Regeneron Pharmaceuticals, Inc. 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). 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, 79% and 77% of wAMD patients and 91% and 89% of DME patients, who were respectively randomized to 12- and 16-week dosing, maintained these extended dosing intervals through 48 weeks. The most common adverse reactions (=3%) reported in patients treated with EYLEA HD were cataract, conjunctival hemorrhage, intraocular pressure increased, ocular discomfort/eye pain/eye irritation, vision blurred, vitreous floaters, vitreous detachment, corneal epithelium defect, and retinal hemorrhage.

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. 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. 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.