Regeneron’s Eylea smashes Phase 3 trial goal in diabetic retinopathy
pharmafile | March 20, 2018 | News story | Manufacturing and Production, Research and Development | Eylea, Regeneron, diabetes, pharma
Regeneron has confirmed that its vascular endothelial growth factor (VEGF) inhibitor injection Eylea (aflibercept) met its primary endpoint in a recent Phase 3 study, showing strong results in the treatment of moderately severe to severe non-proliferative diabetic retinopathy (NPDR).
In the ongoing 402-participant trial, patients were randomised to receive either Eylea or placebo, with two treatment arms for the former and one for the latter. It was found that, after 24 weeks of treatment, 58% of patients taking Eylea showed a two-step or greater improvement from baseline according to the Diabetic Retinopathy Severity scale (DRRS), meeting the study’s primary endpoint. By comparison, only 6% of patients administered with placebo achieved the same improvement.
“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,” explained George Yancopoulos, Regeneron’s President and Chief Scientific Officer. “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.”
The study will continue until the two-year mark. Participant DRSS scores will be measured again at 52 weeks to assess whether the study meets its second primary endpoint.
Diabetic retinopathy is characterised by microvascular damage to the retina’s blood vessels, often due to poor control of blood sugar in diabetes patients. It is estimated that around eight million people live with the condition worldwide.
Matt Fellows
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