From the Journals
FDA & Government News

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.

Share

Regeneron Pharmaceuticals received a complete response letter from the FDA for the addition of extended dosing intervals for aflibercept 8 mg (Eylea HD) across all approved indications. The FDA did not agree with Regeneron's proposal to add dosing intervals greater than every 16 weeks. Despite this, the CRL did not identify any safety or efficacy issues with Eylea HD in its approved indications and dosing regimens.

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

Related Content

Metformin and AMD: Signal or Noise?

Five-year population study details 37% lower incidence of intermediate AMD in type 2 diabetic patients prescribed metformin

Integration of Vision Services Remains an Unmet Need in FQHCs

Telemedicine, funding, and provider partnerships can help, researchers say.

Port Delivery System With Ranibizumab for Diabetic Eye Disease

Researchers determined that the PDS may decrease the treatment burden of frequent intravitreal injections, but further research on efficacy and safety is needed.