Kodiak’s KSI-301 Has Narrower Path Forward After Phase II/III Failure In Wet AMD
Monthly dosing remains a possibility in wet age-related macular degeneration, though diabetic macular edema and retinal vein occlusion look more promising.
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There are concerns that even with better efficacy and dosing versus Eylea and biosimilars, payers may impose step-edits on Regeneron’s new high-dose version.
Roche’s bispecific antibody, to be called Vabysmo, has got US approval for wet age-related macular degeneration and diabetic macular edema, markets where Bayer and Regeneron's Eylea is a huge seller. The Swiss company hopes that its less-frequent dosing advantage and a price that offers savings over time will make an impact on the market.
An analyst had suggested that in the event of a thumbs-down from the FDA, the company could end up focusing on other catalysts instead.