Regeneron Pharmaceuticals, Inc. has received FDA acceptance for priority review of its supplemental Biologics License Application (sBLA) for EYLEA HD (aflibercept) injection 8 mg.
First things first: How does a sBLA differ from a BLA?
To start: A Biologics License Application (BLA) is an official request to the FDA for permission to introduce or deliver a biologic product through interstate commerce.
- Essentially: This regulatory process is designed to ensure a product is safe, pure, and potent—with supporting pre-clinical and clinical research to back it up.
Comparatively: A supplemental BLA (sBLA) is considered a follow-up to an original BLA for a new treatment indication and more extended clinical data to support the claim.
- Important to note, however: If the sBLA is for the same indication, the new data could indicate a change in treatment protocol.
Got it. Now a rundown on EYLEA HD.
The therapeutic: A vascular endothelial growth factor (VEGF) inhibitor administered via intravitreal (IVT) injection.
Its regulatory status: Jointly developed by Regeneron and Bayer AG (which owns exclusive marketing rights outside the U.S.), EYLEA HD was granted FDA approval in August 2023 for three retinal indications:
- Wet age-related macular degeneration (AMD)
- Diabetic macular edema (DME)
- Diabetic retinopathy (DR)
Notably: This 8 mg injection of aflibercept differs from Regeneron’s FDA-approved 2 mg injection of aflibercept (EYLEA; indicated for wet AMD, DME, DR, and retinopathy of prematurity [ROP]).
So what is this sBLA seeking for the drug?
Regeneron is seeking approval for one new indication and an update to EYLEA HD’s dosing schedule for its already-established indications.
- The new indication: Macula edema following retinal vein occlusion (RVO)
- The proposed updated dosing schedule, according to the company:
- Every 8-week dosing for the treatment of macular edema following RVO
- Every 4-week (monthly) dosing across currently approved indications (wet AMD, DME and DR)
Quick refresher: What is its current dosing schedule?
Per EYLEA HD’s prescribing information (PI), the recommended dose is 8 mg (0.07 mL of 114.3 mg/mL solution) administered via IVT injection every 4 weeks (monthly) for the first 3 months, followed by:
- For wet AMD and DME:
- 8 mg every 8 to 16 weeks (2 to 4 months)
- For DR:
- 8 mg every 8 to 12 weeks (2 to 3 months)
And what clinical data is this new approval based on?
While the company referenced clinical findings from across the therapeutic’s clinical program, it called out recent data released (in February 2025) from the phase 3 QUASAR trial.
A few study details: This 64-week, global, double-masked, active-controlled trial enrolled 892 patients diagnosed with macular edema following RVO.
- See here for details on the three dosing groups receiving either EYLEA HD or EYLEA alone.
- The primary endpoint: A mean change in best-corrected visual acuity (BCVA) from randomization through Week 36, measured via Early Treatment Diabetic Retinopathy Study (ETDRS) letter score
And the findings?
The study met its primary endpoint at 36 weeks, with two EYLEA HD groups (dosed every 8 weeks) achieving non-inferior VA gains compared to the EYLEA group (dosed every 2 weeks).
Give me some numbers.
In both EYLEA HD groups:
- 88% sustained an 8-week dosing regimen following the required 3 monthly doses
- 93% maintained the 8-week dosing regimen after completing 5 initial monthly doses.
As for EYLEA HD’s safety profile: This was observed to be “generally consistent” with its performance in previous trials for those original approved indications.
- Check out the related adverse events (occurring in ≥5% of all EYLEA HD patients).
And what was significant about this?
In presenting this data during the virtual Angiogenesis, Exudation, and Degeneration 2025 annual meeting, Seenu M. Hariprasad, MD, chair of the Department of Ophthalmology and Visual Science at the University of Chicago, noted the promising EYLEA HD holds for its proposed new indication.
- “Based on these new data, [EYLEA HD] may offer the potential to halve the number of injections needed, as compared to standard-of-care [EYLEA] and other anti-VEGF therapies,” she stated.
Even further: Regeneron more recently noted that this potential for frequent monthly dosing for all the therapeutic's approved retinal indications could “provide greater dosing flexibility for physicians and patients.”
And the big-picture outlook?
If the FDA grants approval, EYLEA HD would be the “first and only treatment for RVO indicated for up to every 8-week dosing after an initial monthly dosing period,” the company emphasized.
To note: Currently, all anti-VEGF therapies approved to treat RVO, including EYLEA (2 mg), are indicated for monthly dosing.
Very exciting! So what’s next?
The FDA has set a target action date of Aug. 19, 2025, following the use of a priority review voucher (PRV), the company noted.
Keep in mind: A PRV accelerates the FDA review process for a potentially more profitable drug that treats certain diseases (such as macula edema following RVO, in this case) and illnesses.