FDA Expands Eylea Approval to Include Diabetic Retinopathy

March 31, 2015

Regeneron has won yet another indication for its Eylea injection, this time for patients with diabetic macular edema who develop retinopathy.

The company evaluated Eylea (aflibercept) against macular laser photocoagulation in two Phase III clinical trials. Patients who received Eylea monthly or every two months were able to read two more lines on an eye chart at week 100 than were patients in the control arm, Regeneron says.

That dosing schedule is one of the product’s benefits, the company claims. While other treatments for this indication require monthly dosing, Eylea allows patients to drop back to once every two months after the fifth month of treatment, Regeneron says.

The FDA granted Eylea breakthrough therapy designation and priority review last year. The injection was previously approved for wet age-related macular degeneration and macular edema following retinal vein occlusions.

Eylea generated roughly $1.7 billion in U.S. sales in 2014, a 23 percent gain over the previous year, according to Regeneron. — Lena Freund