA submission in Q1 2025
- Reported cases of endophthalmitis and retinal vasculitis
- 5% of patients experienced increased ocular pressure
Insights
The Phase 3 QUASAR trial results for EYLEA HD represent a significant advancement in RVO treatment, potentially transforming the standard of care in the
Key strategic implications include:
- The reduced treatment burden (8-week vs. 4-week dosing) with equivalent efficacy provides a compelling competitive advantage in the anti-VEGF market
- High patient retention rates (
88% and93% ) on extended dosing suggests strong real-world adoption potential - Safety profile consistency minimizes regulatory hurdles for the upcoming FDA submission
- The timing of Q1 2025 submission positions EYLEA HD for potential approval by early 2026
For Regeneron's business outlook, this development strengthens their ophthalmology franchise against emerging biosimilar competition. The Bayer partnership for ex-U.S. markets ensures global market penetration while maintaining profitable revenue sharing arrangements. The successful trial results should support premium pricing strategies and help defend market share in the competitive retinal disease space.
EYLEA HD led to improved vision with extended dosing intervals, achieving non-inferior vision gains with an every 8-week dosing regimen compared to EYLEA® (aflibercept) Injection 2 mg dosed every 4 weeks
TARRYTOWN, N.Y., Feb. 08, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced the first presentation of positive results from the Phase 3 QUASAR trial investigating EYLEA HD® (aflibercept) Injection 8 mg for the treatment of patients with macular edema following retinal vein occlusion (RVO), including those with central, branch and hemiretinal vein occlusions. The data were presented today at the virtual Angiogenesis (Angiogenesis, Exudation, and Degeneration) 2025 annual meeting and will support the submission of a supplemental Biologics License Application to the U.S. Food and Drug Administration (FDA) in the first quarter of 2025.
“Retinal vein occlusion is the second most common retinal vascular disease. However, the current treatment paradigm of monthly eye injections can make it challenging for patients to maintain their treatment plan, potentially leading to poor adherence and vision loss,” said Seenu M. Hariprasad, M.D., Chair of the Department of Ophthalmology and Visual Science, The University of Chicago. “Based on these new data, aflibercept 8 mg may offer the potential to halve the number of injections needed, as compared to standard-of-care aflibercept 2 mg and other anti-VEGF therapies.”
As presented at Angiogenesis, the QUASAR trial met its primary endpoint at 36 weeks, with both groups of EYLEA HD patients dosed every 8 weeks achieving non-inferior visual acuity gains compared to those receiving EYLEA® (aflibercept) Injection 2 mg dosed every 4 weeks. The EYLEA HD results were consistent across patients with branch retinal vein occlusions, and those with central retinal or hemiretinal vein occlusions. Furthermore, in patients treated with EYLEA HD through 36 weeks,
The safety profile of EYLEA HD (n=591) was similar to EYLEA (n=301) in QUASAR and remained generally consistent with the known safety profile of EYLEA HD in its pivotal trials. Ocular treatment-emergent adverse events (TEAEs) occurring in ≥
Data from QUASAR were first shared in December 2024.
EYLEA HD (known as Eylea™ 8 mg in the European Union and Japan) is being jointly developed by Regeneron and Bayer AG. In the U.S., Regeneron maintains exclusive rights to EYLEA and EYLEA HD. Bayer has licensed the exclusive marketing rights outside of the U.S., where the companies share equally the profits from sales of EYLEA and EYLEA HD.
The safety and efficacy of EYLEA HD for the treatment of RVO has not been evaluated by any regulatory authority.
About the QUASAR Trial
QUASAR is a global double-masked, active-controlled Phase 3 trial evaluating the efficacy and safety of EYLEA HD in patients with macular edema secondary to RVO, including those with central retinal vein occlusion, branch retinal vein occlusion, or hemiretinal vein occlusion.
In the trial, patients were randomized into three groups to receive either: EYLEA HD every 8 weeks following 3 initial monthly doses; EYLEA HD every 8 weeks following 5 initial monthly doses; or EYLEA every 4 weeks. The primary endpoint was mean change in BCVA from randomization through week 36, as measured by the Early Treatment Diabetic Retinopathy Study letter score.
Patients in the EYLEA HD groups can have their dosing intervals shortened to a minimum of every 4 weeks throughout the trial if protocol-defined criteria for disease progression are met. Dosing intervals may be extended based on protocol-defined criteria starting at week 32 for patients who receive EYLEA or EYLEA HD after 3 initial monthly doses or at week 40 for patients who receive EYLEA HD after 5 initial monthly doses, with follow-up planned through week 64.
QUASAR is being operationalized by Bayer under a collaboration agreement with Regeneron.
