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Also known as AVT06 (proposed aflibercept biosimilar)
AVT06 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| AVT06 (proposed aflibercept biosimilar) | EXPERIMENTAL | Patients will receive 1 IVT injection of AVT06 every 4 weeks for the first 3 consecutive doses, followed by 1 IVT injection every 8 weeks through study completion. |
| Eylea® (Aflibercept) | EXPERIMENTAL | Patients will receive 1 IVT injection of Eylea® every 4 weeks for the first 3 consecutive doses, followed by 1 IVT injection every 8 weeks through study completion. |
| Name | Type | Description |
|---|---|---|
| AVT06 (proposed aflibercept biosimilar) | DRUG | Patients will receive IVT injections of AVT06 |
| Eylea® (Aflibercept) | DRUG | Patients will receive IVT injections of Eylea® |
Inclusion Criteria: * Subject must be ≥50 years of age, at the time of signing the informed consent. * Subjects must be diagnosed with neovascular (wet) AMD in the study eye. * Subjects must have active, treatment naïve, subfoveal CNV lesions secondary to neovascular (wet) AMD. * Willingness and ab...
AVT06 is a proposed aflibercept biosimilar developed by Alvotech for the treatment of neovascular (wet) age-related macular degeneration (AMD). It is an investigational ophthalmology product that has been studied in a Phase 3 clinical trial comparing it with EU-Eylea, the European reference aflibercept product.
AVT06 is being developed for neovascular (wet) age-related macular degeneration, the condition studied in its clinical program. Wet AMD is an ophthalmology indication in which abnormal blood vessel growth damages the macula. AVT06 is intended as a biosimilar to aflibercept, a therapy already used in this indication.
AVT06 is a proposed biosimilar to aflibercept, a protein that acts as a vascular endothelial growth factor (VEGF) inhibitor. By mimicking aflibercept, AVT06 is designed to bind VEGF and reduce the abnormal vessel growth and leakage that drive neovascular (wet) AMD. Its molecular target is aflibercept's VEGF pathway.
AVT06 is developed by Alvotech, which trades on the Nasdaq under the ticker ALVO. Alvotech is a biosimilar developer, and AVT06 is its proposed aflibercept biosimilar candidate for ophthalmology, studied against EU-Eylea as the reference product in its Phase 3 program.
AVT06 is in Phase 3 development. Its single registered trial, NCT05155293, is a completed Phase 3 study, and AVT06 is not described as approved. It remains an investigational biosimilar candidate rather than a marketed product.
AVT06 has been studied in one Phase 3 trial, NCT05155293, titled "Clinical Study to Compare Efficacy and Safety of AVT06 and EU-Eylea (ALVOEYE)." The completed, randomized, double-blind, controlled trial enrolled 413 participants with neovascular (wet) AMD across Czechia, Georgia, Japan, Latvia, and Slovakia, and included adults aged 50 years and older.
AVT06 is a proposed aflibercept biosimilar, meaning it is developed as a comparable version of aflibercept rather than a novel molecule. It is also referred to as AVT06 (proposed aflibercept biosimilar). In its Phase 3 trial, AVT06 was compared with EU-Eylea, the European reference aflibercept product.