FDA Rejects Extended Dosing Intervals for Eylea HD - Takeaways - MDSpire

FDA Rejects Extended Dosing Intervals for Eylea HD

The agency did not agree with Regeneron’s proposal to add dosing intervals greater than every 16 weeks, the maximum interval currently indicated for aflibercept 8 mg injections.

  • By

  • Retinal Physician

  • April 24, 2025

  • 2 min

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  • 1

    The FDA issued a complete response letter to Regeneron's sBLA for extended dosing intervals of Eylea HD.

  • 2

    The FDA did not approve dosing intervals greater than every 16 weeks for Eylea HD, which is currently the maximum indicated.

  • 3

    The CRL did not raise any concerns regarding the safety or efficacy of Eylea HD in its approved uses.

  • 4

    Eylea HD is approved for dosing intervals of 8 to 16 weeks for wet AMD and DME, and 8 to 12 weeks for DR.

  • 5

    Regeneron is evaluating the FDA's decision and will determine its next steps.

Original Source(s)

FDA Rejects Extended Dosing Intervals for Eylea HD

  • by Retinal Physician

  • April 24, 2025

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