Aflibercept 8 mg recommended by CHMP for approval in the EU

This includes injections with aflibercept 8 mg at extended treatment intervals of up to every 4 months, after 3 initial monthly doses. In patients with stable visual outcomes, treatment intervals of up to 5 months may be considered. Once approved, aflibercept 8 mg will be the only approved drug providing extended treatment intervals of up to 5 months, based on results in clinical trials, for patients with nAMD and DME.

The CHMP recommendation is based on positive results from the PULSAR clinical trial in nAMD and the PHOTON trial in DME. Both studies met their primary endpoint of non-inferior best corrected visual acuity (BCVA) changes with aflibercept 8 mg with 12- or 16-week dosing regimens compared to Eylea (aflibercept 2 mg) with a fixed 8-week treatment interval at week 48.

“The clinical trials with aflibercept 8 mg have demonstrated sustained vision gains with extended treatment intervals, rapid and resilient fluid control, and a comparable safety profile to Eylea 2 mg. This concept of sustained disease control has been eagerly anticipated, because greater and longer lasting control of disease activity is needed to alleviate disease burden for patients and capacity constraints at eye clinics and ophthalmologists’ offices,” said Prof. Paolo Lanzetta, Chairman of the Department of Ophthalmology at the University of Udine, Italy, and a member of the steering committee of the clinical trials. “This can contribute to improved patient adherence and persistence, and support physicians to free up resources to help more patients.”