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.

Anatomic outcomes (secondary endpoints) were also investigated in the clinical trials: all aflibercept 8 mg arms demonstrated superior fluid control in nAMD and robust disease control with 12- and 16-week dosing in nAMD and DME versus Eylea (aflibercept 2 mg) through to week 48. Similar reductions in mean change of central retinal thickness (CRT) were achieved in nAMD and DME patients receiving aflibercept 8 mg with 12- and 16-week dosing versus Eylea (aflibercept 2 mg) with 8-week dosing at week 48.

The safety of aflibercept 8 mg in both trials was similar to the well-established safety profile of Eylea (aflibercept 2 mg) and consistent with previous clinical trials. The rates of intraocular inflammation (IOI) for aflibercept 8 mg compared to Eylea (aflibercept 2 mg) were 0.7% versus 0.6% in PULSAR and 0.8% versus 0.6% in PHOTON. No severe cases of IOI were observed. There were no clinically relevant differences in intraocular pressure between the treatment groups. In both trials, there were no cases of endophthalmitis, retinal vasculitis and no new safety signals through week 48.

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 evaluated by any regulatory authority.