Recent results of the MYLIGHT (NCT04864834) Phase 3 study reported the aflibercept biosimilar met its primary efficacy endpoint and showed no clinically meaningful differences compared with the reference product (Eylea). The drug is used to treat patients living with wet macular degeneration.

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According to a statement released by Sandoz, “results offer hope of new affordable option for patients with neovascular age-related macular degeneration (nAMD), a leading cause of visual impairment and progressive vision loss for older adults.”¹

Last month, Regeneron Pharmaceuticals announced the US Food and Drug Administration (FDA) approval of the aflibercept 8 mg reference product for the treatment of wet age-related macular degeneration (AMD), diabetic macular edema (DME), and diabetic retinopathy, making it the first treatment approved for wet AMD and DME for immediate dosing at 8- week and up to 16-week intervals following 3 initial monthly doses.²

The Trial

MYLIGHT, a double-masked, parallel 2-arm study, enrolled 485 patients with nAMD worldwide, with a focus on wet and exudative nAMD. Patients were randomized 1:1 to receive either the biosimilar or reference product for 48 weeks, followed by a safety follow-up period of 4 weeks.

The primary endpoint was the mean change in the best corrected visual acuity (BCVA) score from baseline to week 8. The confirmatory efficacy and safety study demonstrated therapeutic equivalence in addition to immunogenicity, pharmacokinetics, and safety.

The Biosimilar

Aflibercept, a recombinant fusion protein, works by binding to vascular endothelial growth factor A (VEGF-A) and placental growth factor (PIGF), which prevents abnormal vessel growth. The drug is injected into the eye to both inhibit the progression of disease and improve visual acuity in patients with nAMD, retinal vein occlusion (RVO), and DME. These conditions, which cause central vision blurring, can lead to permanent vision loss if left untreated. Currently, nAMD affects over 200 million people globally and is a leading cause of blindness.

Aflibercept is 1 of 4 high-value biosimilars Sandoz is planning to launch in the upcoming years. They are expecting to file for regulatory approval for the biosimilar in the United States and Europe within the coming months.

“This important milestone, confirming therapeutic equivalence of the biosimilar aflibercept with the reference biologic, takes us one step closer to providing patients with a key treatment in an area of high unmet need within ophthalmology,” said Claire D’Abreu-Hayling, Chief Scientific Officer, Sandoz, in a statement. “It also underscores our ability to provide high-quality, affordable biologics to individuals to help the treatment of their disease and highlights the rich Sandoz pipeline of biologics.”

References

1. ^{Sandoz announces positive results from Mylight Phase LLL study for biosimilar aflibercept. Sandoz. (2023, August 15). https://www.sandoz.com/news/media-releases/sandoz-announces-positive-results-from-mylight-phase-lll-study-biosimilar-aflibercept}
2. ^{Campbell, P. (2023, August 23). Aflibercept 8 mg (eylea HD) approved by FDA for wet AMD, DME, and Diabetic retinopathy. HCP Live. https://www.hcplive.com/view/aflibercept-8mg-eylea-hd-approved-by-fda-for-wamd-dme-and-diabetic-retinopathy}