FDA Approves Regeneron's Eylea (Aflibercept) for All Stages of Diabetic Retinopathy, Reducing Risk of Disease Progression by Up to 85%

Today, Regeneron Pharmaceuticals announced that the U.S. FDA has approved the company’s Eylea (aflibercept) for the treatment of all stages of diabetic retinopathy (DR), to reduce the risk of vision loss in patients.

Diabetic retinopathy (DR) is a common complication in patients with diabetes, caused by damage to the retinal blood vessels. It is estimated that there are 8 million DR patients worldwide. The early stage of this disease is non-proliferative diabetic retinopathy (NPDR), which usually has no obvious symptoms. However, over time, NPDR can progress to proliferative diabetic retinopathy (PDR). At this stage, abnormal blood vessel growth occurs on the surface of the retina and extends into the vitreous cavity, potentially leading to severe vision loss.

Eylea is a vascular endothelial growth factor (VEGF) inhibitor. It inhibits angiogenesis and reduces vascular permeability by blocking the signaling pathways mediated by VEGF-A and placental growth factor (PlGF). Previously, Eylea received FDA approval for the treatment of ophthalmic conditions such as wet age-related macular degeneration (AMD) and diabetic macular edema (DME).

▲Eylea (Image source: Reference [2])

This approval is based on the performance of Eylea in the Phase 3 clinical trial named PANORAMA. In this trial, 402 patients with moderate to severe NPDR received either intravitreal injections of Eylea or sham injections. These patients had not yet developed DME. The patients were divided into three groups, receiving Eylea injections every 8 weeks, every 16 weeks, or sham injections, respectively.

Trial results demonstrated that Eylea met the primary endpoint: after one year of treatment, the proportion of patients with improvement in retinopathy was significantly higher in the Eylea treatment groups than in the control group. Assessed using the Diabetic Retinopathy Severity Scale (DRSS), the proportions of patients achieving a two-step improvement in DRSS score were 65% in the group receiving injections every 16 weeks and 80% in the group receiving injections every 8 weeks. In the control group, this figure was 15%.

Meanwhile, Eylea reduced the risk of disease progression to proliferative diabetic retinopathy (PDR) or anterior segment neovascularization (ASNV) by 85% (with injections every 16 weeks) and 88% (with injections every 8 weeks), respectively.

▲Overview of PANORAMA Efficacy Data (Image source: Reference [1])

“Millions of patients have lost their vision due to the progression of diabetic retinopathy (DR),” said Dr. David Brown, one of the investigators of the PANORAMA trial. “The efficacy of Eylea in preventing the worsening of DR provides a compelling rationale for early treatment of this disease. Notably, receiving an injection only once every 16 weeks can significantly reduce the risk of disease progression.”

References:

[1] FDA Approves EYLEA® (aflibercept) Injection for Diabetic Retinopathy. Retrieved May 13, 2019, from https://www.prnewswire.com/news-releases/fda-approves-eylea-aflibercept-injection-for-diabetic-retinopathy-300849057.html

[2] Eylea. Retrieved May 13, 2019, from https://hcp.eylea.us/

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