Bayer gains added MHRA nods for Eylea in the treatment of macular diseases

German pharma major Bayer (BAYN: DE) today revealed that it has received authorization from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) for Eylea (aflibercept) 8mg in adults for the treatment of neovascular (wet) age-related macular degeneration (nAMD), and visual impairment due to diabetic macular oedema (DMO).

Though already facing competition from biosimilars, Bayer's third-quarter 2023 sales of Eylea were 802 million euros ($873 million), a modest 1% decline on the like, 2022 period. The drug was developed in partnership with US biotech Regeneron (Nasdaq: REGN).

The authorization is based on positive data from the Phase III study, PULSAR, in nAMD and the Phase II/III study, PHOTON, in DMO. The Phase III PULSAR and Phase II/III PHOTON studies compared aflibercept 8mg with a lower 2mg dose in patients with nAMD and DMO respectively. At week 48, both studies met their primary endpoint of non-inferiority in terms of best corrected visual acuity (BCVA) of aflibercept 8mg with two extended dosing regimens (every 12 and 16 weeks) compared to aflibercept 2mg dosed every eight weeks following initial monthly doses.