Regeneron’s Eylea wins FDA approval

The approval was based on the The PANORAMA trial, which showed that by one 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 eight-week dosing regimen, respectively. 80% of patients who received the Eylea eight-week dosing regimen had significant improvement in their diabetic retinopathy.

The injection is a vascular endothelial growth factor (VEGF) inhibitor formulated as an injection for the eye. It is designed to block the growth of new blood vessels and decrease the ability of fluid to pass through blood vessels in the eye by blocking VEGF-A and placental growth factor

The drug is the only VEGF inhibitor approved with two dosing options for DR, allowing doctors to customise treatment to their patients' needs.

"Millions of people have been robbed of their vision due to the progression of diabetic retinopathy," said David Brown, an investigator for the PANORAMA trial and director of research at Retina Consultants of Houston.

"The prevention of worsening diabetic retinopathy with Eylea provides a compelling rationale for early treatment of patients with this disease," he continued, "particularly since eyes dosed with Eylea as infrequently as every 16 weeks showed significant improvements in the pivotal PANORAMA trial."

Approximately eight million people live with DR, a complication of diabetes characterised by damage to the blood vessels in the retina. The disease generally starts as non-proliferative diabetic retinopathy (NPDR) and often has no warning signs or symptoms.

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