Regeneron Pharmaceuticals, Inc., a leading science-based biopharmaceutical company, announced that the US Food and Drug Administration (FDA) has approved Eylea (aflibercept) injection for the treatment of diabetic retinopathy in patients with diabetic macular edema (DME). In 2014, the FDA granted Eylea Breakthrough Therapy designation and Priority Review for the treatment of diabetic retinopathy in patients with DME.
"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, 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 recommended dosage of Eylea in patients with diabetic retinopathy in DME is 2 milligrams (mg) every two months (8 weeks) after five initial monthly injections. Although Eylea may be dosed as frequently as 2 mg every 4 weeks, additional efficacy was not demonstrated when Eylea was dosed every 4 weeks compared to every 8 weeks.
Eylea is available as a single, 2 milligram (mg) strength intravitreal injection for all approved indications. Eylea was previously approved in the US for the treatment of wet age-related macular degeneration (AMD), macular edema following retinal vein occlusion (RVO), and diabetic macular edema (DME).
The approval of Eylea for the treatment of diabetic retinopathy in DME was based on two year data from the phase 3 VISTADME and VIVID-DME studies of 862 patients, which compared Eylea 2 mg monthly, Eylea 2 mg every two months (after five initial monthly injections), or macular laser photocoagulation (at baseline and then as needed). In these studies, on the primary endpoint of mean change in Best Corrected Visual Acuity (BCVA) at one year, patients treated with Eylea monthly or every two months showed statistically significant improvements compared to the control group. Patients in both Eylea groups gained, on average, the ability to read approximately two additional lines on an eye chart compared with almost no change in the control group.
A pre-specified secondary endpoint in the studies at year 2 evaluated diabetic retinopathy severity based on an established grading scale measuring retinal damage. In the VISTA-DME trial, 38 per cent of patients receiving Eylea monthly or every two months (after 5 initial monthly injections) achieved a 2-step or better improvement on the diabetic retinopathy severity scale (DRSS), compared to 16 per cent of patients receiving control. In the VIVID-DME trial, approximately 30 per cent of patients receiving Eylea monthly or every two months (after 5 initial monthly injections) achieved a 2-step or better improvement on the DRSS, compared to 8 per cent of patients receiving control.
In these trials at year 2, Eylea had a similar overall incidence of adverse events (AEs), ocular serious AEs, and non-ocular serious AEs across treatment groups and the control group. Arterial thromboembolic events as defined by the Anti-Platelet Trialists' Collaboration (non-fatal stroke, non-fatal myocardial infarction, and vascular death) also occurred at similar rates across treatment groups and the control group. The most frequent ocular treatment emergent AEs (TEAEs) observed in the VISTA-DME and VIVID-DME trials included conjunctival hemorrhage, eye pain, cataract, and vitreous floaters. The most common non-ocular TEAEs included hypertension and nasopharyngitis, which occurred with similar frequency in the treatment groups and the control group.
Diabetic retinopathy is a common complication of diabetes, causing damage to the retina, which may lead to poor vision and vision loss. Over time, patients with diabetic retinopathy are at risk of experiencing vision-threatening events. These include DME, which refers to swelling of the macula (the part of the retina responsible for central, fine vision) and progression to proliferative diabetic retinopathy, which often results in profound visual loss due to complications including vitreous hemorrhage and/or tractional retinal detachment. DME is the most frequent cause of vision loss in patients with diabetes and eventually can lead to blindness.
Vascular endothelial growth factor (VEGF), a naturally occurring family of growth factors in the body, appears to play a critical role in the development of diabetic retinopathy and, subsequently, DME. Increased VEGF production contributes to the vascular disruptions associated with diabetic retinopathy and the subsequent leakage that characterizes DME, as well as the formation of new blood vessels (a process known as angiogenesis).
Eylea is a vascular endothelial growth factor (VEGF) inhibitor formulated as an injection for the eye. Eylea is designed to block 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 (PLGF), two growth factors involved in angiogenesis. Eylea helps prevent VEGF-A and PLGF from interacting with their natural VEGF receptors as shown in preclinical studies.
Regeneron is a leading science-based biopharmaceutical company based in Tarrytown, New York that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions.