FDA Seems Set To Label Eylea For Retinopathy Of Prematurity Despite Failed Primary Endpoint
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.
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US FDA advisory committee recommends ‘more granularity’ in label on administration of Eylea in premature infants. Specifying intervals between injections is important for insurance coverage, agency official notes.
Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.
The US firm’s high-dose reformulation of Eylea reduced dosing burden for patients with DME and wet AMD in two pivotal studies and could match Roche’s rival drug.