Regeneron Pharmaceuticals announced that the FDA has accepted for review the supplemental biologics license application of Eylea (aflibercept) injection for the treatment of diabetic retinopathy (DR). The target action date for the FDA decision is May 13, 2019.
The supplemental biologics license application submission is based on results from the phase 3 PANORAMA trial investigating Eylea as a treatment for patients with moderately severe to severe non-proliferative diabetic retinopathy without diabetic macular edema (DME). Positive 6-month topline results from PANORAMA were announced in March 2018. One-year results from PANORAMA are expected to be shared later this year.
The safety and efficacy of the potential use of Eylea in DR without DME has not been fully evaluated by any regulatory authority.
Eylea is administered as a 2 mg intravitreal injection and currently indicated to treat wet age-related macular degeneration, macular edema following retinal vein occlusion, DME, and DR in patients with DME.