Bayer submits Aflibercept 8 mg for regulatory approval in two major retinal eye diseases in EU

The submission is based on positive data from the phase III study, PULSAR, in nAMD and the phase II/III study, PHOTON, in DME. At week 48, both studies met their primary endpoint of non-inferiority in terms of best corrected visual acuity (BCVA) of aflibercept 8 mg with two extended dosing regimens (every 12 and 16 weeks) compared to Eylea (aflibercept 2 mg) dosed every 8 weeks, following initial monthly doses. 77% of nAMD and 89% of DME patients maintained 16-week dosing intervals with aflibercept 8 mg with an average of 5 injections through week 48. In the 12-week dosing groups, 79% of nAMD patients and 91% of DME patients maintained this dosing interval with aflibercept 8 mg with an average of 6 injections through week 48. In these studies, the safety profile of aflibercept 8 mg was consistent with the well-established safety profile of Eylea (aflibercept 2 mg).

“Patients with neovascular age-related macular degeneration and diabetic macular edema rely on continuous treatment to maintain their visual acuity and prevent visual impairment or even blindness – but some struggle with adherence. Therefore, extended treatment intervals meet an important patient need. The pivotal trials show unprecedented durability results of aflibercept 8 mg, while securing comparable visual acuity and a similar safety profile compared to Eylea, which is the gold standard,” said Dr. Christian Rommel, Member of the Executive Committee of Bayer’s Pharmaceutical Division and Head of Research and Development.

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