FDA expanded approval of aflibercept injection to treat diabetic retinopathy

March 25, 2015

FDA has expanded the approval of aflibercept (Eylea, Regeneron) injection to treat diabetic retinopathy in patients with macular edema.

FDA has expanded the approval of aflibercept (Eylea, Regeneron) injection to treat diabetic retinopathy in patients with macular edema.

Diabetic retinopathy (DR) is a disorder of the retinal vasculature that occurs in patients with long-standing diabetes. Diabetic retinopathy is the most common diabetic eye disease and a leading cause of blindness in American adults.  Ocular neovascularization, or the growth of new abnormal blood vessels on the surface of the retina, may occur in some cases of DR in patients with diabetic macular edema (DME) which can cause vision loss and eventual blindness. 

Related:FDA approves Lucentis for treatment of diabetic retinopathy in people with DME

Elyea is a recombinant fusion protein that acts as a decoy receptor that binds vascular endothelial growth factor- A (VEGF-A) and placental growth factor (PIGF) to prevent binding and activation of their respective receptors. VEGF-A and PIGF are members of the VEGF family of angiogenic factors that play an important role in the permeability and growth of new blood vessels. Inhibiting the binding of VEGF-A and PIGF to their receptors suppresses neovascularization in the eye and slows vision loss.

Read more: FDA drug approvals

Eylea is administered by a trained physician as an injection into the eye once a month for the first 5 injections and then once every 2 months. It is intended to be used along with appropriate interventions to control blood pressure, cholesterol and blood glucose.

"Diabetic retinopathy coupled with DME is a serious complication of diabetes that can threaten the vision of many working-age adults," said George D. Yancopoulos, M.D., Ph.D., Chief Scientific Officer of Regeneron and President of Regeneron Laboratories. "In addition to improving visual acuity in people with DME,Eylea also improves these patients' retinal vessel damage, or retinopathy. Eylea is the only treatment option for diabetic retinopathy in patients with DME that is approved for less than monthly dosing after an initial monthly dosing period."

The expanded approval of Eylea is based on 2 clinical trials with 679 participants in which patients were randomly assigned to receive Eylea or macular laser photocoagulation, a laser-based treatment used to burn small areas of the retina. Results showed that participants treated with Eylea showed significant improvement in the severity of their DR compare to the laser-treated group.

Eylea was previously approved to treat wet (neovascular) age-related macular degeneration as well as for the treatment of DME and macular edema secondary to retinal vein occlusions. The most common side effects associated with the use of Eylea include bleeding of the conjunctiva, eye pain, cataracts, floaters, increased intraocular pressure, and vitreous detachment. 

Read next: DME study: Aflibercept injection shows greater gains in visual acuity than alternative anti-VEGF therapies