Sandoz releases positive results from MYLIGHT Phase III study for biosimilar to aflibercept

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Sandoz, a division of Novartis, announced positive results from the MYLIGHT (NCT04864834) Phase III study, a confirmatory efficacy and safety study for its biosimilar aflibercept. The company, based in Basel, Switzerland, shared the outcomes on Monday. Sandoz is expected to file for regulatory approval for biosimilar aflibercept in the EU and US later this year.

In a comprehensive development program, the biosimilar aflibercept met its primary efficacy endpoint.¹ A press release from Novartis indicated that the biosimilar aflibercept showed therapeutic equivalence in mean change of best corrected visual acuity (BCVA) in comparison to the reference biologic, Eylea®. Within the trial period, researchers reported no clinically meaningful difference in immunogenicity, pharmacokinetics or safety.

Like the reference product, biosimilar aflibercept is a therapeutic for patients with conditions such as neovascular age-related macular degeneration (nAMD) and macular edema. The biologic serves to improve and maintain visual acuity in patients with these and other neovascular retinal diseases.¹

Claire D’Abreu-Hayling, chief scientific officer of Sandoz, acknowledged the positive outcome of the study. “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,” she said in a statement.

Reference:

1. Sandoz announces positive results from Mylight Phase lll study for biosimilar aflibercept. News release. Novartis, August 15, 2023. Accessed August 15, 2023. https://www.novartis.com/news/media-releases/sandoz-announces-positive-results-from-mylight-phase-lll-study-biosimilar-aflibercept