Regeneron Pharmaceuticals has reported positive two-year data of Eylea (aflibercept) from the Phase III PANORAMA clinical trial in patients with moderately severe to severe non-proliferative diabetic retinopathy (NPDR).
The exploratory results showed that if left untreated, NPDR could result in vision-threatening events such as vision-threatening complications (VTCs) and centre-involved diabetic macular oedema (CI-DME).
A Kaplan-Meier analysis found 58% of patients in the untreated group developed a VTC or CI-DME within two years of enrolment in the trial.
Meanwhile, Eylea treatment was shown to decrease the risk of these vision-threatening events by at least 75%.
PANORAMA investigator Charles Wykoff said: “These data reinforce that regular Eylea treatment can be highly effective at reducing the risk of new vision-threatening events among patients with moderately severe to severe non-proliferative diabetic retinopathy.
“The PANORAMA trial shows that more than half of all untreated patients developed vision-threatening events over two years, underscoring the value of treating patients proactively and regularly.”
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According to the two-year data, a greater benefit was observed in patients treated with Regeneron’s drug at regular intervals versus those on less frequent treatment with the drug.
Adverse events during the trial were consistent with the known profile of the drug.
PANORAMA is a randomised, multi-centre, controlled trial conducted to compare Eylea to sham injection for the improvement of moderately severe to severe NPDR without DME in 402 patients.
The US Food and Drug Administration (FDA) approved the drug for diabetic retinopathy treatment based on six-month and one-year data from this Phase III trial.
Last month, Regeneron reported positive data from the LUMINA-1 trial of garetosmab (REGN2477) for fibrodysplasia ossificans progressiva (FOP), a very rare bone disease.