Berlin, September DD, 2022 – Bayer and Regeneron Pharmaceuticals, Inc. announced today the topline results of their Phase III PULSAR and Phase II/III PHOTON clinical trials, evaluating the safety and effectiveness of aflibercept 8 mg in neovascular age-related macular degeneration (nAMD) and diabetic macular oedema (DME). Both trials met their primary endpoints, demonstrating non-inferiority for aflibercept 8 mg versus Standard of Care (SoC) EyleaTM (aflibercept 2 mg) in mean change in best-corrected visual acuity (BCVA) after 48 weeks. Both studies have three treatment arms, with participants randomised to receive either aflibercept 8 mg every 16 weeks, every 12 weeks or aflibercept 2 mg every 8 weeks, after 3 initial 4-weekly loading doses. In the 8 mg treatment arm with injections every 16 weeks 77% of patients in PULSAR and 89% in PHOTON achieved the same visual acuity outcomes as the comparator arm with Eylea given every 8 weeks. Aflibercept 8 mg is a new formulation that was jointly developed by the companies to reduce the treatment burden in treatment intensive patients and those already successfully managed with their current therapy through further extending the injection intervals. Eylea (aflibercept 2 mg) is the gold standard for treatment of nAMD and DME for a decade.

“Although 90 % of vision loss is preventable, globally there are approximately 1.1 billion people who are impacted by vision loss. This is our motivation to optimise treatment plans and drive change for patients,“ said Dr. Christian Rommel, Member of the Executive Committee of Bayer AG`s Pharmaceutical Division and Head of Research and Development. “Neovascular age-related AMD is one of the leading causes of irreversible blindness and around one third of people with diabetes go on to develop diabetic retinopathy in their lifetimes. - We have already seen that certain patients are able to achieve excellent visual outcomes on extended dosing intervals up to 16 weeks with Eylea 2 mg. With the new aflibercept 8 mg formulation we have shown in two major studies that we can for the majority of all patients with neovascular age-related AMD and DME extend the time between the treatments up to 16 weeks without compromising their visual acuity. This translates for many patients into lower treatment burden and a higher quality of life.”

The PHOTON and PULSAR trials are both multi-centres, randomized, double-masked, active-controlled clinical trials to assess the efficacy and safety of aflibercept 8 mg in treatment intervals of 12 weeks and 16 weeks compared to aflibercept 2 mg administered at an interval of 8 weeks, after the initial loading phase. The primary endpoint for both trials is the mean change in best-corrected visual acuity (BCVA) at week 48. The PHOTON trial included 660 patients and PULSAR 1,016 patients. The clinical data from the trials will be presented at an upcoming scientific meeting.

Bayer and Regeneron Pharmaceuticals, Inc. are collaborating on the global development of aflibercept 8 mg. Regeneron maintains exclusive rights to Eylea 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, except for Japan where Regeneron receives a percentage of net sales.

About aflibercept 8 mg

Aflibercept 8 mg is being jointly developed by Bayer and Regeneron. This new, high molar dose aflibercept formulation enables a greater amount of medicine to be administered with each treatment and could potentially extend the time between doses while retaining the efficacy and safety profile seen with Eylea (aflibercept 2 mg). Aflibercept 8 mg is currently under clinical development and its safety and efficacy have not been fully evaluated by any regulatory authority.

About VEGF and Eylea (aflibercept solution for injection into the eye)

Vascular Endothelial Growth Factor (VEGF) is a naturally occurring protein in the body. Its normal role in a healthy organism is to trigger formation of new blood vessels (angiogenesis) supporting the growth of the body's tissues and organs. It is also associated with the growth of abnormal new blood vessels in the eye, which exhibit abnormal increased permeability that leads to edema.

Aflibercept solution for injection is a recombinant fusion protein, consisting of portions of human VEGF receptors 1 and 2 extracellular domains fused to the Fc portion of human IgG1 and formulated as an iso-osmotic solution for intravitreal administration. Aflibercept acts as a soluble decoy receptor that binds VEGF-A and Placental Growth Factor (PIGF) and thereby can inhibit the binding and activation of their cognate VEGF receptors.

Aflibercept has been approved under the brand name Eylea in more than 100 countries for five indications for adults, which in addition to the treatment of visual impairment due to diabetic macular oedema (DME) and neovascular (wet) age-related macular degeneration (nAMD), includes the treatment of visual impairment due to: macular oedema following retinal vein occlusion (RVO; branch RVO or central RVO) and myopic choroidal neovascularization (myopic CNV). Over 55 million vials of Eylea have been sold since its launch worldwide, resulting in over seven million patient years of experience.

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 planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to drive sustainable development and generate 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 2021, the Group employed around 100,000 people and had sales of 44.1 billion euros. R&D expenses before special items amounted to 5.3 billion euros. For more information, go to www.bayer.com.

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ak (2022-0125E)