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Regeneron's EYLEA SBLA For 16-week Dosing Regimen In Diabetic Retinopathy Accepted For FDA Review

Regeneron Pharmaceuticals Inc. (REGN) said Wednesday that the U.S. Food and Drug Administration has accepted for review the EYLEA (aflibercept) Injection supplemental Biologics License Application or sBLA for an every 16-week 2 mg dosing regimen (after initial monthly doses) in patients with diabetic retinopathy or DR. The target action date for the FDA decision is February 28, 2023.

If approved, extended regimen would provide a longer treatment interval and additional dosing flexibility, alongside approved every 4- and 8-week dosing regimens, the company said.

EYLEA was approved in 2019 for the treatment of all stages of DR with a dosing regimen of every 4 or 8 weeks after five initial monthly doses.

Diabetic retinopathy is an eye disease characterized by microvascular damage to the blood vessels in the retina often caused by poor blood sugar control in people with diabetes. The disease generally starts as NPDR and often has no warning signs or symptoms.

Non-proliferative diabetic retinopathy may progress to PDR, a stage of the disease in which abnormal blood vessels grow onto the surface of the retina and into the vitreous cavity, potentially causing severe vision loss. Diabetic macular edema or DME can occur at any stage of DR as the blood vessels in the retina become increasingly fragile and leak fluid, potentially causing visual impairment.

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