EYLEA® HD (aflibercept) Injection 8 mg Pivotal Data in Wet Age-related Macular Degeneration (wAMD) and Diabetic Macular Edema (DME) Published in The Lancet
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Insights
The recent publication of the PULSAR and PHOTON trials in The Lancet concerning EYLEA HD (aflibercept) Injection 8 mg is a significant development in the treatment of wAMD and DME. The non-inferiority of EYLEA HD to the standard EYLEA treatment is particularly noteworthy as it suggests that patients could maintain visual acuity gains with less frequent dosing. This could lead to a paradigm shift in patient care, emphasizing convenience and potentially improving adherence to treatment protocols. The extended 12- or 16-week dosing regimens could also alleviate the treatment burden on healthcare systems by reducing the frequency of patient visits and injections, which may translate into cost savings for both providers and patients.
It is crucial to monitor the long-term efficacy and safety of EYLEA HD, especially given the chronic nature of wAMD and DME. The two-year data presented at recent congresses will be key in understanding the sustained impact of this treatment. Furthermore, the shared profit model between Regeneron and Bayer AG in markets outside the U.S. could influence the global distribution and marketing strategies for EYLEA HD, potentially affecting its market penetration and competitive dynamics within the ophthalmology sector.
The approval of EYLEA HD and its subsequent adoption could have significant economic implications for the healthcare sector. By increasing the interval between doses, there is potential for reduced clinical workload and associated healthcare costs. However, the cost-effectiveness of EYLEA HD compared to its predecessor will be a critical factor in its uptake. Payers, including insurance companies and government health programs, will likely scrutinize the pricing of EYLEA HD in relation to its clinical benefits and the potential for overall savings. If deemed cost-effective, EYLEA HD could see rapid adoption, which would impact Regeneron's revenue and market share.
From an economic perspective, the most common adverse reactions associated with EYLEA HD, while comparable to the original EYLEA, should also be considered in the overall cost analysis. Adverse events can lead to additional treatments and costs and their prevalence will be a factor in the long-term economic assessment of the drug's value proposition.
The strategic collaboration between Regeneron and Bayer AG for the development and marketing of EYLEA HD presents an interesting case for market dynamics. The exclusive marketing rights outside the U.S. by Bayer could influence how EYLEA HD is positioned against competitors in the international arena. Additionally, the approval of Eylea 8 mg in the European Union, Japan and other countries, with ongoing submissions to other regulatory authorities, suggests an aggressive expansion strategy that could disrupt existing market equilibriums.
The stock market often reacts to pharmaceutical advancements and regulatory approvals and the approval of EYLEA HD in multiple jurisdictions, coupled with positive clinical trial results, could be a catalyst for investor interest in Regeneron Pharmaceuticals. The long-term market impact will hinge on the drug's commercial success, competition and ability to sustain its clinical efficacy and safety profile over time.
Published results show EYLEA HD with extended 12- or 16-week dosing regimens demonstrated non-inferior vision gains to standard of care EYLEA® (aflibercept) Injection 2 mg with fixed 8-week dosing in patients with wAMD and DME in the first year
EYLEA HD has shown impressive durable visual improvements and rapid and resilient fluid control with a safety profile comparable to EYLEA
Extended dosing intervals with EYLEA HD have the potential to substantially reduce treatment burden for patients
EYLEA HD has been approved in multiple countries including the U.S., EU and Japan
TARRYTOWN, N.Y., March 08, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced The Lancet published one-year results from the pivotal PULSAR and PHOTON trials for EYLEA® HD (aflibercept) Injection 8 mg. Specifically, the publications detailed data demonstrating that EYLEA HD extended dosing regimens were non-inferior to EYLEA® (aflibercept) Injection 2 mg for both the treatment of wet age-related macular degeneration (wAMD) and diabetic macular edema (DME).
“The publication of 48-week results from PULSAR and PHOTON in The Lancet are a recognition of the important advancement EYLEA HD has made in retinal care,” said David M. Brown, M.D., FACS, Director of Research at Retina Consultants of Texas and a trial investigator. “Less than a year after its approval, EYLEA HD has already made an impact in the treatment of wet age-related macular degeneration and diabetic macular edema. EYLEA HD has provided disease control for my tough-to-treat cases of diabetic eye disease and allowed both my diabetic and wet age-related macular degeneration patients to enjoy less frequent dosing with a similar safety profile to EYLEA.”
