Sandoz shares positive results from MYLIGHT phase 3 study
Sandoz has announced positive results from the phase 3 MYLIGHT confirmatory efficacy and safety study for its biosimilar aflibercept, for the treatment of patients with wet macular degeneration, part of the company’s efforts to address this area of unmet medical need.
The MYLIGHT study was part of a biosimilar development programme, with this section aiming to confirm the drug’s efficacy and safety, as well as meeting its primary endpoint demonstrating therapeutic equivalence in mean change of best corrected visual activity (BCVA) from baseline until week 6 between the biosimilar aflibercept and its reference biologic, Eylea.
The biosimilar’s safety, immunogenicity and pharmacokinetics show no clinical difference between the two products.
Claire D’Abreu-Hayling, chief scientific officer at Sandoz, commented: “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.”
The company plans to file for regulatory approval for its biosimilar in the US and EU within the next few months.
Clinical stage biopharmaceutical company Nuvectis Pharma has announced the initiation of a phase 1a dose …
Sosei Heptares has announced that its partner, Neurocrine Biosciences, has initiated its phase 1 first-in-human …