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Originally approved in 2011, aflibercept is a vascular endothelial growth factor (VEGF) inhibitor.
Eylea (aflibercept, Regeneron Pharmaceuticals) has been approved by the FDA to treat all stages of diabetic retinopathy (DR) and reduce the risk of blindness.
Aflibercept is a vascular endothelial growth factor (VEGF) inhibitor indicated for the treat of neovascular (wet) age-related macular degeneration, diabetic macular edema (DME) following retinal vein occlusion, diabetic macular edema, and now diabetic retinopathy (in patients with DME).
The drug also decreases the vascular permeability of water into the eye by blocking VEGF-A and placental growth factor.
For patients with diabetic retinopathy and patients with diabetic macular edema, the recommended dose is 2 mg (0.05 mL) administered by intravitreal injection every four weeks for the first five injections, followed by 2 mg (0.05 mL) once every eight weeks.
The new approval is based upon the results of a one-year PANORAMA randomized multicenter controlled Phase 3 trial that included 402 patients investigating the drug’s ability to improve moderately severe to severe nonproliferative diabetic retinopathy (NPDR) without DME.
"With today's FDA approval, EYLEA has once again set a high bar for the treatment of diabetic eye diseases. The PANORAMA trial showed that by one year 20% of untreated patients developed proliferative diabetic eye disease, and EYLEA reduced this risk by 85% to 88% when administered using an every 16-week or eight-week dosing regimen, respectively," said George D. Yancopoulos, MD, PhD, president and chief scientific officer at Regeneron. "In fact, 80% of patients who received the EYLEA eight-week dosing regimen had significant improvement in their diabetic retinopathy."
Eylea is contraindicated for patients with ocular or periocular infection, active intraocular inflammation, and hypersensitivity.
The most common adverse events reported reported during the PANORAMA trial included endophthalmitis and retinal detachment.