About Retinal Vein Occlusion
RVO is a common cause of vision loss in adults and the second most common retinal vascular disease. RVO occurs when there is a blockage in a vein in the retina, which leads to a buildup of blood, restricted blood flow, increased pressure and sometimes pain in the eye. RVO may cause sudden blurry vision or vision loss and can ultimately result in serious complications like swelling in the eye called macular edema.
A protein called vascular endothelial growth factor (VEGF) is instrumental in causing the vascular leakage that leads to macular edema. When a vein in the retina is blocked, the levels of VEGF increase, which spurs new blood vessel growth. Too much VEGF can lead to the formation of abnormal blood vessels and may cause vision to become blurry. Anti-VEGF injections are commonly used to treat macular edema due to RVO.
There are two main types of RVO: central retinal vein occlusion (CRVO) and branch retinal vein occlusion (BRVO). In CRVO, the buildup occurs in the eye’s central retinal vein and in BRVO, the buildup occurs in one of the smaller branch veins. Globally, RVO affects over 28 million people.
IMPORTANT SAFETY INFORMATION AND INDICATIONS
INDICATIONS
EYLEA HD® (aflibercept) Injection 8 mg is a prescription medicine approved for the treatment of patients with Wet Age-Related Macular Degeneration (AMD), Diabetic Macular Edema (DME), and Diabetic Retinopathy (DR).
EYLEA® (aflibercept) Injection 2 mg is a prescription medicine approved for the treatment of patients with Wet Age-Related Macular Degeneration (AMD), Macular Edema following Retinal Vein Occlusion (RVO), Diabetic Macular Edema (DME), Diabetic Retinopathy (DR), and Retinopathy of Prematurity (ROP) (0.4 mg).
IMPORTANT SAFETY INFORMATION
- EYLEA HD and EYLEA are administered by injection into the eye. You should not use EYLEA HD or EYLEA if you have an infection in or around the eye, eye pain or redness, or known allergies to any of the ingredients in EYLEA HD or EYLEA, including aflibercept.
- Injections into the eye with EYLEA HD or EYLEA can result in an infection in the eye, retinal detachment (separation of retina from back of the eye) and, more rarely, serious inflammation of blood vessels in the retina that may include blockage. Call your doctor right away if you or your baby (if being treated with EYLEA for Retinopathy of Prematurity) experience eye pain or redness, light sensitivity, or a change in vision after an injection.
- In some patients, injections with EYLEA HD or EYLEA may cause a temporary increase in eye pressure within 1 hour of the injection. Sustained increases in eye pressure have been reported with repeated injections, and your doctor may monitor this after each injection.
- In infants with Retinopathy of Prematurity (ROP), treatment with EYLEA will need extended periods of ROP monitoring.
- There is a potential but rare risk of serious and sometimes fatal side effects, related to blood clots, leading to heart attack or stroke in patients receiving EYLEA HD or EYLEA.
- The most common side effects reported in patients receiving EYLEA HD were cataract, increased redness in the eye, increased pressure in the eye, eye discomfort, pain, or irritation, blurred vision, vitreous (gel-like substance) floaters, vitreous detachment, injury to the outer layer of the eye, and bleeding in the back of the eye.
- The most common side effects reported in patients receiving EYLEA were increased redness in the eye, eye pain, cataract, vitreous detachment, vitreous floaters, moving spots in the field of vision, and increased pressure in the eye.
- The most common side effects reported in pre-term infants with ROP receiving EYLEA were separation of the retina from the back of the eye, increased redness in the eye, and increased pressure in the eye. Side effects that occurred in adults are considered applicable to pre-term infants with ROP, though not all were seen in clinical studies.
- You may experience temporary visual changes after an EYLEA HD or EYLEA injection and associated eye exams; do not drive or use machinery until your vision recovers sufficiently.
- For additional safety information, please talk to your doctor and see the full Prescribing Information for EYLEA HD and EYLEA.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Please click here for full Prescribing Information for EYLEA HD and EYLEA.
About Regeneron
Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents, develops and commercializes life-transforming medicines for people with serious diseases. Founded and led by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to numerous approved treatments and product candidates in development, most of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurological diseases, hematologic conditions, infectious diseases, and rare diseases.
Regeneron pushes the boundaries of scientific discovery and accelerates drug development using our proprietary technologies, such as VelociSuite®, which produces optimized fully human antibodies and new classes of bispecific antibodies. We are shaping the next frontier of medicine with data-powered insights from the Regeneron Genetics Center® and pioneering genetic medicine platforms, enabling us to identify innovative targets and complementary approaches to potentially treat or cure diseases.
For more information, please visit www.Regeneron.com or follow Regeneron on LinkedIn, Instagram, Facebook or X.
