Regeneron Pharmaceuticals, Inc. has received FDA approval for extended dosing intervals for EYLEA HD (aflibercept) injection 8 mg in two indications: wet age-related macular degeneration (AMD) and diabetic macular edema (DME).
Notably, this follows just 5 months after the intravitreal (IVT) injection was cleared for a new indication as well as other expanded dosing intervals (but more on that in a moment).
First, a look at EYLEA HD.
The vascular endothelial growth factor (VEGF) inhibitor was first approved by the FDA in 2023.
Among its cleared indications: wet AMD, DME, diabetic retinopathy (DR), and—as of November 2025—macular edema following retinal vein occlusion (RVO).
Speaking of dosings … talk more about the schedule for wet AMD and DME.
Prior to this updated approval, the dosing schedule for both indications was:
- Every 8 to 16 weeks following three initial monthly dosesEvery 4 weeks for “some patients who may benefit from resuming this dosing schedule”
Got it. So what’s this new dosing interval?
The extended dosing intervals include up to every 20 weeks for patients with wet AMD and DME following 1 year of successful response based on visual and anatomic outcomes.
And how is the extension noted on the EYLEA HD label?
The FDA updated the label to include 96-week (2-year) data from the pivotal clinical trials that supported both indications’ changes. See here for the prescribing information (PI).
And which trials were these?
- PULSAR trial (NCT04423718) for wet AMD
- PHOTON trial (NCT04429503) for DME
Regeneron noted that both studies demonstrated “sustained efficacy and safety through 2 years with extended dosing intervals.”
Talk details on this data.
The company reported that, of the EYLEA HD patients who completed week 96 of each study (583 and 395 participants in the PULSAR and PHOTON, respectively), “the vast majority maintained or further extended their dosing intervals while visual and anatomic improvements remained consistent with those achieved in the first 48 weeks.”
The numbers (at week 96):
- PULSAR: 71% of patients reached dosing intervals of at least 16 weeks, and 47% reached at least 20 weeks.
- Click here and here for our coverage on this study
- PHOTON: 72% of patients reached dosing intervals of at least 16 weeks, and 44% reached at least 20 weeks
- Check out our prior coverage on this study
Also: See here for common adverse events (AEs).
And what’s the big-picture significance behind the expanded dosing intervals?
With EYLEA HD now able to be individualized for wet AMD and DME patients (from every 4 weeks to every 30 weeks), “this further extends the widest range of dosing intervals of any approved injectable anti-VEGF,” Regeneron stated.
Impressive … is there any other EYLEA HD news to keep an eye on?
Looking ahead, Regeneron is still anticipating the FDA’s approval for a prefilled syringe (PFS) version of the drug. Its current target action date is later this month.
As always, stay tuned for developments!