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Bayer initiates phase III study to investigate aflibercept 8 mg in retinal vein occlusion

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Global phase III QUASAR study will assess the efficacy and safety of aflibercept 8 mg in macular edema secondary to retinal vein occlusion (RVO) / Study comes after positive data from the phase III PULSAR trial in neovascular (wet) age-related macular degeneration (nAMD) and phase II/III PHOTON trial in diabetic macular edema (DME) / QUASAR is expected to enroll around 800 patients in 27 countries / Study will add to the robust development program for aflibercept 8 mg, exploring the potential to achieve visual acuity with extended treatment intervals in additional patient populations

Berlin, May 10, 2023 – Bayer today announced the initiation of the phase III QUASAR study, designed to evaluate the efficacy and safety of aflibercept 8 mg dosed at extended treatment intervals compared to the standard of care, Eylea (aflibercept 2 mg) in macular edema secondary to retinal vein occlusion (RVO).

The QUASAR clinical trial will measure changes in best corrected visual acuity (BCVA) in patients who receive aflibercept 8 mg with extended treatment intervals after initial monthly doses and those who receive Eylea (aflibercept 2 mg) every 4 weeks, until the primary endpoint is assessed at week 36. Treatment intervals can be further extended after the week 36 timepoint. Aflibercept 8 mg has been developed with the aim to extend intervals between injections without compromising vision gains and safety.

“Secondary macular edema is the most common cause of sight loss in retinal vein occlusion. If left untreated, it can cause severe vision loss and can make the simplest tasks, such as driving, walking downstairs, or reading, difficult to complete. We have seen promising positive results of aflibercept 8 mg given at extended treatment intervals in patients with neovascular age-related macular degeneration and diabetic macular edema, so it is important that we also evaluate its potential in retinal vein occlusion,” said Dr. Christian Rommel, Member of the Executive Committee of Bayer’s Pharmaceuticals Division and Head of Research and Development.

“We know that there is a high disease burden with frequent injections in exudative retinal diseases which contributes to poor adherence to treatment and vision loss. Thus, we welcome new research in extended treatment intervals that alleviate the situation for patients and the health care systems while achieving best visual acuity outcomes”, said Dr. Varun Chaudhary, Chief of Ophthalmology and Professor of Surgery at Hamilton Regional Eye Institute, McMaster University, Canada.

Eylea (aflibercept 2 mg) is the standard of care treatment for macular edema secondary to RVO and is approved for central retinal vein occlusion (CRVO) and branch retinal vein occlusion (BRVO) in over 100 countries worldwide.

The phase III QUASAR clinical trial in macular edema secondary to RVO follows the application for regulatory authorization of aflibercept 8 mg in the EU, Japan, and other markets for the treatment of nAMD and DME. The submissions are based on positive efficacy and safety data from the phase III PULSAR trial in nAMD and the phase II/III PHOTON trial in DME, in which both studies met their primary endpoint of non-inferiority in BCVA at 48 weeks of aflibercept 8 mg with two extended dosing regimens (every 12 and every 16 weeks), compared to Eylea (aflibercept 2 mg) dosed every 8 weeks, following initial monthly doses.

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 fully evaluated by any regulatory authority.

The QUASAR trial is a global randomized, double-masked, active-controlled phase III study evaluating the efficacy and safety of aflibercept 8 mg used with extended dosing regimens in macular edema secondary to retinal vein occlusion. The primary endpoint of this study is to document change in BCVA, as measured by the Early Treatment Diabetic Retinopathy Study (ETDRS) letter score, from the date of randomization through 36 weeks of treatment. The study compares BCVA changes between patients who received aflibercept 8 mg with extended treatment intervals following initial monthly doses compared to Eylea (aflibercept 2 mg) every 4 weeks. Treatment intervals may be further adjusted based on treatment response. Patients will be treated up to week 60 followed by a monitoring period until week 64. The trial is expected to enroll around 800 patients.

About RVO
Retinal vein occlusion (RVO) is a chronic condition that currently affects 28 million adults globally and can lead to sudden, rapid vision loss. There are two types of RVO – central retinal vein occlusion (CRVO) and branch retinal vein occlusion (BRVO). CRVO occurs when there is a blockage in the main vein of the retina at the optic nerve, and this impairs blood drainage from the retina and can result in vision loss. BRVO occurs when the smaller, branch retinal veins are obstructed, and is up to six times more common than CRVO. Blockages caused by RVO reduce the oxygen supply to the retina, increasing the production of vascular endothelial growth factor (VEGF) and placental growth factor (PlGF). The blocked vein causes fluid and blood to leak into the retina and resulting in a swelling of the macula, the center of the retina responsible for fine vision. This swelling is called macular edema and VEGF plays a major role in driving this pathology.

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 to www.bayer.com.

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Forward-Looking Statements
This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or development



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