FDA Accepts Aflibercept sBLA for Treatment of Diabetic Retinopathy

The FDA accepted aflibercept’s (Eylea; Regeneron Pharmaceuticals) supplemental biologics license application (sBLA) for an every 16-week 2 mg dosing regimen after initial monthly doses for individuals with diabetic retinopathy (DR).¹

The target action date from the FDA decision is February 28, 2023.1

In 2019, aflibercept was approved for the treatment of all stages of DR with a dosing regimen of every 4 or 8 weeks after 5 initial monthly doses. If approved, the 16-week dosing regimen could offer certain individuals a potentially longer treatment interval and physicians with greater flexibility to individualize treatment.¹

The sBLA is supported by data from the phase 3 PANORAMA trial investigating every 8- and 16-week aflibercept dosing regimens compared to sham in individuals with severe non-proliferative diabetic retinopathy (NPDR) without diabetic macular edema (DME). The submission was further supported by data from the NIH-sponsored Protocol W trial, which investigated an aflibercept every 16-week regimen in individuals with moderate to severe NPDR without center-involved DME compared to sham.¹

At 1 year, PANORAMA met its primary endpoint of proportion of individuals ≥2-step improvement in Diabetic Retinopathy Severity Scale (DRSS) score.¹

Investigators said that, at 2 years, in both trials a greater number of individuals receiving aflibercept every 16-weeks experienced a ≥2-step improvement in DRSS score, along with greater reductions in the risk of developing vision-threatening complications when compared to sham.¹

The rates of serious ocular adverse events (AEs) and intraocular inflammation in individuals treated with aflibercept were similar during both studies. The most common AEs reported were increased redness in the eye, eye pain, cataract, vitreous detachment, vitreous floaters, moving sports in the field of vision, and increased pressure in the eye.¹

Additionally to DR with a 4- or 8-week dosing regimen, aflibercept is approved for the treatment of neovascular, known as wet, age-related macular degeneration, macular edema following retinal vein occlusion and DME.¹

The use for the 16-week dosing regimen for aflibercept in DR has not been fully evaluated by any regulatory authority.¹

Aflibercept is a VEGF inhibitor formulated as an injection for the eye that blocks the growth of new blood vesicles and decreases the ability of fluid to pass through blood vessels in the eye.¹

According to the CDC, DR is a common eye disease that leads to blindness in working-age adults. DR is caused when high blood sugar damages blood vessels in the retina which can cause swelling and leaking, leading to blurry vision or stopping blood flow.²

Risk factors for DR include high blood sugar, pressure, or cholesterol, smoking, and race and ethnicity. Anyone with type 1 diabetes, type 2 diabetes, or gestational diabetes can develop DR, with the risk increasing the longer an individual has diabetes.²

DR is the leading cause of blindness in working age-adults.²

Reference

1. Eylea (aflibercept) injection sBLA for every 16-week dosing regimen in patients with diabetic retinopathy accepted for FDA review. Regeneron. News release. June 29, 2022. Accessed June 30, 2022. https://investor.regeneron.com/news-releases/news-release-details/eylear-aflibercept-injection-sbla-every-16-week-dosing-regimen

2. Centers for Disease Control and Prevention. Diabetes. Diabetes and Vision Loss. Updated May 7, 2021. Accessed June 30, 2022. https://www.cdc.gov/diabetes/managing/diabetes-vision-loss.html