Phase III PANORAMA trial of Eylea shows positive results in diabetic retinopathy.- Regeneron Pharma

Regeneron Pharmaceuticals announced positive two-year results from the Phase III PANORAMA trial evaluating Eylea (aflibercept) Injection 2 mg (0.05 mL) in patients with moderately severe to severe non-proliferative diabetic retinopathy (NPDR). The two-year pre-specified exploratory data demonstrate that untreated moderately severe and severe NPDR can lead to vision-threatening events, which includes vision-threatening complications (VTCs; proliferative diabetic retinopathy or anterior segment neovascularization) and center-involved diabetic macular edema (CI-DME). Based on a Kaplan-Meier analysis, more than half (58%) of patients in the untreated sham arm developed a VTC or CI-DME within two years of entering the trial, while Eylea treatment was shown to reduce the likelihood of these vision-threatening events by at least 75%. The two-year results also showed a greater benefit for Eylea patients treated at regular intervals compared to patients who received Eylea treatment less frequently. Per the protocol, the group of trial patients who received Eylea every 8 weeks in the first year were switched to receive it when their doctor determined they needed it (called pro re nata, or PRN) in the second year (i.e., the 8-week/PRN group). The proportion of these patients with a >2-step improvement from baseline in Diabetic Retinopathy Severity Scale (DRSS) scores decreased in the second year (80% improvement at 52 weeks and 50% at 100 weeks). By comparison, in patients who continued to receive Eylea every 16 weeks (i.e., the 16-week group), the >2-step DRSS scores remained consistent (65% at 52 weeks vs. 62% at 100 weeks). In the second year, patients received an average of 1.8 injections in the 8-week/PRN group (out of a possible 6); a review of data from the independent reading center of investigator PRN decisions suggests that some of these patients may have been under-dosed based on the protocol rules of the trial. Patients in the 16-week group received 2.6 injections (out of a possible 3) in the second year. During the 2-year PANORAMA trial, adverse events were consistent with the known profile of Eylea. Serious ocular adverse events in the study eye occurred in 2% and 0% of the Eylea 8-week/PRN and 16-week groups, respectively, and 2% of patients in the sham group. Ocular inflammation occurred in 2% and 1% of patients in the Eylea treatment groups, respectively, and 1% of patients in the sham group. Anti-platelet trialists' collaboration (APTC)-defined arterial thromboembolic treatment emergent events occurred in 3% and 6% of patients in the Eylea treatment groups, respectively, and 5% of patients in the sham group. The data were presented for the first time at the Angiogenesis, Exudation, and Degeneration 2020 meeting.