EYLEA® HD (aflibercept) Injection 8 mg Two-year Results from Pivotal PULSAR Trial in Wet Age-related Macular Degeneration Presented at EURETINA
TARRYTOWN, N.Y., Oct. 05, 2023 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc., (NASDAQ: REGN) today announced the first presentation of positive two-year (96 weeks) results from the pivotal PULSAR trial investigating EYLEA® HD (aflibercept) Injection 8 mg with 12- and 16-week dosing regimens, compared to EYLEA® (aflibercept) Injection, in patients with wet age-related macular degeneration (wAMD). The results were presented with the 60-week results at the 23rd EURETINA Congress.
“EYLEA HD was approved in the U.S. based in part on strong one-year efficacy and safety outcomes from PULSAR in wet age-related macular degeneration,” said Charles C. Wykoff, M.D., Ph.D., Director of Research at Retina Consultants of Texas and a trial investigator. “These two-year outcomes from PULSAR show that EYLEA HD can deliver sustained and consistent visual and anatomic benefits with extended dosing intervals in the longer-term – helping to reduce the treatment burden for patients with exudative retinal diseases and reinforcing the potential of EYLEA HD as a new standard of care.”
PULSAR (N=1,009) is a double-masked, active-controlled pivotal trial evaluating non-inferiority of EYLEA HD 12-week (n=335) and 16-week (n=338) dosing regimens compared to an 8-week dosing regimen for EYLEA (n=336). All patients received three initial monthly doses. Patients receiving EYLEA HD could have their dosing intervals shortened to an every 8-week interval if protocol-defined criteria for disease progression were observed. Patients were only able to extend their dosing intervals in the second year by 4-week increments up to 24-weeks, if pre-specified criteria were met.
The PULSAR trial met its primary endpoint, with EYLEA HD patients achieving clinically equivalent vision gains to EYLEA at 48 weeks. As previously announced, EYLEA HD demonstrated durable vision gains at extended dosing intervals at the end of two years, with the mean number of injections administered being 9.7 for the 12-week EYLEA HD group, 8.2 for the 16-week EYLEA HD group, and 12.8 for the EYLEA group. As presented at EURETINA, efficacy results for EYLEA HD patients who completed the two-year follow-up were as follows:
- Among all patients, 88% were on a ≥12-week dosing interval at the end of two years, with 71% meeting the extension criteria for ≥16-week dosing intervals.
- Of patients assigned to ≥16-week dosing regimen at baseline, 78% were eligible for ≥16-week dosing at the end of two years, with 53% eligible for ≥20-dosing week intervals.
In PULSAR, the safety of EYLEA HD continued to be similar to EYLEA through two years and remained consistent with the known safety profile of EYLEA from previous clinical trials for wAMD. There were no cases of occlusive retinal vasculitis or endophthalmitis in the EYLEA HD groups. The rate of intraocular inflammation was 1.3% for the aflibercept 8 mg group and 2.1% for the EYLEA group. Anti-platelet trialists' collaboration-defined arterial thromboembolic treatment-emergent adverse events occurred in 1.8% of patients treated with aflibercept 8 mg and 3.3% of patients treated with EYLEA.
The full EURETINA presentation is available on the Regeneron website. The two-year data from the pivotal PHOTON trial for aflibercept 8 mg in diabetic macular edema (DME) and diabetic retinopathy (DR) were previously presented at the American Society of Retina Specialists annual meeting in July 2023.
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 following any regulatory approvals.
About the EYLEA HD Clinical Trial Program
PULSAR in wAMD and PHOTON in DME/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.
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 64 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
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.
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.
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