FDA OKs Aflibercept (Eylea) for Diabetic Retinopathy

Megan Brooks

May 14, 2019

The US Food and Drug Administration (FDA) has approved aflibercept (Eylea, Regeneron) injection solution to treat all stages of diabetic retinopathy, the manufacturer has announced.

Aflibercept, a vascular endothelial growth factor (VEGF) inhibitor, is already approved in the United States for neovascular (wet) age-related macular degeneration, macular edema after central retinal vein occlusion, and diabetic macular edema.

"Millions of people have been robbed of their vision due to the progression of diabetic retinopathy," David Brown, MD, director of research at Retina Consultants of Houston, Texas, said in a company news release.

"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 Brown.

The FDA approved aflibercept for diabetic retinopathy based on 6-month and 1-year results from the phase 3 PANORAMA trial, which investigated aflibercept for improvement of moderately severe to severe nonproliferative diabetic retinopathy without diabetic macular edema compared with sham injection. A total of 402 patients participated.

"The PANORAMA trial showed that by 1 year 20% of untreated patients developed proliferative diabetic eye disease, and Eylea reduced this risk by 85% to 88% when administered using an every 16-week or 8-week dosing regimen, respectively. In fact, 80% of patients who received the Eylea 8-week dosing regimen had significant improvement in their diabetic retinopathy," George Yancopoulos, MD, PhD, president and chief scientific officer at Regeneron, said in the release.

Safety data from 269 patients with nonproliferative diabetic retinopathy through the first year were in line with the phase 3 VIVID and VISTA trials.

The recommended dose for aflibercept in patients with diabetic retinopathy is 2 mg (0.05 mL) administered by intravitreal injection every 4 weeks (approximately every 28 days, monthly) for the first five injections followed by 2 mg (0.05 mL) by intravitreal injection once every 8 weeks (2 months).

Serious adverse reactions related to the injection procedure have occurred in < 0.1% of intravitreal injections with aflibercept including endophthalmitis and retinal detachment. The most common adverse reactions (≥ 5%) reported in patients receiving aflibercept were conjunctival hemorrhage, eye pain, cataract, vitreous detachment, vitreous floaters, and increased intraocular pressure.

Full prescribing information is available online.

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