Regeneron Pharmaceuticals‘ (NSDQ:REGN) eye drug Eylea brought in nearly $6 billion in sales last year. In an attempt to keep the injectable drug in a league of its own, the biotech plans to apply for a new indication with the FDA this year.
The company today announced results from a Phase III trial evaluating Eylea in patients with non-proliferative diabeteic retinopathy. The study met its primary endpoint after 24 weeks – 58% of patients treated with Eylea had a two-step or greater improvement from baseline on the diabetic retinopathy severity scale compared to just 6% of patients receiving a sham injection.
“This is the first time a therapy has demonstrated it can reverse disease progression in patients with moderately severe to severe non-proliferative diabetic retinopathy without diabetic macular edema, in a trial specifically designed to study this population,” president & chief scientific officer Dr. George Yancopoulos said in prepared remarks. “Patients in the trial continue to be evaluated to determine if Eylea can prevent progression to neovascular vision-threatening complications or diabetic macular edema.”
The company plans to report one-year results from the 402-patient late-stage trial later this year. The results from Regeneron’s Panorama trial will support a supplemental biologics license application, the company reported.
Millions of people live with diabetic retinopathy, according to Regeneron, but the condition starts as non-proliferative diabetic retinopathy. More than half a million people in the U.S. have moderately severe or severe non-proliferative diabetic retinopathy without diabetic macular edema.