Positive results from Mylight Phase lll study for biosimilar aflibercept
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.
Sandoz expects to file for regulatory approval for biosimilar aflibercept in the US and EU in the coming months..
The U.S. patents for Lucentis and Eylea expired in 2020, and their European patents expired in 2022 and will expire in 2025 respectively.
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