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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.

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  • 1

    Regeneron received a complete response letter from the FDA regarding extended dosing intervals for Eylea HD.

  • 2

    The FDA did not agree with Regeneron's proposal for dosing intervals greater than every 16 weeks.

  • 3

    The CRL did not identify any safety or efficacy issues with Eylea HD in its approved indications and dosing regimens.

  • 4

    Eylea HD is approved with dosing intervals for wet AMD, DME, and DR.

  • 5

    Regeneron received priority review status for its sBLA for aflibercept 8 mg for macular edema secondary to retinal vein occlusion.

Original Source(s)

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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