USFDA gives nod for Aflibercept injection to treat infants with prematurity issue

For the first time, physicians will now have an USFDA approved medication in EYLEA to treat this heartbreaking disease in these smallest of patients."

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Last Updated on December 31, 2023 by The Health Master

Tarrytown: Regeneron Pharmaceuticals, Inc. has announced that the U.S. Food and Drug Administration (USFDA) has approved EYLEA (aflibercept) injection to treat preterm infants with retinopathy of prematurity (ROP).

Following this first pediatric approval, EYLEA is now indicated to treat five retinal conditions caused by ocular angiogenesis.

“Retinopathy of prematurity is a leading cause of childhood blindness worldwide.”

“Until now, the only USFDA-approved treatment in common use was laser photocoagulation, a complex and lengthy procedure that permanently ablates retina tissue and is stressful not only for infant patients but also the family navigating a delicate time after a preterm birth,” said George D. Yancopoulos, M.D., Ph.D., President and Chief Scientific Officer of Regeneron, and a principal inventor of EYLEA.

“For the first time, physicians will now have an USFDA approved medication in EYLEA to treat this heartbreaking disease in these smallest of patients.” “We thank the investigators and the many families who participated in the clinical trials.”

EYLEA is being jointly developed by Regeneron and Bayer.

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