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