Biosimilar Aflibercept Shows Positive Efficacy and Safety Results in Confirmatory Study

Sandoz recently released positive results from the Mylight phase 3 confirmatory efficacy and safety study for its biosimilar aflibercept for patients with wet macular degeneration, according to a statement released by the company.

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Mylight is a component of a comprehensive biosimilar development program that encompasses analytical, preclinical, and a clinical study. The phase 3 study met its primary endpoint by showing therapeutic equivalence in mean change of best corrected visual acuity (BCVA) from baseline to week 8 between aflibercept and its reference biologic, Eylea.

The clinical trial enrolled 485 patients across 16 countries. nAMD patients were randomized 1:1 to receive either biosimilar aflibercept or Eylea for 48 weeks, followed by a safety follow-up period of 4 weeks. The total duration of the trial was 52 weeks.

The safety, immunogenicity, and pharmacokinetics results further confirmed that there is no clinically meaningful difference between each product.

Eylea, the reference product, is indicated to improve and maintain visual acuity in patients with neovascular retinal diseases, such as neovascular age-related macular degeneration (nAMD), diabetic macular edema (DME), and macular edema secondary to retinal vein occlusion (RVO).

These conditions can cause blurring of central vision and can lead to permanent vision loss if left untreated. nAMD affects more than 200 million people worldwide and is one of the most common and widespread causes of blindness.

Aflibercept is a recombinant fusion protein that binds to vascular endothelial growth factor A (VEGF-A) and placental growth factor (PIGF), thereby inhibiting abnormal vessel growth. In patients with neovascular retinal diseases, such as nAMD, DME or RVO, aflibercept is injected into the eye to improve visual acuity and to prevent the progression of disease.

“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 at Sandoz, in the 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.”

Reference

Novartis. Sandoz announces positive results from Mylight phase III study for biosimilar aflibercept. News release. Accessed on August 16, 2023. Published August 15, 2023. Accessible at https://www.novartis.com/news/media-releases/sandoz-announces-positive-results-from-mylight-phase-lll-study-biosimilar-aflibercept.