Bayer today announced two-year (96 weeks) topline results of the pivotal clinical trial PULSAR in patients with neovascular (wet) age-related macular degeneration (nAMD). The data reinforce sustained vision gains with unprecedented extended treatment intervals of aflibercept 8 mg reaching up to 24 weeks with efficacy and safety comparable to the current standard of care Eylea™ (aflibercept 2 mg) with fixed intervals of 8 weeks.
At two years (96 weeks), the aflibercept 8 mg combined groups demonstrated that 71% of patients reached a ≥16-week dosing interval, including 47% reaching 20-week or longer intervals and 28% reaching 24-week intervals. At the end of two years the proportion of patients reaching a ≥12-week dosing interval remained high (88% at two years vs. 83% at one year).
"These durability results are impressive and demonstrate the sustainable efficacy of treatment with aflibercept 8 mg throughout the second treatment year," said Professor Dr. Paolo Lanzetta, Chairman of the Department of Ophthalmology at the University of Udine, Italy, and a principal investigator of PULSAR. "Importantly, the vision outcomes for patients on extended treatment intervals with aflibercept 8 mg were consistent with the Eylea 2 mg comparator arm."
"I am thrilled about the two-year results of the PULSAR trial because they offer the potential to reduce the treatment burden for the vast majority of patients with neovascular age-related macular degeneration in the future. The data underline that aflibercept 8 mg provides sustained disease control with greater and longer-lasting control of the underlying disease compared to Eylea 2 mg dosed every 8 weeks," said Dr. Christian Rommel, Member of the Executive Committee of Bayer's Pharmaceuticals Division and Head of Research and Development. "If approved by regulatory authorities this may contribute to improve adherence and thus better patient outcomes."
Of those patients randomized at baseline to a 16-week dosing regimen, 78% reached ≥16-week dosing intervals through two years and 53% ≥20-week dosing intervals. The number of injections with aflibercept 8 mg was considerably reduced by 4.6 injections over two years down to a mean number of 8.2 injections in the 16-week-group versus 12.8 in the Eylea (aflibercept 2 mg) group with a fixed 8-week dosing interval.
In PULSAR, the safety of aflibercept 8 mg also continued to be similar to Eylea through two years and remained consistent with the known safety profile of Eylea. There were no cases of retinal vasculitis, occlusive retinitis or endophthalmitis in the aflibercept 8 mg group. The rate of intraocular inflammation was 1.3% for the aflibercept 8 mg group and 2.1% for the Eylea (aflibercept 2 mg) group. There was no difference in intraocular pressure increase rates compared to Eylea (aflibercept 2 mg) through two years.
The two-year data from the PULSAR and PHOTON study with aflibercept 8 mg are planned for presentation at upcoming scientific congresses in 2023.
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).
Bayer has submitted regulatory applications for aflibercept 8 mg in Europe and additional markets. Aflibercept 8 mg is currently not approved in any country.
About PULSAR and PHOTON
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.
About nAMD
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. Approximately 10-15% of people with AMD will develop the advanced form 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.