Shots:
- FDA has approved extending Eylea HD dosing intervals up to 20wks. for wet age-related macular degeneration (wAMD) & diabetic macular edema (DME) after 1yr. of response based on visual & anatomic outcomes
- As a part of approval, the Eylea HD label will incl. 96wk. PULSAR (wAMD; n=583) & PHOTON (DME; n=395) data, where 71% wAMD & 72% DME pts attained the last assigned dosing intervals of ≥16wks., while 47% wAMD & 44% DME pts achieved ≥20wks. interval
- Additionally, the FDA has set a PDUFA target action date of Apr 2026 for the Eylea HD prefilled syringe under a CMC prior-approval supplement review
Ref: Globenewswire | Image: Regeneron | Press Release
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