Sandoz releases positive results from Mylight Phase lll study for biosimilar Aflibercept

Mylight (ClinicalTrials.gov NCT04864834) is part of a comprehensive biosimilar development program that encompasses analytical, preclinical, and a clinical study. The Mylight Phase III confirmatory efficacy and safety study met its primary efficacy endpoint, showing therapeutic equivalence in mean change of best corrected visual acuity (BCVA) from baseline to week 8 between the biosimilar aflibercept and the reference biologic, Eylea. Safety, immunogenicity, and pharmacokinetics results further confirm that there is no clinically meaningful difference between the products.

The reference product Eylea is indicated to improve and subsequently maintain visual acuity in patients with Neovascular Age-Related Macular Degeneration (nAMD), Diabetic Macular Edema, macular edema secondary to Retinal Vein Occlusion (RVO), and other specific neovascular retinal diseases. These conditions cause blurring of central vision and, if untreated, can lead to permanent vision loss. nAMD affects over 200 million people worldwide and is one of the most widespread causes of blindness.

Claire D’Abreu-Hayling, Chief Scientific Officer, Sandoz, said, “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. 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.”

Sandoz provides critical and potentially life-changing biologic medicines across a wide range of therapeutic areas including ophthalmology, immunology, oncology, supportive care, and endocrinology. It has a global portfolio with eight marketed biosimilars and a further 24 assets in various stages of development.

Sandoz expects to file for regulatory approval for biosimilar aflibercept in the US and EU in the coming months.

Aflibercept is a recombinant fusion protein that binds to vascular endothelial growth factor A (VEGF-A) and placental growth factor (PlGF), inhibiting abnormal vessel growth. In patients with neovascular retinal diseases, like neovascular age-related macular degeneration (nAMD), diabetic macular edema (DME), or retinal vein occlusion (RVO), aflibercept is injected into the eye to improve visual acuity and inhibit disease progression.