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Regeneron Reports the US FDA Acceptance of BLA for Priority Review of Aflibercept for Wet Age-Related Macular Degeneration and Diabetic Macular Edema

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Regeneron Reports the US FDA Acceptance of BLA for Priority Review of Aflibercept for Wet Age-Related Macular Degeneration and Diabetic Macular Edema

Shots:

  • 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

Related Post:- Regeneron Report the US FDA Acceptance of BLA for Priority Review of Pozelimab for the Treatment of Ultra-Rare Chaple Disease

Click here to­ read the full press release 

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Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

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