Regeneron Pharmaceuticals said that a phase 3 trial assessing Eylea (aflibercept) Injection 2 mg (0.05 mL) in moderately severe to severe non-proliferative diabetic retinopathy (NPDR) has yielded positive two-year results.
The late-stage trial called PANORAMA, which features 402 patients, has been assessing Eylea in comparison to sham injection for the improvement of moderately severe to severe NPDR without diabetic macular edema (DME).
According to Regeneron, the two-year pre-specified exploratory data showed that moderately severe and severe NPDR when left untreated can result in vision-threatening events, which includes vision-threatening complications and centre-involved diabetic macular edema (CI-DME).
The company said that in the untreated sham arm, 58% of patients developed vision-threatening complications or CI-DME within two years of joining the PANORAMA trial. The findings were based on a Kaplan-Meier analysis, said Regeneron.
In contrast, Eylea was shown to have brought down the risk of developing vision-threatening events by 75% after two years of treatment.
PANORAMA trial 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.”
Eylea, which is a vascular endothelial growth factor (VEGF) inhibitor, was approved by the US Food and Drug Administration (FDA) in May 2019 for the treatment of diabetic retinopathy. The FDA approval was based on the six-month and one-year data from the PANORAMA trial.
The VEGF inhibitor is also approved in the US for wet age-related macular degeneration (AMD), macular edema following retinal vein occlusion (RVO), and DME.
Regeneron president and chief scientific officer George Yancopoulos said: “Through millions of injections and eight pivotal Phase 3 trials, Eylea has built a substantial body of evidence and safety profile.
“High-dose aflibercept will hopefully build on this standard-of-care therapy and represents our ongoing commitment to ophthalmologic research and development.”
The VEGF inhibitor is said to work by blocking the growth of new blood vessels and by reducing the ability of fluid to pass through blood vessels in the eye by inhibiting VEGF-A and placental growth factor (PLGF), which are two growth factors involved in angiogenesis.