Eylea 8 mg Approved in EU
The European Commission has granted marketing authorization in the European Union (EU) for new Eylea 8 mg (aflibercept 8 mg, 114.3 mg/ml solution for injection) for the treatment of wet age-related macular degeneration (AMD) and visual impairment due to diabetic macular edema (DME).
Eylea 8 mg is approved for administration at extended treatment intervals of up to every 4 months, following 3 initial monthly doses. In patients with stable visual outcomes, treatment intervals of up to 5 months may be considered. Eylea 8 mg is the only treatment in the EU that is approved for extended treatment intervals of up to 5 months in wet AMD and DME.
“Eylea 8 mg is an important advancement in retinal care as it provides greater and longer lasting control of the disease. Doctors may extend their patients interval to 4 months, right after 3 initial monthly doses, based on their judgement,” Jean-François Korobelnik, Professor of Ophthalmology and Head of the Department of Ophthalmology at University Hospital of Bordeaux in France and a trial investigator, said in a company news release. “This then does not only mean less eye injections and doctor visits for patients but could also help to mitigate capacity constraints faced in clinical practices in Europe.”
The EU approval is based on positive results from the PULSAR clinical trial in wet AMD and the PHOTON trial in DME. Both studies met their primary endpoint of noninferior best corrected visual acuity (BCVA) changes with aflibercept 8 mg with 12- or 16-week dosing regimens compared to aflibercept 2 mg (Eylea 40 mg/ml) with a fixed 8-week treatment interval at week 48. In these studies, the safety profile of aflibercept 8 mg was consistent with the established safety profile of Eylea (aflibercept 2 mg).
Aflibercept 8 mg was approved by the FDA under the brand name Eylea HD in August 2023. Bayer has submitted regulatory applications for aflibercept 8 mg in additional markets. Aflibercept 8 mg is being jointly developed by Bayer and Regeneron. Regeneron maintains exclusive rights to Eylea (aflibercept 2 mg) and Eylea HD 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 and Eylea 8 mg.
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 3 PULSAR trial in wet AMD and phase 2/3 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 noninferiority in terms of best corrected visual acuity (BCVA) at week 48. The 2-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.