Regeneron Pharmaceuticals, Inc., announced it has received regulatory approval for a new indication and dosing option for EYLEA HD (aflibercept) injection 8 mg.
This news follows mere weeks after the FDA issued a company response letter (CRL) to Regeneron.
Talk about a turn of events. Let’s begin with EYLEA HD.
This high-dose aflibercept therapeutic (a contrast to EYLEA’s low-dose [2 mg] aflibercept dosage) is administered as an intravitreal (IVT) for the following retinal diseases:
- Wet age-related macular degeneration (AMD)
- Dosing schedule: Every 8 to 16 weeks following three initial monthly doses
- Diabetic macular edema (DME)
- Dosing schedule: Every 8 to 16 weeks following three initial monthly doses
- Diabetic retinopathy (DR)
- Dosing schedule: Every 8 to 12 weeks following three initial monthly doses
See here for a more detailed rundown on the therapeutic (as we’ve previously [and extensively] covered).
Now to this new approval.
The new indication: Macular edema following retinal vein occlusion (RVO)
- Its dosing schedule: Up to every 8-week dosing after an initial (three to five) monthly dosing
Check out the supporting clinical data this approval is based on.
And this expanded dosing option?
That would be an every-4-week (monthly, in other words) dosing option for “some patients who may benefit from resuming this dosing schedule” across EYLEA HD’s indications.
And before you ask: Yes, this also includes the therapeutic’s new macular edema following RVO indication.
What’s the intent behind these new approvals?
Starting with the new indication, EYLEA HD is now the first RVO treatment that could “potentially cut the number of injections that patients receive in half compared to existing therapies,” according to Regeneron’s George D. Yancopoulos, MD, PhD, co-founder, Board co-chair, president and chief scientific officer.
As for the expanded dosing option: The intent is to offer eyecare providers greater flexibility and optionality in tailoring treatments to patients’ individual needs.
Now hold up … what happened with that CRL issued last month?
Ah, yes—the reason behind the FDA’s delay of this approval in the first place (after an extended review period) …
As we previously reported, the federal agency took issue with the manufacturing facility Catalent Indiana, LLC (part of Novo Nordisk A/S)—the manufacturing filler for EYLEA HD’s pre-filled syringe (PFS) version.
- Specifically: “Unresolved issues”relating to a July 2025 general site inspection conducted by the FDA.
And have those issues since been resolved?
Not quite. Regeneron shared that it “continues to coordinate” with its manufacturing filler to resolve the outstanding issues from that FDA inspection.
Notably, the company emphasized that the inspection was “not specific to EYLEA HD”—which explains why this approval was given the green light.
What’s the plan then?
Regeneron intends to submit to the FDA an application to include an alternate PFS manufacturing filler for the EYLEA HD BLA by January 2026.
So you know what that means—stay tuned!