Eylea meets first endpoint in phase 3 nonproliferative diabetic retinopathy trial
The phase 3 PANORAMA trial of Eylea in patients with moderately severe to severe nonproliferative diabetic retinopathy met its 24-week endpoint, according to a press release from Regeneron.
At week 24, 58% of patients treated with Eylea (aflibercept) injection experienced a two-step or greater improvement from baseline on the Diabetic Retinopathy Severity Scale compared with 6% of patients who received a sham injection (P < .0001), the release said.
“This is the first time a therapy has demonstrated it can reverse disease progression in patients with moderately severe to severe nonproliferative diabetic retinopathy without diabetic macular edema, in a trial specifically designed to study this population,” George Yancopoulos, MD, PhD, president and chief scientific officer of Regeneron, said in the release.
The ongoing, pivotal, double-masked, randomized, 2-year trial is evaluating three treatment arms: a sham injection group and two Eylea treatment groups that receive either three or five initial monthly doses. Those in the active treatment groups received an average of 4.4 Eylea injections within the first 24 weeks, the release said.
One-year results from the trial, the second primary endpoint, should be released later in 2018. Study results are expected to be used for a supplemental biologics license application to the FDA this year, the release said.