Forward-Looking Statements and Use of Digital Media
This press release includes forward-looking statements that involve risks and uncertainties relating to future events and the future performance of Regeneron Pharmaceuticals, Inc. (“Regeneron” or the “Company”), and actual events or results may differ materially from these forward-looking statements. Words such as “anticipate,” “expect,” “intend,” “plan,” “believe,” “seek,” “estimate,” variations of such words, and similar expressions are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. These statements concern, and these risks and uncertainties include, among others, the nature, timing, and possible success and therapeutic applications of products marketed or otherwise commercialized by Regeneron and/or its collaborators or licensees (collectively, “Regeneron’s Products”) and product candidates being developed by Regeneron and/or its collaborators or licensees (collectively, “Regeneron’s Product Candidates”) and research and clinical programs now underway or planned, including without limitation EYLEA HD® (aflibercept) Injection 8 mg; the likelihood, timing, and scope of possible regulatory approval and commercial launch of Regeneron’s Product Candidates and new indications for Regeneron’s Products, such as EYLEA HD for the treatment of patients with macular edema following retinal vein occlusion (“RVO”); uncertainty of the utilization, market acceptance, and commercial success of Regeneron’s Products and Regeneron’s Product Candidates and the impact of studies (whether conducted by Regeneron or others and whether mandated or voluntary), including the studies discussed or referenced in this press release, on any of the foregoing or any potential regulatory approval of Regeneron’s Products (such as EYLEA HD for the treatment of patients with RVO) and Regeneron’s Product Candidates; the ability of Regeneron’s collaborators, licensees, suppliers, or other third parties (as applicable) to perform manufacturing, filling, finishing, packaging, labeling, distribution, and other steps related to Regeneron’s Products and Regeneron’s Product Candidates; the ability of Regeneron to manage supply chains for multiple products and product candidates; safety issues resulting from the administration of Regeneron’s Products (such as EYLEA HD) and Regeneron’s Product Candidates in patients, including serious complications or side effects in connection with the use of Regeneron’s Products and Regeneron’s Product Candidates in clinical trials; determinations by regulatory and administrative governmental authorities which may delay or restrict Regeneron’s ability to continue to develop or commercialize Regeneron’s Products and Regeneron’s Product Candidates; ongoing regulatory obligations and oversight impacting Regeneron’s Products, research and clinical programs, and business, including those relating to patient privacy; the availability and extent of reimbursement of Regeneron’s Products from third-party payers, including private payer healthcare and insurance programs, health maintenance organizations, pharmacy benefit management companies, and government programs such as Medicare and Medicaid; coverage and reimbursement determinations by such payers and new policies and procedures adopted by such payers; changes in laws, regulations, and policies affecting the healthcare industry; competing drugs and product candidates that may be superior to, or more cost effective than, Regeneron’s Products and Regeneron’s Product Candidates (including biosimilar versions of Regeneron’s Products); the extent to which the results from the research and development programs conducted by Regeneron and/or its collaborators or licensees may be replicated in other studies and/or lead to advancement of product candidates to clinical trials, therapeutic applications, or regulatory approval; unanticipated expenses; the costs of developing, producing, and selling products; the ability of Regeneron to meet any of its financial projections or guidance and changes to the assumptions underlying those projections or guidance; the potential for any license, collaboration, or supply agreement, including Regeneron’s agreements with Sanofi and Bayer (or their respective affiliated companies, as applicable), to be cancelled or terminated; the impact of public health outbreaks, epidemics, or pandemics on Regeneron's business; and risks associated with litigation and other proceedings and government investigations relating to the Company and/or its operations (including the pending civil proceedings initiated or joined by the U.S. Department of Justice and the U.S. Attorney's Office for the District of Massachusetts), risks associated with intellectual property of other parties and pending or future litigation relating thereto (including without limitation the patent litigation and other related proceedings relating to EYLEA® (aflibercept) Injection 2 mg), the ultimate outcome of any such proceedings and investigations, and the impact any of the foregoing may have on Regeneron’s business, prospects, operating results, and financial condition. A more complete description of these and other material risks can be found in Regeneron’s filings with the U.S. Securities and Exchange Commission, including its Form 10-K for the year ended December 31, 2024. Any forward-looking statements are made based on management’s current beliefs and judgment, and the reader is cautioned not to rely on any forward-looking statements made by Regeneron. Regeneron does not undertake any obligation to update (publicly or otherwise) any forward-looking statement, including without limitation any financial projection or guidance, whether as a result of new information, future events, or otherwise.
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FAQ
What were the key results of REGN's Phase 3 QUASAR trial for EYLEA HD?
How many patients maintained the 8-week dosing schedule with EYLEA HD in the QUASAR trial?
What are the main safety concerns identified in the EYLEA HD QUASAR trial?
When will Regeneron submit EYLEA HD for FDA approval for RVO treatment?
