88% of EYLEA HD patients had a last assigned dosing interval of ≥12 weeks at week 156, while sustaining visual and anatomic improvements achieved in the first 96 weeks, in this extension study of the Phase 3 PHOTON trial presented at AAO
Patients switched to EYLEA HD experienced substantially slower fluid reaccumulation, as compared to their previous rate of fluid reaccumulation with EYLEA® (aflibercept) Injection 2 mg
The consistent achievement of much longer dosing intervals with EYLEA HD – together with the notably slower fluid reaccumulation observed following switch to EYLEA HD – supports the longer duration of action of EYLEA HD versus EYLEA
Safety data remains consistent with the known EYLEA HD and EYLEA safety profiles
Oct. 18, 2024 -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced positive three-year (156-week) data for EYLEA HD® (aflibercept) Injection 8 mg from an extension study of the Phase 3 PHOTON trial in patients with diabetic macular edema (DME). At three years, the longer-term data showed the vast majority of EYLEA HD patients who entered the extension study sustained the visual gains and anatomic improvements achieved by the end of the second year, while achieving substantially longer treatment intervals than have been previously demonstrated. Notably, patients switched to EYLEA HD experienced substantially slower fluid reaccumulation following their first EYLEA HD dose. The achievement of much longer dosing intervals with EYLEA HD – together with the notably slower fluid reaccumulation – supports the longer duration of action of EYLEA HD. The results were presented today in a late-breaking session at the American Academy of Ophthalmology (AAO) Annual meeting.
“Many patients with diabetic eye disease are of working age and often have to juggle a high burden of healthcare appointments and treatments alongside job and family commitments. These latest three-year results from the Phase 3 PHOTON trial continue to demonstrate that EYLEA HD can safely provide meaningful and lasting vision and anatomical benefits for people living with diabetic macular edema – with as few as three or four injections per year,” said Diana V. Do, M.D., Professor of Ophthalmology and Vice Chair for Clinical Affairs at the Byers Eye Institute, Stanford University and a trial investigator. “Over the last year, EYLEA HD has made an impact on how diabetic eye disease is managed among retina specialists, and these longer-term results reinforce confidence in initiating patients on EYLEA HD as a first-line treatment.”
In PHOTON, EYLEA HD patients were initially randomized at baseline to either 12- or 16-week dosing intervals (after three initial monthly doses). If pre-specified criteria were met, dosing intervals could be shortened throughout the trial or extended in the second and third year. As previously presented, 89% of all EYLEA HD patients completing week 96 maintained ≥12-week dosing intervals. Patients could then participate in an optional extension study for an additional 60 weeks. Of the EYLEA HD patients (n=152) who completed the full 156 weeks of treatment:
88% were assigned a dosing interval of ≥12 weeks, and 48% were assigned a dosing interval of ≥20 weeks, at the end of three years of treatment.
Vision gains and anatomical improvements achieved through year two in PHOTON were sustained through year three in the extension study.
Patients in the PHOTON comparator arm received EYLEA® (aflibercept) Injection 2 mg as a fixed 8-week dosing regimen (after five initial monthly doses) for 96 weeks. These patients were then able to enter the extension study at week 96 and switch to a 12-week dosing interval with EYLEA HD. Of these patients who completed the extension study (n=58), 83% had a last assigned dosing interval ≥12 weeks at the end of the study (week 156), while mean visual and anatomic improvements achieved with EYLEA in the first 96 weeks were sustained following the switch to longer dosing intervals with EYLEA HD. Notably, patients synchronously switched to the EYLEA HD dose experienced substantially slower fluid reaccumulation following their first dose – as compared to their previous rate of fluid reaccumulation while on EYLEA treatment. The consistent achievement of much longer dosing intervals with EYLEA HD – together with the notably slower fluid reaccumulation observed following switch to EYLEA HD – support the longer duration of action of EYLEA HD versus EYLEA.
In the extension study, the safety profile of EYLEA HD (n=265) continued to be similar to EYLEA through three years and remained generally consistent with the known safety profile of EYLEA HD in its pivotal trials. Ocular treatment emergent adverse events (TEAEs) occurring in ≥4% of all patients included cataract, vitreous floaters, and diabetic retinal edema. There were no cases of occlusive retinal vasculitis. The rate of intraocular inflammation was 1.4% for the patients that switched from EYLEA to EYLEA HD, and 1.5% for the EYLEA HD patients randomized at baseline. Anti-platelet trialists' collaboration-defined arterial thromboembolic TEAEs occurred in 7% of patients in both groups.
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.
PULSAR in wet age-related macular degeneration and PHOTON in DME/diabetic retinopathy (DR) are double-masked, active-controlled pivotal trials that were 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 two-year trials.
In both studies, there was an optional extension study starting at week 96, with all participating patients receiving EYLEA HD through week 156. Patients initially randomized to EYLEA in PHOTON, were switched to EYLEA HD at the start of the extension study and immediately assigned to a 12-week dosing interval. Dosing intervals for all patients in the extension study could be shortened or extended by 2-week increments if protocol-defined criteria were met, with a minimum dosing interval of every 8 weeks and a maximum dosing interval of every 24 weeks.
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.
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, 12 years of real-world experience, and more than 80 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.
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.
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