Sandoz, a global leader in off-patent medicines, today announced positive results from the Mylight Phase III confirmatory efficacy and safety study for its biosimilar aflibercept in patients with wet macular degeneration, a significant step forward in the company’s efforts to address this unmet medical need.
Mylight (NCT04864834) is part of a complete biosimilar development programme that includes analytical, preclinical, and clinical trials. The primary effectiveness endpoint of the Mylight Phase III confirmatory efficacy and safety study was met, with 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®. The results of safety, immunogenicity, and pharmacokinetics demonstrate that there is no clinically relevant difference between the products.
Next Step
Sandoz anticipates filing regulatory applications for biosimilar aflibercept in the United States and the European Union by Q3~Q4 2023
The reference product Eylea® is used to enhance and then maintain visual acuity in individuals with Neovascular Age-Related Macular Degeneration (nAMD), Diabetic Macular Edoema, Retinal Vein Occlusion (RVO), and other specialised neovascular retinal disorders. These disorders induce centre vision blur and, if left untreated, can result in permanent vision loss. One of the most common causes of blindness, AMD affects over 200 million individuals globally.
“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.”-said Claire D’Abreu-Hayling, Chief Scientific Officer, Sandoz.
About Sandoz:
Sandoz is dedicated to assisting millions of patients by offering affordable access to vital and potentially life-changing biologic medications in a variety of therapeutic areas such as ophthalmology, immunology, oncology, supportive care, and endocrinology. With eight marketed biosimilars and another 24 assets in various stages of development, it has a leading global portfolio. 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 improved treatments in areas of unmet need since launching the first biosimilar in Europe in 2006.
About aflibercept:
Aflibercept is a recombinant fusion protein that inhibits aberrant vessel formation by binding to vascular endothelial growth factor A (VEGF-A) and placental growth factor (PlGF). Aflibercept is injected into the eye of individuals with neovascular retinal illnesses such as neovascular age-related macular degeneration (nAMD), diabetic macular edoema (DME), or retinal vein occlusion (RVO) to improve visual acuity and slow disease progression.
About Mylight Clinical trial for Biosimilar Aflibercept in patient with wet nAMD:
Mylight is a randomised, double-blind, parallel 2-arm study that enrolled 485 individuals from 16 different countries. The Mylight study was done in nAMD (wet/exudative) because it is a sensitive enough indication to show treatment equivalence to the reference biologic, Eylea®.2 Neovascular AMD patients were randomly assigned to receive either biosimilar aflibercept or Eylea® for 48 weeks, followed by a four-week safety follow-up period. The trial lasted 52 weeks in total. The primary endpoint is the mean change in best corrected visual acuity (BCVA) score from baseline to week 8, as measured by an EDTRS.
Eylea® is a trademark of Bayer AG and in the US of Regeneron Pharmaceuticals, Inc.
