New Eylea™ 8 mg approved in Japan
Not intended for U.S. and UK Media
Japanese Ministry of Health, Labour and Welfare (MHLW) approved new Eylea 8 mg (aflibercept 8 mg) for neovascular (wet) age-related macular degeneration (nAMD) and diabetic macular edema (DME) based on positive results from clinical trials PULSAR and PHOTON
Berlin, January 18, 2024 – The Japanese Ministry of Health, Labour and Welfare (MHLW) has granted market authorization for Eylea™ 8 mg (aflibercept 8 mg) for the treatment of neovascular (wet) age-related macular degeneration (nAMD) and diabetic macular edema (DME). The approval is based on positive results from the PULSAR clinical trial in nAMD and the PHOTON clinical trial in DME. In these clinical trials, aflibercept 8 mg demonstrated unprecedented durability for the vast majority of patients with less frequent injections and comparable efficacy and safety to Eylea™ 2 mg (aflibercept 2 mg) with a fixed 8-week treatment interval.
“The approval of Eylea 8 mg in Japan is a turning point in retinal care. Eylea 2 mg already transformed the treatment landscape a decade ago and is the standard of care in nAMD and DME today. Building on this high therapeutic standard, patients now have the option to benefit from Eylea 8 mg with less frequent injections and still experience lasting vision gains, rapid and resilient fluid control, and comparable safety to Eylea 2 mg,” said Michael Devoy, Chief Medical Officer at Bayer’s Pharmaceuticals Division.
“The approval of Eylea 8 mg marks a significant step in advancing clinical practice of retinal diseases in Japan. Many patients struggle with long-term compliance. Eylea 8 mg will allow for extended treatment intervals, thus providing sustained disease control with great and long lasting control of the underlying disease. This would mean a considerable reduction of disease burden for patients, while also alleviating patient management for physicians,” said Satoshi Yamanaka, Country Medical Director and Head of Medical Affairs & Pharmacovigilance at Bayer Yakuhin in Japan.
The approval in Japan is based on data from the PULSAR clinical trial in nAMD and the PHOTON trial in DME. Both studies met their primary endpoint of non-inferior best corrected visual acuity (BCVA) changes with aflibercept 8 mg with 12- or 16-week dosing regimens compared to Eylea (aflibercept 2 mg) with a fixed 8-week treatment interval at week 48, following initial monthly doses. In these studies, the safety profile of aflibercept 8 mg was consistent with the well-established safety profile of Eylea (aflibercept 2 mg).
Aflibercept 8 mg was approved for use under the brand name Eylea HD by the United States Food and Drug Administration (FDA) in August 2023. In January 2024, the European Commission has granted marketing authorization in the European Union for Eylea 8 mg (aflibercept 8 mg, 114.3 mg/ml solution for injection) in nAMD and DME. Bayer has submitted regulatory applications for aflibercept 8 mg in additional markets.
Eylea 8 mg (aflibercept 8 mg; in the United States: Eylea HD) is being jointly developed by Bayer and Regeneron. Regeneron maintains exclusive rights to Eylea 2 mg (aflibercept 2 mg) and Eylea HD in the United States. Bayer has licensed the exclusive marketing rights outside the United States, where the companies share equally the profits from sales of Eylea 2 mg and Eylea 8 mg following any regulatory approvals.
About PULSAR and PHOTON
PULSAR and PHOTON are randomized, double-masked, active-controlled pivotal trials. Both trials were conducted in multiple centers globally with similar designs and endpoints. The Phase III PULSAR trial in nAMD and Phase II/III PHOTON trial in DME evaluated the efficacy and safety of aflibercept 8 mg with 12- and 16-week dosing regimens versus Eylea (aflibercept 2 mg) dosed every 8 weeks, following initial monthly doses, with the primary endpoint of non-inferiority in terms of best corrected visual acuity (BCVA) changes at week 48. The two-year data mark the end of the masked study (week 96) with the option to extend treatment intervals up to 24 weeks and with an optional 1-year open-label extension for patients until week 156. Patients in both clinical trials were randomized at baseline to the three different arms. Across both studies, 1,164 patients were treated with aflibercept 8 mg. All patients in the aflibercept 8 mg arms were continuously evaluated under stringent, clinically relevant, patient focused dose regimen modification (DRM) criteria starting from week 16 throughout the study. In the first year, patients in the aflibercept 8 mg groups could have their dosing intervals shortened down to an every 8-week interval if DRM criteria for disease progression were observed. Intervals could not be extended until the second year of the study. In the second year, patients in the aflibercept 8 mg groups could have their dosing intervals shortened or extended if DRM criteria were met. Patients in all Eylea (aflibercept 2 mg) groups maintained a fixed 8-week dosing regimen throughout their participation in the trials. The lead sponsors of the trials were Bayer for PULSAR and Regeneron for PHOTON.
About nAMD and DME
Neovascular (wet) age-related macular degeneration (nAMD) is an eye disease that progresses rapidly and if left untreated can lead to vision loss in a few months. nAMD is one of the leading causes of irreversible blindness and vision impairment around the world. nAMD 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. 196 million people worldwide are living with AMD – it is anticipated that this figure will increase to 288 million by 2040. Approximately 10-15% of people with AMD will develop the advanced form nAMD.
Diabetic macular edema (DME) is a common complication in eyes of people living with diabetes. DME occurs when high levels of blood sugar lead to damaged blood vessels in the eye that leak fluid into the macula. This can lead to vision loss and, in some cases, blindness. Globally, 146 million people are currently living with diabetic retinopathy (DR), which can develop into a more serious condition which is diabetic macular edema. DME is affecting around 21 million people globally.
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