Sandoz Announces Results from Mylight Phase 3 Study for Biosimilar Aflibercept

Sandoz released positive results from the MYLIGHT phase 3 confirmatory efficacy and safety study for its biosimilar aflibercept for wet macular degeneration (AMD).

The Mylight phase 3 confirmatory efficacy and safety study (ClinicalTrials.gov NCT04864834) 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 (aflibercept 2 mg; Regeneron). Safety, immunogenicity, and pharmacokinetics results further confirm that there is no clinically meaningful difference between the products, according to Sandoz, which is a division of Novartis.

The reference product Eylea is indicated to improve and subsequently maintain visual acuity in patients with wet AMD, diabetic macular edema (DME), macular edema secondary to retinal vein occlusion (RVO), and other specific neovascular retinal diseases. 

“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," Claire D’Abreu-Hayling, Chief Scientific Officer, Sandoz, said in a company news release. "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 has eight marketed biosimilars and a 24 assets in various stages of development. 

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