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Ophthalmology AdvisorFDA Approves Extended Eylea HD Dosing Interval for wAMD, DME

The FDA has approved an extended dosing interval for Eylea HD® (aflibercept 8 mg) in patients with wet age‑related macular degeneration (wAMD) and diabetic macular edema (DME). Patients who maintain stable visual and anatomic outcomes after one year of treatment may now transition to dosing every 20 weeks, expanding upon the previous maximum interval of 16 weeks.


Clinical Considerations

  • The approval is based on 96‑week data from the phase 3 PULSAR trial (wAMD; N=1009) and phase 2/3 PHOTON trial (DME; N=658).
  • Eylea HD administered every 12 or 16 weeks demonstrated noninferior BCVA gains compared with Eylea 2 mg every 8 weeks at week 48.
  • Long‑term data showed maintenance of visual acuity through week 96 across both studies.
  • By week 96, ~47% of wAMD patients and ~44% of DME patients achieved dosing intervals of 20 weeks or longer.
  • Adverse events were consistent with known intravitreal anti‑VEGF safety profiles, including cataract and transient IOP elevation.

Practice Applications

  • For retina specialists: This approval supports individualized extension strategies for patients who show durable anatomic and visual stability after one year on Eylea HD.
  • For comprehensive ophthalmologists: Longer dosing intervals may reduce treatment burden and improve adherence in suitable patients.
  • For optometrists: Expect fewer injection visits for stable patients; reinforce ongoing monitoring and symptom reporting between extended intervals.
  • For opticians: Changes in visit frequency may alter postoperative and retinal follow‑up timing, but do not change refractive correction needs.

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