Not intended for U.S. and UK Media
Berlin, June 29, 2023 – Bayer today announced the two-year (96 weeks) topline results of the pivotal clinical trial PHOTON investigating its novel aflibercept 8 mg with extended dosing regimens of up to 24 weeks in diabetic macular edema (DME) compared to the current standard of care EyleaTM (aflibercept 2 mg) with fixed intervals of 8 weeks. The two-year results reinforce the long-term efficacy and safety and the unprecedented durability of aflibercept 8 mg in patients with DME.
At two years (96 weeks), the aflibercept 8 mg groups demonstrated that 89% of patients maintained a ≥12-week dosing interval, compared to 93% through one year (48 weeks). A considerable number of patients met the extension criteria for dosing intervals greater than every 16 weeks, including 43% reaching ≥20-week intervals and 27% reaching 24-week intervals.
Of those randomized to a 16-week dosing regimen at baseline, 83% maintained ≥16-week dosing intervals through two years, compared to 89% maintaining a 16-week dosing interval through one year. This group received at 96 weeks 6 fewer injections into the eye, down to a mean number of 7.8 injections versus 13.8 injections with Eylea (aflibercept 2 mg) at fixed 8-weekly dosing. At the same time, extended treatment intervals with aflibercept 8 mg achieved sustained vision gains and safety similar to standard of care Eylea (aflibercept 2 mg).
“We are excited to see that aflibercept 8 mg allowed an unprecedented proportion of patients to be extended to treatment intervals of up to 24 weeks during two years of treatment with outcomes that were consistent with the Eylea 2 mg comparator arm,” said Sobha Sivaprasad, Professor and Consultant Ophthalmologist, Moorfields Eye Hospital, London, UK, and member of the steering committee of the PHOTON study. “These clinically important results show that the burden of disease can be reduced for many more patients in the future contributing to improved adherence and thus better patient outcomes.”
“Diabetic macular edema is a leading cause of vision loss, and we are fully committed to support patients with extended treatment intervals to alleviate their disease burden,” said Dr. Christian Rommel, Member of the Executive Committee of Bayer’s Pharmaceuticals Division and Head of Research and Development. “The current data underline that aflibercept 8 mg provides sustained disease control with greater and longer-lasting control of the underlying disease compared to Eylea in a fixed dosing regimen.”
The pivotal clinical trial PHOTON has shown that aflibercept 8 mg met its primary endpoint achieving non-inferior improvements in best corrected visual acuity (BCVA) with extended treatment intervals of up to every 12 or 16 weeks following 3 initial monthly doses, compared to Eylea (aflibercept 2 mg) dosed every 8 weeks following 5 initial monthly doses, throughout the first year of treatment. Now, the two-year data reinforce the efficacy, safety, and durability of aflibercept 8 mg in DME with extended dosing intervals.
In the trial, patients randomized at baseline to receive 12- or 16-week dosing regimens, after only three initial monthly loading doses, were able to shorten or extend to longer dosing intervals in the second year without compromising vision if pre-specified criteria were met.
The safety profile of aflibercept 8 mg was similar to the well-established safety profile of Eylea and consistent with the safety observed in previous clinical trials.
The two-year data from the PULSAR study of aflibercept 8 mg in nAMD are expected during the second half of 2023 and both data sets are planned for presentation at an upcoming scientific congress in 2023.
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 outside of the U.S.
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. 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.
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 is affecting around 21 million people globally.
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