The US FDA Accepts sBLA Priority Review for Regeneron's EYLEA HD in Macular Edema Following RVO and Monthly Dosing In Approved Indications
Shots:
- Regeneron reported the US FDA acceptance for its priority review of the sBLA by using priority review voucher for EYLEA HD (aflibercept 8 mg) to treat macular edema from retinal vein occlusion (RVO) and to expand dosing to include monthly administration in all approved indications. The US FDA’s expected action date is Aug 19, 2025
- The sBLA was supported by the data from across the EYLEA HD clinical program, including the P-III (QUASAR) study investigating EYLEA HD in RVO
- In P-III (QUASAR) study, patients received EYLEA HD Q8W after 3 or 5 initial monthly doses, or EYLEA Q4W. The study met its 1EP (change in best corrected visual acuity) at week 36 measured by the Early Treatment Diabetic Retinopathy Study letter score
Ref: Regeneron | Image: Regeneron
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