FDA Rejects Extended Dosing Intervals for Eylea HD - Summary - 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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Objective:

To report on the FDA's decision regarding Regeneron's supplemental biologics license application for Eylea HD.

Approach:
  • FDA Response: The FDA issued a complete response letter (CRL) rejecting the proposal for extended dosing intervals beyond 16 weeks for Eylea HD.
  • Current Dosing Regimens: Eylea HD is currently approved for dosing intervals of every 8 to 16 weeks for wet AMD and DME, and every 8 to 12 weeks for DR.
Key Findings:
  • The FDA did not identify any safety or efficacy issues with Eylea HD.
  • Regeneron is evaluating the FDA's decision and will determine a path forward.
Interpretation:

Limitations:
  • The CRL limits dosing flexibility for patients requiring treatment.
Conclusion:

Regeneron received priority review status for a separate application related to macular edema secondary to retinal vein occlusion.

Sources:

Original Source(s)

FDA Rejects Extended Dosing Intervals for Eylea HD

  • by Retinal Physician

  • April 24, 2025

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