Tags : aflibercept

Formycon with its Partner BIOEQ Plans to Initiate P-III MAGELLAN-AMD

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, the design of the study is developed in collaboration with the USFDA, EMA, PMDA The second program in ophthalmology will aim to strengthen and expand […]Read More

Samsung Bioepis Reports the Initiation of P-III Study for SB15

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 candidates in clinical development, SB11 (ranibizumab) and SB15 (aflibercept). On May 18, 2020, Samsung Bioepis reports 24-week interim results from a P-III study of SB11 […]Read More

Bayer Launches Eylea (aflibercept) Pre-Filled Syringe in Europe

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 Liechtenstein The P-IV ALTAIR study assessing Eylea (aflibercept) with T&E dosing regimens in patients with wet AMD, demonstrated a reduction in injection burden, i.e. up […]Read More

Regeneron Reports Results of Eylea (aflibercept) in P-III PANORAMA Study

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: @2yrs. 75% reduction in vision-threatening events, patients demonstrated greater improvement in the DRSS score from baseline (80% @52wks and 50% @100 wks.) in q8w group […]Read More

Bayer Reports Submission of MAA to the EMA for Pre-Filled

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, myopic CNV Following the state-of-the-art pre-filled syringe of Eylea is approved, it would be the new option for treatment requiring fewer steps to prepare IVT […]Read More

Gene Techno Science Signs an Agreement with Kishi Kasei to

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 by GTS and Fuso Pharmaceutical The collaboration focusses to secure a future revenue base via commercialization of biosimilar of Aflibercept and to gain market share […]Read More

Regeneron’s Eylea (aflibercept) Receives the US FDA’s Approval as a

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 physicians and patients in H2’19 The sterilized prefilled syringe offers the same medication as the currently available Eylea providing ease of administration and is available […]Read More

Bayer Initiates P-III Study of Aflibercept for the Prevention of

Shots: The P-III study will assess the efficacy, safety and tolerability of Aflibercept (intravitreal) in ~100 infants with ROP across 34 countries Bayer & Regeneron collaborated to develop aflibercept whereas Regeneron holds exclusive rights to aflibercept in the US while Bayer retained exclusive marketing rights outside the US with equal profit sharing (Ex-Japan) Aflibercept (marketed […]Read More