By: Sylva Ohanian, Staff Writer
The FDA recently approved aflibercept (Eylea®) injection for the treatment of diabetic retinopathy (DR) in patients with diabetic macular edema (DME).1
Diabetic retinopathy is the most common diabetic eye disease and is a leading cause of blindness in American adults. It is generally characterized by changes occurring in the blood vessels of the retina. In some instances of DR, diabetic macular edema ensues, which is when blood vessels swell up and leak fluid, and new blood vessels may grow on the surface of the retina. Vision loss may occur in some patients as a result of DR, especially if left untreated.1,2 Aflibercept works by acting as a soluble decoy receptor that binds vascular endothelial growth factor-A (VEGF-A) and placental growth factor (PLGF), thereby inhibiting effects of vascular permeability and neovascularization.3
The FDA granted aflibercept breakthrough therapy designation for the treatment of DR in patients with DME. Breakthrough therapy designation is assigned if preliminary clinical evidence indicates that a drug displays considerable improvement over current therapies for patients with a serious or life-threatening condition. Once designated, the drug undergoes expedited development and review by the agency. Requests for breakthrough therapy are assessed and approved or rejected within 60 days of receipt.4
Preliminary evidence for aflibercept included two clinical studies where 679 participants were randomly assigned to receive aflibercept injections or macular laser photocoagulation, a laser-based procedure that burns areas of the retina. Compared to patients who did not receive aflibercept, patients receiving aflibercept at week 100 showed significant improvement in the severity of the disease.1
The recommended dose for DR with DME is 2 mg (0.05 mL or 50 microliters) administered by intravitreal injection every month for the first five injections, followed by 2 mg (0.05 mL) once every 2 months. The manufacturer notes, “Although Eylea® may be dosed as frequently as 2 mg every 4 weeks (monthly), additional efficacy was not demonstrated when Eylea® was dosed every 4 weeks compared to every 8 weeks.”3
Common side effects associated with the use of this product include conjunctival hemorrhage, eye pain, cataracts, vitreous floaters, vitreous detachment, and increased intraocular pressure.3 Serious side effects include endophthalmitis and retinal detachments.1
The recent approval of aflibercept for the treatment of DR with DME will allow doctors and patients to make appropriate and informed treatment decisions for diabetic retinopathy.
- FDA approves new treatment for diabetic retinopathy in patients with diabetic macular edema. U.S. Food and Drug Administration. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm439838.htm. Updated 03/27/2015. Accessed 06/02/15.
- Facts about diabetic eye disease. National Eye Institute. https://www.nei.nih.gov/health/diabetic/retinopathy. Updated 06/2012. Accessed 06/02/15.
- Eylea [package insert]. Tarrytown, NY: Regeneron Pharmaceuticals, Inc.; Revised 03/2015.
- Fact sheet: breakthrough therapies. U.S. Food and Drug Administration. http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/SignificantAmendmentstotheFDCAct/FDASIA/ucm329491.htm. Updated 12/10/2014. Accessed 06/02/15.