Regeneron Pharmaceuticals Announces Eylea Hd Approval for Extended Dosing Intervals in Wet Age-Related Macular Degeneration and Diabetic Macular Edema

Regeneron Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration has approved the extension of dosing intervals for EYLEA HD (aflibercept) up to every 20 weeks for patients with wet age-related macular degeneration (wAMD) and diabetic macular edema (DME) following one year of successful response based on visual and anatomic outcomes. As part of the approval, the FDA has updated the EYLEA HD label to include 96-week (2-year) data from the pivotal PULSAR trial in wAMD and the pivotal PHOTON trial in DME, demonstrating sustained efficacy and safety through 2 years with extended dosing intervals. With this latest approval, dosing with EYLEA HD can now be individualized for patients with wAMD and DME, some of whom may need treatment as frequently as every 4 weeks, as well as those who can successfully be extended to treatment as infrequently as every 20 weeks, based on criteria described in the U.S. Prescribing Information.

This further extends the widest range of dosing intervals of any approved injectable anti-VEGF. The EYLEA HD label was also updated to include data through 96 weeks from both trials. Of the EYLEA HD patients who completed week 96 (PULSAR n=583, PHOTON n=395), the vast majority maintained or further extended their dosing intervals while visual and anatomic improvements remained consistent with those achieved in the first 48 weeks, including: 71% and 47% of wAMD patients attained last assigned dosing intervals of =16- and =20-week intervals, respectively, at week 96; 72% and 44% of DME patients attained last assigned dosing intervals of =16- and =20-week intervals, respectively, at week 96.

The most common adverse reactions (=3%) reported in patients treated with EYLEA HD across approved indications were cataract, conjunctival hemorrhage, corneal epithelium defect, intraocular pressure increased, ocular discomfort/eye pain/eye irritation, retinal hemorrhage, vision blurred, vitreous detachment and vitreous floaters. Beyond the approval, the FDA also has a target action date in April 2026 for the EYLEA HD prefilled syringe, which is under review through a Chemistry, Manufacturing and Controls Prior-Approval Supplement. PULSAR in wAMD and PHOTON in DME/Diabetic Retinopathy (DR) were double-masked, active-controlled pivotal trials that were conducted in multiple centers globally.

The lead sponsors of the trials were Bayer for PULSAR and Regeneron for PHOTON. In both trials, patients were randomized into 3 treatment groups to receive either: EYLEA HD every 3 months, EYLEA HD every 4 months, or EYLEA every 2 months. 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 to an every 2-month interval if protocol-defined criteria for disease progression were observed. Beginning in the second year, intervals could also be extended. Patients in all EYLEA groups maintained a fixed 2-month dosing regimen throughout their participation in the two-year trials.

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 1,400,000 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 1,500,000 adults are diagnosed with DME, while approximately 6,000,000 people have DR without DME. Over a decade ago, Regeneron introduced EYLEA (aflibercept), a vascular endothelial growth factor inhibitor, and transformed the treatment paradigm for certain serious chorioretinal vascular diseases.

With a well-established efficacy and consistent safety profile from 16 pivotal trials, EYLEA is approved to treat vision-threatening conditions that impact patients from their earliest days, such as retinopathy of prematurity (ROP), to their later years, including diabetic macular edema (DME), diabetic retinopathy (DR), macular edema following retinal vein occlusion (RVO) and wet age-related macular degeneration (wAMD). EYLEA HD was developed to achieve comparable efficacy and safety to EYLEA, but with fewer injections. EYLEA HD is supported by a robust body of research and is currently approved in the U.S. to treat patients with wAMD, DME, DR and RVO.

EYLEA HD (known as Eylea 8 mg in the European Union and Japan) is being jointly developed by Regeneron and Bayer AG. Regeneron maintains exclusive rights to EYLEA and EYLEA HD in the U.S. 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. 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) and Macular Edema following Retinal Vein Occlusion (RVO).

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). EYLEA HD and EYLEA are administered by injection into the eye. 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.

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.