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Also known as AVT29 (proposed aflibercept HD biosimilar)
AVT29 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| AVT29 (proposed aflibercept HD biosimilar) | EXPERIMENTAL | Participants will receive 1 IVT injection of AVT29 at baseline and every 4 weeks for 2 consecutive monthly visits (at Week 4 and Week 8), followed by 1 IVT injection every 8 to 16 weeks based on DRM criteria through study completion. |
| Eylea HD (aflibercept HD) | ACTIVE_COMPARATOR | Participants will receive 1 IVT injection of Eylea HD at baseline and every 4 weeks for 2 consecutive monthly visits (at Week 4 and Week 8), followed by 1 IVT injection every 8 to 16 weeks based on DRM criteria through study completion. |
| Name | Type | Description |
|---|---|---|
| AVT29 (proposed aflibercept HD biosimilar) | DRUG | Patients will receive IVT injections of AVT29 |
| Eylea HD (aflibercept HD) | DRUG | Patients will receive IVT injections of Eylea HD |
Main Inclusion Criteria: * Participant is ≥18 years old at the time of signing the ICF. * Participant is willing and able to comply with all study procedures and likely to complete the study, based on the investigator's judgment. * Participant has a diagnosis of DME secondary to DM with central inv...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| EyePoint, Inc. | EYPT | 2 | PHASE3 | EYP-1901, Aflibercept |
| Regeneron Pharmaceuticals, Inc. | REGN | 1 | PHASE3 | Aflibercept |
| Oculis Holding AG | OCS | 2 | PHASE3 | Dexamethasone, Vehicle |
| AbbVie, Inc. | ABBV | 3 | PHASE2 | ABBV-RGX-314 Dose 1, Steroid, Aflibercept |
| Outlook Therapeutics, Inc. | OTLK | 1 | PHASE3 | bevacizumab |
| 4D Molecular Therapeutics, Inc. | FDMT | 1 | PHASE2 | 4D-150 IVT, Aflibercept IVT |
| Alvotech | ALVO | 1 | PHASE3 | AVT29, Eylea HD |
| Kiora Pharmaceuticals, Inc. | KPRX | 1 | PHASE2 | KIO-104 |
| REGENXBIO, Inc. | RGNX | 1 | PHASE2 | RGX-314 Dose 1, RGX-314 Dose 2, Aflibercept |
| Ocugen Inc | OCGN | 1 | PHASE1 | OCU200 |
| Adverum Biotechnologies, Inc. | ADVM | 1 | - | ADVM-022 |
AVT29 is an investigational biosimilar being developed for diabetic macular edema, a condition that causes vision loss due to fluid buildup in the macula. It is currently in Phase 3 clinical development and has not been approved by regulatory authorities.
AVT29 is a proposed biosimilar to aflibercept HD, which targets vascular endothelial growth factor (VEGF). By binding to VEGF, it is intended to reduce abnormal blood vessel growth and leakage in the eye, which are key drivers of diabetic macular edema.
AVT29 is being developed by Alvotech, a biopharmaceutical company listed on the Nasdaq under the ticker ALVO. Alvotech specializes in biosimilars and is conducting a Phase 3 clinical trial to evaluate AVT29 in patients with diabetic macular edema.
AVT29 is in Phase 3 clinical development. It is an investigational drug and has not yet been approved by the FDA or other regulatory agencies. The ongoing Phase 3 trial is actively recruiting participants to assess its efficacy and safety compared to Eylea HD.
AVT29 is being studied in a Phase 3 clinical trial with the identifier NCT07489131. This randomized, double-blind, active-controlled study is comparing AVT29 to Eylea HD in 256 participants with diabetic macular edema. The trial is currently recruiting and is being conducted in Hungary.
AVT29 is not the same as Eylea HD; it is a proposed biosimilar to Eylea HD (aflibercept HD). Biosimilars are designed to be highly similar to an approved biologic and are intended to have no clinically meaningful differences in safety and efficacy. AVT29 is still under investigation.