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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 an investigational medicine being studied for the treatment of neovascular (wet) age-related macular degeneration (AMD), a condition that causes rapid vision loss due to abnormal blood vessel growth under the retina. It is currently in Phase 3 clinical development and has not been approved by regulatory authorities.
AVT06 is a small molecule designed to treat neovascular (wet) AMD. The specific molecular target of AVT06 is not disclosed in the available clinical trial information, so its exact mechanism of action is not publicly detailed.
AVT06 is being developed by Alvotech, a biopharmaceutical company listed on the NASDAQ under the ticker symbol ALVO. The company is conducting clinical trials to evaluate the safety and efficacy of AVT06 for the treatment of neovascular (wet) AMD.
AVT06 is in Phase 3 clinical development. A Phase 3 trial has been completed, but the drug remains investigational and has not yet received regulatory approval. Further development and regulatory review are required before it can be made available to patients.
AVT06 has one completed Phase 3 clinical trial registered as NCT05155293, titled 'Clinical Study to Compare Efficacy and Safety of AVT06 and EU-Eylea (ALVOEYE)'. The trial enrolled 413 participants with neovascular (wet) AMD across Czechia, Georgia, Japan, Latvia, and Slovakia.
AVT06 is not the same as Eylea. AVT06 is an investigational drug being compared to EU-Eylea in a clinical trial (NCT05155293) to evaluate its efficacy and safety. The trial is designed to assess whether AVT06 is comparable to the reference product, but AVT06 itself is a distinct, unapproved medicine.