Bayer : submits aflibercept 8 mg for marketing authorization in Japan

Berlin, March 1, 2023 - Bayer has submitted an application to the Japanese Ministry of Health, Labor, and Welfare (MHLW) seeking approval of aflibercept 8 mg for the treatment of two major retinal diseases, neovascular (wet) age-related macular degeneration (nAMD) and diabetic macular edema (DME). The MHLW submission is based on positive results from both the phase III PULSAR trial in nAMD and the phase II/III PHOTON trial in DME, in which aflibercept 8 mg met its primary endpoint, respectively. Aflibercept 8 mg has been developed with the aim to increase intervals between injections without compromising vision gains.

"Extended treatment intervals meet an important patient need by significantly reducing the disease burden for patients with exudative retinal diseases. Aflibercept 8 mg has been shown to be highly durable, with comparable visual acuity and safety to the gold standard, Eylea. Once approved, we look forward to bringing this innovation to patients in Japan," said Dr. Christian Rommel, Member of the Executive Committee of Bayer's Pharmaceutical Division and Head of Research and Development.

In the clinical trials PULSAR and PHOTON, aflibercept 8 mg demonstrated comparable visual acuity with extended treatment intervals of every 12 and every 16 weeks to the standard of care Eylea^TM (aflibercept 2 mg) dosed every 8 weeks, following initial monthly doses, at week 48. Aflibercept 8 mg showed unprecedented durability with 77% of nAMD patients and 89% of DME patients randomized to the 16-week dosing arm achieving and maintaining 16-week treatment intervals with an average of only 5 injections through week 48. 79% of nAMD patients and 91% of DME patients randomized to the aflibercept 8 mg 12-week dosing arm maintained their interval with an average of 6 injections through week 48. Aflibercept 8 mg showed also rapid and resilient fluid control to the comparator Eylea (aflibercept 2 mg) through to week 48.

The safety of aflibercept 8 mg in both trials was similar to the well-established safety profile of Eylea (aflibercept 2 mg) and consistent with previous clinical trials. The rates of intraocular inflammation and intraocular pressure increase for aflibercept 8 mg were low and similar to Eylea (aflibercept 2 mg). In both trials, there were no cases of endophthalmitis, retinal vasculitis and no new safety signals through to week 48.

Aflibercept 8 mg is being jointly developed by Bayer and Regeneron. Regeneron maintains exclusive rights to Eylea and aflibercept 8 mg 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.

Aflibercept 8 mg is investigational, and its safety and efficacy have not yet been evaluated by any regulatory authority.

About aflibercept 8 mg
Aflibercept 8 mg has been developed with the aim to increase intervals between injections without compromising vision gains. Aflibercept 8 mg was investigated in neovascular (wet) age-related macular degeneration (PULSAR) and diabetic macular edema (PHOTON) to evaluate efficacy and safety compared to Eylea (aflibercept 2 mg).

About PULSAR and PHOTON
PULSAR and PHOTON are 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) at week 48. Patients in both clinical trials were randomized at baseline and assigned 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 both clinical trials patients on aflibercept 8 mg arms were assessed at multiple time points for DRM criteria to secure appropriate disease control through week 48.

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 as little as three 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.

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).

About Bayer
Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. Its products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2022, the Group employed around 101,000 people and had sales of 50.7 billion euros. R&D expenses before special items amounted to 6.2 billion euros. For more information, go towww.bayer.com.

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