Regeneron announced that Eylea (aflibercept) injection met its 24-week primary endpoint in the Phase 3 PANORAMA trial for the treatment of moderately severe to severe non-proliferative diabetic retinopathy (NPDR).
Eylea, a vascular endothelial growth factor (VEGF) inhibitor, is an intravitreal injection currently approved to treat neovascular (wet) age-related macular degeneration (AMD), macular edema following retinal vein occlusion (RVO), diabetic macular edema (DME), and diabetic retinopathy (DR) in patients with DME.
The PANORAMA trial is a double-masked, randomized, 2-year ongoing trial (N=402) evaluating Eylea for the improvement of moderately severe to severe NPDR without DME vs sham injection. Study patients were randomized to an observational sham injection or 2 Eylea groups initiating with either 3 or 5 monthly doses; at the 1 year mark, dosing every 8 weeks vs. every 16 weeks will be evaluated.
The 2 primary endpoints are evaluating the proportion of patients who experience a 2-step or greater improvement in Diabetic Retinopathy Severity Scale (DRSS) from baseline at 6 months (24 weeks) and 1 year (52 weeks). Secondary endpoints include prevention of neovascular vision-threatening complications (progression to PDR and anterior segment neovascularization) or progression to DME, as well as its impact on other anatomic effects, visual acuity improvement, safety.
Results so far (at week 24) show more than half of patients who received Eylea experienced a 2-step or greater improvement from baseline on the DRSS vs. patients who received a sham injection (58% vs 6%; P<0.0001). No new safety signals were observed in the trial. Mild intraocular inflammation (IOI) was seen in a patient treated with Eylea.
“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, MD, PhD, President and Chief Scientific Officer of Regeneron.
Findings from PANORAMA will be included in a future supplemental Biologics License Application (sBLA) to the Food and Drug Administration (FDA) later in 2018. Also, the data will be submitted for presentation at a future medical meeting.
For more information call (855) 734-3648 or visit Regeneron.com.