Sandoz has plans to begin a late-stage clinical development programme to assess its proposed biosimilar aflibercept, which is developed to improve visual acuity in retinal disease patients.
Aflibercept binds and inhibits ocular vascular endothelial growth factor A (VEGF-A). It also hinders abnormal blood vessels growth in the choroid, which effect visual function.
The drug improves visual acuity in patients with neovascular retinal diseases, such as neovascular age-related macular degeneration (nAMD), diabetic macular oedema (DME), and retinal vein occlusion (RVO).
A Novartis division, Sandoz will evaluate its biosimilar aflibercept in a Phase III confirmatory efficacy and safety trial, MYLIGHT.
The study is part of a biosimilar development programme for analytical, preclinical and clinical data. MYLIGHT will validate if the proposed biosimilar’s efficacy is equivalent to and its safety is comparable to the reference medicine, Eylea, in nAMD patients.
Designed as a randomised, double-blind, parallel two-arm study, MYLIGHT will enrol approximately 460 patients across 20 countries. The first patient in the trial is set to be recruited shortly.
Participants will receive either biosimilar aflibercept or Eylea over 48 weeks. The mean change in best corrected visual acuity (BCVA) score from baseline to week 8 will be evaluated as the primary endpoint using a standard test chart (EDTRS).
Sandoz Biopharmaceuticals Development global head Florian Bieber said: “nAMD accounts for 10% of all age-related macular degeneration cases, but is responsible for 90% of AMD-related blindness.
“Aflibercept is a key treatment in ophthalmology. The initiation of this study marks an important milestone in the development of our biosimilar aflibercept.”
Sandoz worked with various regulatory agencies to develop this development programme of biosimilar aflibercept and expects the results from MYLIGHT to support submissions for regulatory approval.
The company has a portfolio of eight marketed biosimilars and an additional 15 in development, including biosimilar denosumab to treat osteoporosis.