FDA approves aflibercept for diabetic retinopathy

Aflibercept is now an approved treatment for all stages of diabetic retinopathy (DR), making it the only anti-VEGF agent with two dosing options for DR.

The drug was already indicated for the treatment of patients with wet AMD, macular edema following retinal vein occlusion and diabetic macular edema.

The new indication was approved after the phase 3 PANORAMA trial concluded that intravitreal injections of aflibercept, given every 8 or 16 weeks after an initial dosing period, significantly improved DR and lowered the risk of disease progression. Both dosing regimens reduced the risk of proliferative diabetic eye disease by 85% to 88% by 1 year. About 80% of patients on the 8-week regimen showed significant improvement in their retinopathy.

“The prevention of worsening diabetic retinopathy with Eylea provides a compelling rationale for early treatment of patients with this disease, particularly since eyes dosed with Eylea as infrequently as every 16 weeks showed significant improvements in the pivotal PANORAMA trial,” said trial investigator David Brown, MD, director of research at Retina Consultants of Houston, in a company press release.

Serious reactions such as endophthalmitis or retinal detachment developed in fewer than 0.1% of injected eyes. The most common reactions were conjunctival hemorrhage, eye pain, cataract, vitreous detachment, vitreous floaters and elevated IOP.