Regeneron Pharmaceuticals announced the Phase 3 PANORAMA trial evaluating EYLEA (aflibercept) Injection in moderately severe to severe non-proliferative diabetic retinopathy (NPDR) met its 24-week primary endpoint. In the trial, 58 percent of EYLEA-treated patients experienced a two-step or greater improvement from baseline on the Diabetic Retinopathy Severity Scale (DRSS) at week 24, compared to 6 percent of patients receiving sham injection (p<0.0001).
"This is the first time a therapy has demonstrated it can reverse disease progression in patients with moderately severe to severe non-proliferative diabetic retinopathy without diabetic macular edema, in a trial specifically designed to study this population," said George D. Yancopoulos, M.D., Ph.D., President and Chief Scientific Officer of Regeneron. "Patients in the trial continue to be evaluated to determine if EYLEA can prevent progression to neovascular vision-threatening complications or diabetic macular edema. We look forward to sharing one-year results later this year."
Patients in the active treatment groups received, on average, 4.4 EYLEA injections during the first 24 weeks. There were no new safety signals in the trial. There was one case of mild intraocular inflammation (IOI) in a patient treated with EYLEA (0.085 percent rate per injection), which is consistent with the rate of IOI seen in previous clinical trials.
Approximately eight million people live with diabetic retinopathy, a disease characterized by microvascular damage to the blood vessels in the retina often caused by poor blood sugar control in people with diabetes. The disease starts as NPDR and generally has no warning signs or symptoms. Approximately 560,000 people live with moderately severe to severe NPDR without DME in the U.S. As NPDR becomes more severe, DME can occur as the blood vessels in the retina become increasingly fragile and leak fluid, potentially causing visual impairment. NPDR may also progress to PDR, a stage of the disease in which abnormal blood vessels grow onto the surface of the retina and potentially cause severe, vision-threatening complications such as vitreous hemorrhage and traction retinal detachment.
EYLEA (aflibercept) Injection is a vascular endothelial growth factor (VEGF) inhibitor formulated as an injection for the eye. It 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. In the U.S., EYLEA is the market-leading, FDA-approved anti-VEGF treatment for its approved indications and is supported by a robust body of research that includes seven pivotal Phase 3 trials.