Regeneron's Eylea nabs yet another FDA approval for expanded label
- The FDA has approved use of Eylea (aflibercept) injection for treatment of diabetic retinopathy (DR) in patients with diabetic macular edema (DME).
- DR is the most common diabetic eye disease and the leading cause of blindness in the U.S.
- Roche/Genentech's Lucentis (ranizumab) received approval for the same indication in February.
In addition to its latest indication, Eylea is also FDA-approved for the treatment of wet age-related macular degeneration (AMD), as well as DME and macular edema secondary to retinal vein occlusions. In the randomized study that led to the latest approval, Eylea-treated patients showed significant improvement in the severity of DR, compared with photocoagulation-treated patients.
Patients with DME, who are being treated for DR, receive an injection from their physician once a month for the first five injections, and then once every two months. However, these patients must also be treated for hyperglycemia, as well as hypercholesterolemia and hypertension, if needed.