Regeneron Pharmaceuticals (NSDQ:REGN) touted one-year results from a Phase III trial of its Eylea aflibercept injection in people with moderately severe to severe non-proliferative diabetic retinopathy.
The primary endpoint of the two-year Panorama trial is the proportion of patients who experience a two-step or greater improvement in the ‘diabetic retinopathy severity scale.’
Of the 133 people in the control group, 15% had an improved DRSS score compared to 65% of the 135 people treated with Eylea every 16 weeks and 80% of the 134 people treated with Eylea every 8 weeks.
Regeneron’s blockbuster Eylea product is delivered via intravitreal injection and is already approved to treat wet age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema and DR in patients with DME.
In September, Regeneron announced that the FDA plans to make a decision about the supplemental biologics license application for Eylea in diabetic retinopathy by May 13.
“Panorama provides high-quality data to inform treatment of NPDR without DME, as it is the first prospective trial involving these high-risk patients since the landmark ETDRS trial of the 1980s when laser was the only treatment option,” investigator Dr. Charles Wykoff said in prepared remarks.
“Without treatment, a large percentage of patients in the trial developed proliferative disease and CI-DME in the first year. Eylea treatment reduced the risk of these events by approximately 74% compared to sham injection, underscoring the potential importance of early Eylea anti-VEGF therapy. This efficacy was seen even with an every 16-week treatment regimen after loading doses, a management approach that may realistically be achieved in the real world,” Wykoff added.