High-dose Eylea rejection leaves Vabysmo unopposed

The good news for Regeneron is that high-dose Eylea, key to wresting more value from its golden goose, was only rejected by the FDA because of issues with a third party manufacturer. The bad news was that it was rejected at all. Approval of the 8mg dose for three indications – wet age-related macular degeneration, diabetic macular oedema and diabetic retinopathy – had been widely expected; Cowen analysts write that “the CRL is an annoyance for sure,” but believe the approval will not be delayed more than three months. But that is bad enough. The knockback will benefit Roche, whose bispecific Vabysmo will continue to gain share from low-dose Eylea uncontested until the high-dose form is launched. Both Vabysmo and high-dose Eylea can be administered as infrequently as every four months in wet AMD. Regeneron also released further data from the Photon trial of high-dose Eylea in diabetic macular oedema, showing that of those assigned to a 16-week dosing regimen, 83% maintained dosing intervals of four months or longer for two years. 43% met the extension criteria for five month or longer intervals and 27% for six-month intervals. This data could give Eylea an edge on Vabysmo – eventually.