Regeneron says FDA rejects pre-filled syringe version of Eylea, but reports eye drug met main goals in Phase III non-proliferative diabetic retinopathy study

Regeneron Pharmaceuticals announced Thursday that the FDA issued a complete response letter regarding the pre-filled syringe version of its eye drug Eylea (aflibercept), adding that the agency has requested more information about manufacturing and supply processes. The FDA has also asked for the completion of a usability study evaluating a single injection of the Eylea pre-filled syringe in approximately 30 patients. The drugmaker indicated that it plans to resubmit its application early in 2019, and continues to expect the Eylea pre-filled syringe will be launched next year. 

Also on Thursday, Regeneron unveiled clinical results illustrating that its currently available Eylea injection met both the primary endpoint and key secondary endpoints of the late-stage PANORAMA study of patients with moderately severe and severe non-proliferative diabetic retinopathy (NPDR). On the primary endpoint, results showed that 80 percent and 65 percent of patients who received the drug every eight weeks and every 16 weeks, respectively, experienced at least a two-step improvement from baseline on the Diabetic Retinopathy Severity Scale (DRSS) at one year, compared to 15 percent for placebo. Chief scientific officer George Yancopoulos remarked "these results point to the potential value of earlier intervention in diabetic retinopathy and may in the future change the way retina specialists treat this disease." 

The PANORAMA study evaluated Eylea injection for the improvement of moderately severe to severe NPDR in 402 patients without diabetic macular oedema (DME). Participants were randomly assigned to treatment with Eylea at eight- or 16-week intervals after an initial monthly dosing period, or placebo. In addition to the primary endpoint of a two-step or greater improvement on the DRSS from baseline for the combined Eylea treatment groups at week 24, and for each Eylea treatment group separately at week 52, key secondary endpoints included reductions in the frequency of vision-threatening complications (VTCs) or the development of centre-involved DME. 

Study results showed that the proportions of patients who experienced VTCs in the eight-week and 16-week Eylea groups were 3 percent and 4 percent, respectively, compared to 20 percent for placebo. In addition, centre-involved DME was identified in 8 percent and 7 percent of patients in the eight-week and 16-week dose groups, respectively, versus 26 percent for placebo.

Regeneron noted that one-year results from the study will be presented at an upcoming research conference. The drugmaker's filing seeking approval of Eylea for the treatment of NPDR based on previously reported 24-week data from the PANORAMA study was accepted for review by the FDA last month, with a target action date of May 13, 2019. 

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