MAR 20, 2018
Topline results from a phase 3 trial show that aflibercept effectively reversed nonproliferative diabetic retinopathy (NPDR) progression, according to an announcement by Regeneron Pharmaceuticals.
The double-masked PANORAMA trial enrolled 402 patients who had moderately severe or severe NPDR without diabetic macular edema (DME). Patients were randomized to an observational sham injection group or 1 of 2 aflibercept treatment groups (i.e., 3 or 5 initial monthly doses, followed by an injection every 8 weeks).
At the primary endpoint of 24 weeks, 58% of patients in the aflibercept arms experienced a 2-step or greater improvement from baseline on the Diabetic Retinopathy Severity Scale, compared with 6% in the sham arm. Patients received an average of 4.4 aflibercept injections during that period.
There were no new safety signals in the trial. One case of mild intraocular inflammation occurred in the aflibercept group.
"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. "Patients in the trial continue to be evaluated to determine if Eyelea can prevent progression to neovascular vision-threatening complications or diabetic macular edema. We look forward to sharing one-year results later this year."