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Regeneron Publishes 96 Week Results of Aflibercept 8mg In wAMD

Aug 10, 2023

On 10 August 2023, Regeneron announced the results of two-year (96 week) data from its PULSAR trials investigating aflibercept 8mg in wet age-related macular degeneration.  Regeneron reported that aflibercept 8mg demonstrated durable vision gains at extended dosing intervals (including intervals greater than 12 weeks) and that the safety of aflibercept 8mg remained consistent with the known safety profile of Eylea®.

The BLA for aflibercept 8mg for was accepted by the FDA for priority review in February 2023, and has not yet been approved by any regulatory authority.  In June 2023 Regeneron announced that the FDA had issued a Complete Response Letter (CRL) in relation to the Regeneron BLA for aflibercept 8 mg.