FDA Approves Aflibercept Injection Treatment for Retinal Conditions

The US Food and Drug Administration (FDA) has approved the Chemistry, Manufacturing and Controls (CMC) Prior-Approval Supplement (PAS) for the EYLEA (aflibercept) Injection prefilled syringe to treat 4 retinal conditions.

The approval is for a 2 mg, single-dose, sterilized prefilled syringe produced by Regeneron Pharmaceuticals that enables physicians to administer EYLEA with fewer preparation steps than vials.

“With 8 pivotal phase 3 trials and millions of injections used around the world, EYLEA sets a high bar for visual acuity and safety across multiple retinal diseases, including wet age-related macular degeneration and diabetic eye diseases,” George D. Yancopoulos, MD, PhD, President and Chief Scientific Officer of Regeneron, said in a statement. “This approval may help doctors more conveniently and efficiently deliver EYLEA to appropriate patients.”

Regeneron is expected to make the treatment available at some point this year as a sterilized prefilled syringe for EYLEA, which has been used to treat neovascular (wet) age-related macular degeneration, macular edema following retinal vein occlusion (RVO), diabetic macular edema (DME), and diabetic retinopathy (DR).

EYLEA Injection is a vascular endothelial growth factor (VEGF) inhibitor formulated as an injection for the eye, designed to block the growth of new blood vessels and decrease the ability for fluid to pass through blood vessels in the eye by blocking VEGF-A and placental growth factor (PLGF), 2 growth factors involved in angiogenesis.

Intravitreal injections have been associated with endophthalmitis and retinal detachments and acute increases in intraocular pressure has been seen within 60 minutes of intravitreal injection.

The treatment also comes with a potential risk of arterial thromboembolic events, such as a nonfatal stroke, nonfatal myocardial infarction, or vascular death.

The incidence of reported thromboembolic events in wet AMD studies during the first year was 1.8% (32 out of 1824) in the combined group of patients treated with EYLEA compared with 1.5% (9 out of 595) in patients treated with ranibizumab. Through 96 weeks, the incidence was 3.3% (60 out of 1824) in the EYLEA group compared with 3.2% (19 out of 595) in the ranibizumab group.

The incidence in the DME studies from baseline to week 52 was 3.3% (19 out of 578) in the combined group of patients treated with EYLEA compared with 2.8% (8 out of 287) in the control group.

From baseline to week 100, the incidence was 6.4% (37 out of 578) in the combined group of patients treated with EYLEA compared with 4.2% (12 out of 287) in the control group. There were no reported thromboembolic events in the patients treated with EYLEA in the first six months of the RVO studies.