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Aflibercept Injection Approved for Diabetic Retinopathy
Regeneron Pharmaceuticals, Inc. has received FDA approval for EYLEA® (aflibercept) Injection for all stages of diabetic retinopathy (DR), thus reducing the risk of blindness.
Approximately eight million people live with DR, the main cause of blindness in working-aged U.S. adults. The disease usually begins as non-proliferative diabetic retinopathy (NPDR) and frequently has no warning signs or symptoms. Eventually, NPDR can progress to proliferative diabetic retinopathy (PDR), and possible severe vision loss.
Aflibercept is the only vascular endothelial growth factor (VEGF) inhibitor approved with two dosing options for DR: every eight weeks (after five initial monthly injections) or every four weeks. This enables doctors to customize their patients’ treatment.
Aflibercept injection is designed to block new blood vessel growth and decrease vascular permeability in the eye by blocking VEGF-A and placental growth factor (PLGF), which are involved in angiogenesis.
The approval was based on results from the randomized, multicenter, controlled, phase 3 PANORAMA trial with 402 patients. The trial was designed to investigate aflibercept for the improvement of moderately severe to severe NPDR without diabetic macular edema (DME), compared to sham injection. PANORAMA is the first prospective trial to study whether an anti-VEGF inhibitor can also help prevent worsening disease in patients with NPDR without DME.
At one year, 65% of patients showed ≥ 2-step improvement in the diabetic retinopathy severity scale (DRSS) from baseline with the once-every-16-weeks regimen, and 80% of patients showed improvement on the once-every-8-weeks regimen.
The most common adverse reactions in patients receiving aflibercept were conjunctival hemorrhage, eye pain, cataract, vitreous detachment, vitreous floaters, and increased intraocular pressure.
Source: Regeneron, May 13, 2019