FDA approves Eylea for treatment of DME
- The FDA has approved Eylea (aflibercept) for treatment of diabetic macular edema (DME), PharmaTimes reports.
- Eylea is now the first available VEGF inhibitor designed to be administered less than once a month.
- The regulatory approval is based on one-year, phase III data showing significant improvement in best-corrected visual acuity (BCVA).
Earlier this month, Biopharma Dive reported on positive phase III data from the VIVID-DME trial, comparing Eylea injection therapy with photocoagulation in DME patients. In the study, Eylea-treated patients with DME had an average BCVA gain of 11.4 letters -- or about two full lines on an eye exam chart.
Eylea is the first VEGF inhibitor with a bimonthly dosing schedule. It will compete with Lucentis (ranibizumab) from Genentech/Roche, as well as Roche’s Avastin (bevacizumab), which is increasingly used off-label for treatment of DME. The overall consensus is that Eylea is a blockbuster in the making.
- Pharma Times Third US OK for Regeneron’s Eylea