Regeneron Reports the US FDA Acceptance of BLA for Priority Review of Aflibercept for Wet Age-Related Macular Degeneration and Diabetic Macular Edema
- The US FDA has accepted the BLA for Priority Review of aflibercept for wAMD, DME & diabetic retinopathy. The FDA’s decision is expected in June 2023, following the use of a priority review voucher
- The BLA was based on the (PULSAR) trial in wAMD and (PHOTON) trial in DME evaluating aflibercept (8mg) vs Eylea. Both trials met their 1EPs of non-inferiority in vision gains for 12 & 16wk. dosing regimens after initial monthly doses @48wks., patients were able to maintain the 12 & 16wk. dosing regimens (79% & 77% in wAMD) & (91% & 89% in DME)
- The safety profile was similar to Eylea & consistent with the known safety profile of Eylea from prior trials, ocular AEs in both trials (31% vs 28%) & (38% vs 39%) with no cases of retinal vasculitis, occlusive retinitis or endophthalmitis
Ref: GlobeNewswire | Image: Regeneron
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