Regeneron Pharmaceuticals (NSDQ:REGN) announced data supporting the use of its EYLEA injection in NPDR patients.
Protocol W, a NIH-sponsored trial to evaluate the EYLEA (aflibercept) injection in patients with moderate to severe non-proliferative diabetic retinopathy (NPDR), without center-involved diabetic macular edema (CI-DME), had its initial results published in JAMA Ophthalmology.
At two years, the primary outcome of the trial showed a 68% reduced risk of developing vision-threatening complications (either proliferative diabetic retinopathy [PDR] or CI-DME with vision loss) for those who received the EYLEA injection in an every-16-weeks dosing regimen, according to a news release. Those tho received sham injections were almost five times more likely to experience disease progression requiring EYLEA rescue therapy.
Preventive EYLEA treatment did not present a significant difference in visual acuity when compared to delayed treatment, although a Regeneron follow-up analysis in the Panorama trial found that delayed EYLEA treatment resulted in three times as many patients suffering prolonged vision loss compared to those who received the treatment during a two-year period. The company has not yet conducted a similar follow-up analysis for the Protocol W trial.
No new safety signals were identified in Protocol W, falling in line with the known safety profile of the EYLEA injection. Ocular adverse events included endophthalmitis, while the rate of cardiovascular-cerebrovascular adverse events was not significantly different among the treatment groups.
Regeneron touts EYLEA as the only vascular endothelial growth factor (VEGF) inhibitor that has FDA approval with two dosing intervals for DR, offering the option to customize treatment. It is not yet approved for the 16-week dosing regimen observed in Protocol W
“Blindness is one of the most feared consequences of diabetic retinopathy, and we thank the National Eye Institute and the DRCR Retina Network for conducting a well-controlled trial that provides useful information to guide treatment in these patients,” Regeneron president & CSO Dr. George D. Yancopoulos said in the news release. “Protocol W confirms the landmark results of the similarly-designed Panorama trial, underscoring the importance of early and regular diabetic retinopathy treatment and the ability of EYLEA to substantially reduce vision-threatening complications and improve disease severity. Importantly, these results were obtained with an every-16-weeks EYLEA dosing regimen, confirming the efficacy with EYLEA seen in the Panorama trial.”