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FDA Seems Set To Label Eylea For Retinopathy Of Prematurity Despite Failed Primary Endpoint

 
• By Brenda Sandburg

Two studies failed to demonstrate that Eylea was non-inferior to laser treatment. Agency says compared to the expected natural history, there is a ‘clear beneficial effect’ of Eylea which also maintains peripheral vision. Advisory committee to discuss how to convey findings in label.

Premature infant
FDA panel to consider labeling of Eylea for treatment of retinopathy of prematurity in preterm infants. • Source: Shutterstock

The US Food and Drug Administration asked Regeneron Pharmaceuticals, Inc. to conduct studies to evaluate the potential use of Eylea (aflibercept) in the treatment of retinopathy of prematurity, a leading cause of childhood blindness. While the two studies conducted did not meet the primary endpoint of non-inferiority to laser treatment, the agency noted that the drug could still be labeled for the indication with information about the results of the studies.

At its 9 January meeting, the FDA’s Dermatologic and Ophthalmic Drugs Advisory Committee will discuss the wording of the label...

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