Shots: The company starts enrolling patients in the P-III MYLIGHT study to evaluate the safety and efficacy of biosimilar aflibercept vs Eylea in patients with nAMD for 48wks. The study […]readmore
Tags : aflibercept
Shots: The company has completed a P-I trial that assessed ALT-L9 vs Eylea in 28 patients in a ratio (1:1) with neovascular (wet) AMD. The trial was conducted at 4 […]readmore
Shots: Celltrion has launched a global P-III clinical trial of CT-P42 which is an investigational biosimilar candidate referencing Regeneron’s Eylea (aflibercept) The study will enroll 300 patients with DME and […]readmore
Shots: BIOEQ will sponsor the P-III study which will assess the FYB203 vs Eylea in patients with neovascular age-related macular degeneration (nAMD) to evaluate its efficacy, safety and immunogenicity. Additionally, […]readmore
Shots: The P-III study will compare the efficacy, safety, PK, and immunogenicity between SB15 and Eylea in 446 patients with neovascular age-related macular degeneration The company has two ophthalmology biosimilar […]readmore
Shots: The EMA has approved Bayer’s Eylea® (aflibercept) injection pre-filled syringe with the EC’s decision applies to all 27 EU member states as well as the UK, Iceland, Norway and […]readmore
Shots: The P-III PANORAMA study involves assessing Eylea [inj. 2mg (0.05ml), q8w/q16w] vs sham in 402 patients with moderately severe to severe NPDR without DME The P-III PANORAMA study results: […]readmore
Shots: Bayer has applied for the approval to the EMA for its pre-filled syringe to administer Eylea for five retinal indications including neovascular wet AMD, macular edema following RVO, DME, […]readmore
Shots: GTS and Kishi Kasei will jointly develop biosimilar of Aflibercept and will form a manufacturing process for the drug substance utilizing high-yield protein-producing cell lines, which were jointly developed […]readmore
Shots: The US FDA has approved the Chemistry, Manufacturing and Controls (CMC) Prior-Approval Supplement (PAS) for the Eylea (2mg, single dose) sterilized prefilled syringe with its expected availability to the […]readmore