EYLEA® HD (aflibercept) Injection 8 mg Data Presentations at AAO Reinforce Efficacy and Safety Profile in Wet Age-related Macular Degeneration and Diabetic Macular Edema
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Long-term data and subgroup analyses from pivotal EYLEA HD clinical program highlight durability of visual improvements and consistent safety across extended dosing intervals and patient characteristics
TARRYTOWN, N.Y., Nov. 01, 2023 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced long-term outcomes and new analyses of pivotal clinical data for EYLEA® HD (aflibercept) Injection 8 mg will be presented at the American Academy of Ophthalmology (AAO) annual meeting in San Francisco from November 3 to 6.
“Following the approval of EYLEA HD, we have continued to evaluate data from the pivotal clinical program to identify new insights that may support physicians in administering this innovative treatment to patients living with certain serious retinal diseases,” said Boaz Hirshberg, M.D., Senior Vice President, Clinical Development, Internal Medicine at Regeneron. “At this year’s AAO, we will present a wide-ranging review of results from the PULSAR and PHOTON trials in wet age-related macular degeneration and diabetic macular edema. Together, they showcase the impressive durability and consistent safety profile of EYLEA HD over the long-term across different extended dosing intervals and patient characteristics.”
Notable presentations include a detailed review of positive two-year (96 weeks) results from the pivotal PULSAR and PHOTON trials investigating EYLEA HD with 12- and 16-week dosing regimens, compared to EYLEA® (aflibercept) Injection 8-week dosing regimens, in patients with wet age-related macular degeneration (wAMD) and diabetic macular edema (DME), respectively. Additionally, subgroup data from PHOTON in DME across sex, age, race and ethnicity will be presented, as well as a pooled safety analysis from the PULSAR, PHOTON and Phase 2 CANDELA trials.
Two-year data from the pivotal PULSAR trial were previously presented at the EURETINA Congress in October 2023. Two-year data from the pivotal PHOTON trial were previously presented at the American Society of Retina Specialists (ASRS) annual meeting in July 2023.
EYLEA HD (known as aflibercept 8 mg outside of the U.S.) 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 following any regulatory approvals.
EYLEA HD and EYLEA presentations at AAO:
| Abstract title | Session | Lead author | Presentation date, time (PST), location |
| EYLEA HD | |||
| Aflibercept 8mg for Diabetic Macular Edema: 96-Week Results of the PHOTON Study | RET11 Podium Presentation | Diana V. Do, M.D. | Friday, November 3 5:02 – 5:08 PM WEST 3004 |
| Aflibercept 8 mg in Patients With Neovascular AMD: Phase 3 PULSAR Trial 96-Week Results* | RET10 Podium Presentation | Jean-Francois Korobelnik, M.D. | Friday, November 3 4:13 – 4:18 PM WEST 3004 |
| Intravitreal Aflibercept 8 mg for DME: Week 48 Efficacy Outcomes by Baseline Demographics in the Phase 2/3 PHOTON Trial | PA025 Podium Presentation | Sean Adrean, M.D. | Sunday, November 5 8:00 – 8:07 AM WEST 2006 |
| Pooled Safety Analysis of Aflibercept 8 mg in the CANDELA, PHOTON and PULSAR Trials | PO551 ePoster | Veeral Sheth, M.D. | Available on demand |
| Characteristics of Patients Who Did or Did Not Maintain Aflibercept 8-mg Dosing Intervals in the Phase 2/3 PHOTON Trial | PO519 ePoster | Dennis M. Marcus, M.D. | Available on demand |
| Intravitreal Aflibercept 8 mg in Patients With PCV: PULSAR Subgroup Analysis* | PO508 ePoster | Timothy Y. Lai, M.D., FRCOphth, FRCS | Available on demand |
| Intravitreal Aflibercept 8-mg Injection in Patients With nAMD: Subgroup Analyses From the Phase 3 PULSAR Trial* | PO512 ePoster | David A. Eichenbaum, M.D. | Available on demand |
| Early Fluid Resolution Association With Treatment Interval Maintenance at Week 48 in Patients Receiving Aflibercept 8 mg: Phase 3 PULSAR Trial* | PO474 ePoster | Varun Chaudhary, M.D. | Available on demand |
| EYLEA | |||
| Two-Year Outcomes From FIREFLEYE Next, a Prospective Long-Term Follow-Up Study After Treatment of ROP With Aflibercept vs. Laser* | PA021 Podium Presentation | Andreas Stahl, M.D. | Saturday, November 4 4:09 – 4:16 PM WEST 2006 |
*Bayer-run trial
About the EYLEA HD Clinical Trial Program
PULSAR in wAMD and PHOTON in DME/diabetic retinopathy (DR) 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.
CANDELA was a Regeneron-sponsored Phase 2 trial investigating the safety and efficacy of EYLEA HD extended dosing regimens compared to EYLEA in wAMD patients.
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) 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) 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 and retinal detachment (separation of retina from back of the eye) can occur. Inflammation in the eye has been reported with the use of EYLEA HD and EYLEA.
- 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.
- Contact your doctor right away if you think you or your baby might be experiencing any side effects, including eye pain or redness, light sensitivity, or blurring of vision, after an injection.
- 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 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. Regeneron’s 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
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| Contacts: | |
| Media Relations Mary Heather Tel: +1 914-847-8650 mary.heather@regeneron.com | Investor Relations Mark Hudson Tel: +1 914-847-3482 mark.hudson@regeneron.com |
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