Sandoz, a global leader in off-patent medicines, releases positive results from the MYLIGHT Phase III confirmatory efficacy and safety study for its biosimilar aflibercept, for patients living with wet macular degeneration – a key development in its efforts to address this area of unmet medical need.
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 is committed to helping millions of patients by providing affordable access to 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 leading global portfolio with eight marketed biosimilars and a further 24 assets in various stages of development. Since launching the first biosimilar in Europe in 2006, Sandoz has demonstrated that biosimilars can significantly expand patient access to highly effective and safe medicines while increasing healthcare savings and creating competition that fuels innovation and development of new and enhanced treatments in areas of unmet need.
Sandoz expects to file for regulatory approval for biosimilar aflibercept in the US and EU in the coming months.