Published in Pipeline

FDA grants aflibercept priority review for retinal diseases

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3 min read

Regeneron Pharmaceuticals, Inc., in joint development with Bayer AG, announced that the FDA has accepted its Biologics License Application (BLA) for aflibercept to treat patients diagnosed with wet age-related macular degeneration (AMD), diabetic macular edema (DME), and diabetic retinopathy (DR).

Tell me about aflibercept.

Aflibercept is in a medication class of vascular endothelial growth factor A (VEGF-A) and placental growth factor (PIGF) antagonists that stops the growth of abnormal blood vessels and leakage in the eyes in patients diagnosed with retinal diseases.

How does 8 mg aflibercept compare to Eylea?

While both medications are intravitreal injections of aflibercept formulations, Eylea is a 2 mg dosage prescription medicine. Additionally, Eylea is FDA approved for the treatment of wet AMD; macular edema following retinal vein occlusion (RVO); DME; DR; and—most recently—for the treatment of retinopathy of prematurity (ROP) in infants.

What did clinical trials show?

The double-masked, active-controlled PULSAR (NCT04423718) study for wet AMD (n = 673) and PHOTON (NCT04429503) study for DME (n = 491) randomized patients to receive either aflibercept 8 mg for 12 weeks, aflibercept 8 mg for 16 weeks, and Eylea for 8 weeks.

Both trials reported positive data and met their primary endpoint of non-inferiority in vision gains for patients treated with 8 mg aflibercept during 12- and 16-week dosing regimens following initial monthly dosing regimens at 48 weeks for patients treated compared to 8 weeks of dosing in patients treated with an Eylea (aflibercept) injection (PULSAR, n = 336; PHOTON, n= 167)

Anything else?

In both trials, more than 75% of patients treated with 8 mg aflibercept were able to maintain the 12- and 16-week dosing regimens through the 48-week period (PULSAR : 79% and 77%; PHOTON: 91% and 89%).

Any adverse effects?

In comparison to Eylea, ocular adverse effects from 8 m aflibercept were observed in 31% vs 28% in PHOTON and 38% vs 39% in PULSAR, respectively.

What’s next?

With the use of a priority review voucher (PRV)—which accelerates the FDA review process for a potentially more profitable drug that treats certain diseases and illnesses—the FDA has set a target action date of June 27, 2023.


If approved, 8 mg aflibercept has the potential to become Regeneron’s second ophthalmic medication in the retina space.