Biotech Values

[iwfal]

If the trial design were up to me, I would try to show non-inferiority to on-label Eylea treatment rather than superiority to a patently substandard regimen.

Given that in the real world patients generally do NOT go back for retreatment per label (the disease stabilizes to a significant degree for many, and the treatment is unpleasant), the assumptions by OCUL and FDA are that:

A) the trial does actually mimic what happens IRL for many patients

B) that the two treatments don’t materially differ wrt efficacy prior to winding down.