Regeneron Pharmaceuticals has reported positive topline results from the Phase III trial, PANORAMA, which has been designed to evaluate Eylea (aflibercept) injection in comparison with placebo for the treatment of moderately severe to severe non-proliferative diabetic retinopathy (NPDR).
The trial enrolled 402 patients and features three arms including an observational placebo group and two Eylea treatment groups.
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The trial met its 24-week primary endpoint, which involves the examination of the proportion of patients who experience a two-step or greater improvement in Diabetic Retinopathy Severity Scale (DRSS) score from baseline.
During the trial, 58% of Eylea-treated patients were reported to have experienced a two-step or greater improvement from baseline on the DRSS at week 24, compared to 6% patients receiving sham injection.
No new safety signals were reported in the trial. However, one case of mild intraocular inflammation (IOI) was found in a patient treated with Eylea, which is consistent with the rate of IOI seen in previous clinical trials.
Major secondary endpoints of the PANORAMA trial include evaluation of whether Eylea prevents neovascular vision-threatening complications or progression to diabetic macular edema (DME), as well as its impact on other anatomic effects, visual acuity improvement, and safety.
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By GlobalDataRegeneron Pharmaceuticals president and chief scientific officer George Yancopoulos said: “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.
“Patients in the trial continue to be evaluated to determine if Eylea can prevent progression to neovascular vision-threatening complications or diabetic macular edema.”
Regeneron seeks to provide one-year results from the PANORAMA trial later this year.
