Medication Monitor

Generic Name (Trade Name—Company)
June 12, 2019


Aflibercept approved to treat all stages of diabetic retinopathy

Regeneron announced FDA approval of aflibercept injection to treat all stages of diabetic retinopathy (DR) and thereby reduce the risk of blindness.

The vascular endothelial growth factor (VEGF) inhibitor blocks the growth of new blood vessels and decrease the ability of fluid to pass through blood vessels (vascular permeability) in the eye by blocking VEGF-A and placental growth factor, two growth factors involved in angiogenesis. 

The agent was approved with two dosing options for DR: every 8 weeks following five initial monthly injections, or every 4 weeks.

Approval of aflibercept as a treatment for DR was based on 6-month and 1-year results from PANORAMA, a randomized, multicenter, controlled Phase III trial that enrolled 402 patients. The trial was designed to investigate whether aflibercept improved moderately severe to severe NPDR without diabetic macular edema (DME), compared with a placebo injection. 

The most common adverse reactions (≥5%) were conjunctival hemorrhage, eye pain, cataract, vitreous detachment, vitreous floaters, and increased intraocular pressure.