The trial showed therapeutic equivalence in mean change of best corrected visual acuity (BCVA) from baseline to week eight between aflibercept and the reference biologic, Eylea
Sandoz reports positive results from late-stage trial of biosimilar aflibercept. (Credit: Harpreet Singh on Unsplash)
Sandoz, part of the Novartis Group, announced that its biosimilar aflibercept has met the primary efficacy endpoint in the MYLIGHT Phase 3 confirmatory trial of patients living with wet macular degeneration.
Aflibercept is a recombinant fusion protein that targets vascular endothelial growth factor A (VEGF-A) and placental growth factor (PlGF) to inhibit abnormal growth of vessels.
The trial showed therapeutic equivalence in mean change of best corrected visual acuity (BCVA) from baseline to week eight between aflibercept and the reference biologic, Eylea.
The reference product Eylea is intended to improve and maintain visual acuity in patients with Diabetic Macular Edema, Neovascular Age-Related Macular Degeneration (nAMD), macular edema secondary to Retinal Vein Occlusion (RVO), and other neovascular retinal diseases.
Additionally, the safety, immunogenicity, and pharmacokinetics findings further show no clinically meaningful difference between the products.
Sandoz chief scientific officer Claire D’Abreu-Hayling said: “This important milestone, confirming the 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.”
Mylight is a randomised, double-masked, parallel 2-arm study, which enrolled 485 patients from 16 nations. Its total duration was 52 weeks.
The trial randomised Neovascular AMD patients in a 1:1 ratio to get biosimilar aflibercept or Eylea for 48 weeks followed by a safety follow-up period of four weeks.
The primary endpoint was defined as the mean change in BCVA score from baseline to week eight, using a standard test chart (EDTRS).
Sandoz is planning to file for regulatory clearance for biosimilar aflibercept in the US and European Union in the coming months.
The generic pharmaceuticals and biosimilars company has in total eight marketed biosimilars and an additional 24 assets in various development phases.