Regeneron Pharmaceuticals, Inc. announced positive two-year results from the Phase 3 PANORAMA trial evaluating EYLEA® (aflibercept) in patients with moderately severe to severe non-proliferative diabetic retinopathy (NPDR). The data were presented for the first time at the Angiogenesis, Exudation, and Degeneration 2020 meeting in Miami, Florida.
PANORAMA is a randomized, multi-center, controlled Phase 3 trial enrolling 402 patients that was designed to investigate EYLEA for the improvement of moderately severe to severe NPDR without DME, compared to sham injection. NPDR is caused by microvascular damage to the blood vessels in the retina often caused by poor blood sugar control in people with diabetes. It may progress to a stage of the disease in which abnormal blood vessels grow onto the surface of the retina. PANORAMA is the first prospective trial to study whether vascular endothelial growth factor (VEGF) inhibition can also help prevent worsening disease in patients with NPDR without DME.
EYLEA® (aflibercept) injection 2 mg (0.05 mL) 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.
Two-year data trial data showed that EYLEA treatment was shown to reduce the likelihood of vision-threatening events, including vision-threatening complications (VTCs; proliferative diabetic retinopathy or anterior segment neovascularization). Meanwhile, 58% of patients in the untreated sham arm developed a VTC or CI-DME within two years of entering the trial.
"These data reinforce that regular EYLEA treatment can be highly effective at reducing the risk of new vision-threatening events among patients with moderately severe to severe non-proliferative diabetic retinopathy," said Charles C. Wykoff, M.D., Ph.D., PANORAMA investigator, retina surgeon and ophthalmologist with Retina Consultants of Houston. "The PANORAMA trial shows that more than half of all untreated patients developed vision-threatening events over two years, underscoring the value of treating patients proactively and regularly."
Also presented today was the rationale for high-dose (8 mg) aflibercept clinical trials. A Phase 2 trial (CANDELA) evaluating high-dose aflibercept in wet age-related macular degeneration (wet AMD) is currently enrolling. Phase 3 trials planned to start in 2020 in wet AMD (PULSAR, sponsored by Bayer) and DME (PHOTON, sponsored by Regeneron) will evaluate dosing intervals of 12 weeks and longer.
Full news release: https://newsroom.regeneron.com/index.php/news-releases/news-release-details/eylear-aflibercept-injection-reduced-risk-developing-vision
Source: Regeneron Pharmaceuticals