PULSAR and PHOTON are two double-masked, active-controlled pivotal trials evaluating EYLEA HD compared to EYLEA. As published in The Lancet, both PULSAR in wAMD (N=1,009) and PHOTON in DME (N=658) met their primary endpoints, with EYLEA HD demonstrating non-inferior and clinically equivalent vision gains at 48 weeks with both 12- and 16-week dosing regimens after only 3 initial monthly doses, compared to an EYLEA 8-week dosing regimen after initial monthly doses (3 in PULSAR and 5 in PHOTON). Furthermore,
The most common adverse reactions (≥
In August 2023, EYLEA HD was approved by the U.S. Food and Drug Administration for the treatment of patients with wAMD, DME and diabetic retinopathy (DR) based on the one-year data. Two-year data were presented in 2023 for PULSAR at the EURETINA Congress and for PHOTON at the American Society of Retina Specialists annual meeting.
EYLEA HD 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 (known as Eylea 8 mg outside the U.S.). Eylea 8 mg is approved in the European Union, Japan and other countries. Submissions to other regulatory authorities in additional countries have been made.
About the EYLEA HD Clinical Trial Program
PULSAR in wAMD and PHOTON in DME are double-masked, active-controlled pivotal trials that are being conducted in multiple centers globally. In both trials, patients were randomized into 3 treatment groups to receive either: EYLEA HD every 12 weeks, EYLEA HD every 16 weeks, or EYLEA every 8 weeks. The lead sponsors of the trials were Bayer for PULSAR and Regeneron for PHOTON.
Patients treated with EYLEA HD in both trials had 3 initial monthly doses, and patients treated with EYLEA received 3 initial doses in PULSAR and 5 in PHOTON. In the first year, patients in the EYLEA HD groups could have their dosing intervals shortened down to an every 8-week interval if protocol-defined criteria for disease progression were observed. Intervals could not be extended until the second year of the study. Patients in all EYLEA groups maintained a fixed 8-week dosing regimen throughout their participation in the trials.
About wAMD and Diabetic Eye Disease
wAMD is a retinal disease that may affect people as they age. It occurs when abnormal blood vessels grow and leak fluid under the macula, the part of the eye responsible for sharp central vision and seeing fine detail. This fluid can damage and scar the macula, which can cause vision loss. An estimated 1.4 million Americans have wAMD.
DR is an eye disease characterized by microvascular damage to the blood vessels in the retina often caused by poor blood sugar control in people with diabetes. The disease generally starts as nonproliferative diabetic retinopathy (NPDR) and often has no warning signs or symptoms. NPDR may progress to proliferative diabetic retinopathy (PDR), a stage of the disease in which abnormal blood vessels grow onto the surface of the retina and into the vitreous cavity, potentially causing severe vision loss.
DME can occur at any stage of DR as the blood vessels in the retina become increasingly fragile and leak fluid, potentially causing visual impairment. In the U.S., approximately 1.5 million adults are diagnosed with DME, while approximately 6 million people have DR without DME.
About Ophthalmology at Regeneron
At Regeneron, we relentlessly pursue groundbreaking innovations in eye care science to help maintain the eye health of the millions of Americans impacted by vision-threatening conditions. Over a decade ago, our breakthrough scientific research resulted in the development of EYLEA, a vascular endothelial growth factor (VEGF) inhibitor designed to block the growth of new blood vessels and decrease the ability of fluid to pass through blood vessels in the eye. EYLEA has since brought fundamental change to the retinal disease treatment landscape and is supported by a robust body of research that includes eight pivotal Phase 3 trials, 11 years of real-world experience, and more than 70 million EYLEA injections globally.
Regeneron continues to advance our anti-angiogenesis expertise with new solutions with the aim of offering optimal flexibility for a broad group of patients and eye care professionals. This includes EYLEA HD, which has been developed with the aim of extending the time between injections, while maintaining the vision gains, anatomic benefits and safety previously observed with EYLEA.
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 for over 35 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to numerous FDA-approved treatments and product candidates in development, almost all 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, hematologic conditions, infectious diseases and rare diseases.
Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite® technologies, such as VelocImmune®, which uses unique genetically humanized mice to produce optimized fully human antibodies and bispecific antibodies, and through ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world.
For more information, please visit www.Regeneron.com or follow Regeneron on LinkedIn.
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. 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FAQ
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