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 greater and longer 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.