JAPAN – The Japanese Ministry of Health, Labour and Welfare has granted marketing authorization in Japan for Eylea injection 8 mg for the treatment of neovascular (wet) age-related macular degeneration (nAMD) and diabetic macular edema (DME).

The Japan approval coincides with Bayer Group introducing a new operating model called “Dynamic Shared Ownership” (DSO) worldwide.

This new operating model is anticipated to reduce hierarchies, eliminate bureaucracy, streamline structures, and accelerate decision-making processes, in addition to making the company much more agile and significantly improve its operational performance.

As such, the marketing approval of Eylea injection 8 mg in Japan demonstrates the Group’s supporting efforts to master the major health challenges presented by a growing and aging global population.

In a press release, Michael Devoy, Chief Medical Officer at Bayer’s Pharmaceuticals Division, said: “The approval of Eylea 8 mg in Japan is a turning point in retinal care.”

Michael Devoy observed that Eylea 2 mg had already transformed the treatment landscape a decade ago and is the standard of care in neovascular age-related macular degeneration and diabetic macular edema.

Jointly developed by Bayer and Regeneron, Eylea 8 mg (aflibercept 8 mg) has emerged as an exciting new advancement in the treatment of our patients with serious retinal diseases.

Japanese patients with nAMD or DME can now receive less frequent injections after their initial monthly doses and still experience similar visual gains, anatomic improvements, and the safety profile of Eylea 8 mg.

Through this strategic alliance, Regeneron maintains exclusive rights to Eylea 2 mg (aflibercept 2 mg) and Eylea HD in the United States.

Bayer has licensed 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.

As a global enterprise with core competencies in the life science fields of health care and nutrition, Bayer has submitted regulatory applications for aflibercept 8 mg in additional markets.

The approval of aflibercept 8 mg in Japan comes shortly after the drug was approved for use under the brand name Eylea HD by the United States Food and Drug Administration (FDA) in August 2023.

In addition to the FDA approval, 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.

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,” Michael Devoy added.

Moreover, the marketing approval in Japan is based on positive results from the PULSAR clinical trial in neovascular age-related macular degeneration and the PHOTON clinical trial in diabetic macular edema.

In the two clinical trials, Eylea 8 mg (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.

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 his address, Satoshi Yamanaka, Country Medical Director and Head of Medical Affairs & Pharmacovigilance at Bayer Yakuhin in Japan, stated: “The approval of Eylea 8 mg marks a significant step in advancing clinical practice of retinal diseases in Japan.”

Satoshi Yamanaka expressed his concern about many patients struggling with long-term compliance while noting Eylea 8 mg will allow for extended treatment intervals.

He explained that 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 approval would mean a considerable reduction of disease burden for patients, while also alleviating patient management for physicians,” Satoshi Yamanaka reassured Japanese patients.

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