Bayer to present new aflibercept 8 mg 60-week and 96-week data for patients with neovascular (wet) age-related macular degeneration and diabetic macular edema

Berlin, September 28, 2023 – Bayer and its collaborator Regeneron will present new clinical data and analyses for aflibercept 8 mg at the Annual Meeting of European Society of Retina Specialists 2023, in Amsterdam, The Netherlands, 5-8 October 2023.

The aflibercept 8 mg data will highlight Bayer’s commitment to addressing the unmet need of extended treatment intervals in exudative retinal disease. A key secondary endpoint from the 60-week data from the pivotal PULSAR and PHOTON aflibercept 8 mg studies will be presented for the very first time. Additionally, the two-year data from the PULSAR and PHOTON studies will further demonstrate the potential of achieving sustained disease control, meaning greater and longer lasting control of disease activity versus the study comparator.

The aflibercept 8 mg data and analysis will provide further insights into durability results of extended treatment intervals, as well as efficacy and safety of aflibercept 8 mg versus aflibercept 2 mg (Eylea^TM) in patients with neovascular (wet) age-related macular degeneration (nAMD) and diabetic macular edema (DME).

The following key abstracts for aflibercept 8 mg will be presented at EURETINA 2023:

• Intravitreal Aflibercept 8 mg Injection in Patients with Neovascular Age-Related Macular Degeneration: 60-Week Results from the Phase 3 PULSAR Trial

o   Free Paper Session 3: AMD I
o   October 5, 15:37-15:43 CEST

A presentation of the 60-week visual and anatomic outcomes and safety data from the Phase III PULSAR trial, plus the proportion of patients with nAMD receiving aflibercept 8 mg who were eligible for dosing interval extension to every 20 weeks. The presentation will also include the 96-week visual and anatomic outcomes, and the proportion of patients with extended dosing regimens of up to 24 weeks compared to Eylea (aflibercept 2 mg).

•  Aflibercept 8 mg for Diabetic Macular Edema: 60-Week Results from the Phase 2/3 PHOTON Trial

o   Audio-Narrated Free Paper
o   Available on terminals throughout congress

This session will outline 60-week visual and anatomic outcomes and safety data from the Phase II / III PHOTON trial, examining patients with diabetic macular edema (DME) receiving aflibercept 8 mg compared to Eylea (aflibercept 2 mg).

• Aflibercept 8 mg for Diabetic Macular Edema: 96-Week Results from the Phase 2/3 PHOTON Trial

o   Free Paper Session 8
o   October 6, 16:43-16:49 CEST

The two-year data from the PHOTON trial investigates aflibercept 8 mg with extended dosing regimens of up to 24 weeks in diabetic macular edema (DME) compared to the current standard of care Eylea (aflibercept 2 mg) with fixed intervals of 8 weeks.

• Early Fluid Resolution Association with Treatment Interval Maintenance at week 48 in Treatment-Naive Neovascular Age-Related Macular Degeneration Patients receiving Aflibercept 8 mg: Post-hoc Analysis of the Phase 3 PULSAR Trial

o   Audio-Narrated Free Paper
o   Available on terminals throughout congress

This session will outline data from the Phase III PULSAR trial analyzing the association between early fluid resolution during the initial monthly injection phase and the proportion of patients maintaining extended dosing intervals with aflibercept 8 mg.

• Pooled Safety Analysis of Aflibercept 8 mg in the CANDELA, PHOTON, and PULSAR Trials

o   Speakers' Corner 10: AMD IV
o   October 7, 12:31-12:36 CEST

The pooled safety analysis compares the safety of aflibercept 8 mg with aflibercept 2 mg across the clinical trial program which includes data from the phase II trial CANDELA in nAMD and the pivotal phase II/III trial PHOTON in DME and the phase III trial PULSAR in nAMD.

• Opportunities to improve clinical management of diabetic retinopathy and diabetic macular edema: Insights from global survey data of patients, providers, and clinic staff from 24 countries

o   Free Paper Session 7: Diabetes & Vascular Diseases II
o   October 6, 15:28-15:34 CEST

The global Barometer survey highlights opportunities to improve the clinical management of diabetic retinopathy and diabetic macular edema. This survey provides unique, quantifiable insights into the scale and breadth of the key challenges patients face from various perspectives. The persistent worldwide appointment and disease burden uncovered in these data should be perceived as an opportunity to improve clinical management of DR/DME.

• A global survey of patients, providers, and clinic staff from 24 countries reveals barriers to optimal care delivery for nAMD due to constraints and gaps in clinic capacity

o   Free Paper Session 8: AMD II
o   October 6, 16:55-17:01 CEST

The global Barometer survey of patients, providers, and clinic staff reveals barriers to optimal care delivery for nAMD due to constrains and gaps in clinic capacity. This survey provides important and novel insights into the scale and breadth of key challenges in clinical management of nAMD as perceived by patients, providers, and clinic staff. Addressing opportunities highlighted in this novel survey could enhance care by alleviating treatment burden and improving clinic capacity.

Aflibercept 8 mg is being jointly developed by Bayer and Regeneron. Regeneron maintains exclusive rights to Eylea (aflibercept 2 mg) 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 2 mg).

Aflibercept 8 mg was approved for use by the FDA on August 18, 2023. Bayer has submitted regulatory applications for aflibercept 8 mg in Europe and additional markets, but its safety and efficacy have not yet been fully evaluated by any regulatory authority outside of the U.S.

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, PHOTON and CANDELA
PULSAR and PHOTON are randomized, 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. The two-year data mark the end of the masked study (week 96) with the option to extend treatment intervals up to 24 weeks and with an optional 1-year open-label extension for patients until week 156. Patients in both clinical trials were randomized at baseline 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 the first year, patients in the aflibercept 8 mg groups could have their dosing intervals shortened down to an every 8-week interval if DRM criteria for disease progression were observed. Intervals could not be extended until the second year of the study. In the second year, patients in the aflibercept 8 mg groups could have their dosing intervals shortened or extended if DRM criteria were met. Patients in all Eylea (aflibercept 2 mg) groups maintained a fixed 8-week dosing regimen throughout their participation in the trials. The lead sponsors of the trials were Bayer for PULSAR and Regeneron for PHOTON.

CANDELA was a Phase II trial investigating aflibercept 8 mg in 106 treatment-naïve patients with nAMD conducted between 2019 and 2021. The trial was designed to investigate the safety of aflibercept 8 mg compared to Eylea (aflibercept 2 mg) in patients with nAMD.

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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