Regeneron Pharmaceuticals has reported initial results from the Protocol W study of Eylea (aflibercept) injection, which found a 68% reduced risk of developing vision-threatening complications in patients with moderate to severe non-proliferative diabetic retinopathy (NPDR) of the center showed diabetic macular edema (CI-DME).
Eylea is a VEGF inhibitor and is formulated as an eye injection. It can potentially hinder the growth of new blood vessels and reduce the chance of fluid passing through blood vessels in the eye by inhibiting VEGF-A and placental growth factor (PLGF).
The National Institutes of Health-sponsored, four-year, randomized, multicenter, controlled study analyzed the effectiveness of Eylea versus sham in preventing vision-threatening complications in high-risk patients.
In the study, patients were randomized to receive either a sham or 2 mg Eylea every 16 weeks after receiving four starting doses at zero, four, eight and 16 weeks.
The primary outcome of the study after two years was time to development of CI-DME with vision loss, or PDR.
Initial data showed that after two years, subjects who received Eylea every 16 weeks were seen to have a 68% lower risk of developing vision-threatening complications (either PDR or CI-DME with vision loss).
In addition, patients given sham injections had almost five times more chance of experiencing disease progression that required EYLEA rescue therapy.
George Yancopoulos, President and Chief Scientific Officer of Regeneron, said, “Protocol W confirms the landmark results of the similarly designed PANORAMA study and underscores the importance of early and regular treatment for diabetic retinopathy and Eylea’s ability to significantly reduce vision-threatening complications and disease to improve severity.
“It is important that these results were achieved with an Eylea dosage regimen every 16 weeks, which confirms the effectiveness of Eylea in the PANORAMA study.”
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According to a recent follow-up analysis in a similar PANORAMA study, delaying Eylea treatment resulted in three times as many patients suffering prolonged vision loss as those who received preventive Eylea treatment for two years.
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August 28, 2020
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