Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05989126 | Study to Evaluate an 8 mg Aflibercept (EYLEA®) Prefilled Syringe (PFS) | PHASE3 | COMPLETED | 35 | — | — | Apr 15, 2024 | May 31, 2024 | May 28, 2026 | 2 | United States |
Participants received a single dose of study drug, administered in the selected study eye with the PFS by a retina specialist. Physician assessed successful aflibercept preparation and administration with the PFS.
| Arm | Type | Description |
|---|---|---|
| 8 mg Dose | EXPERIMENTAL | Only 1 eye will be selected as the study eye by the investigator. Patients will receive a single dose utilizing the PFS. |
| Name | Type | Description |
|---|---|---|
| aflibercept 8 mg PFS | DRUG | Sterile aqueous solution in a single-dose PFS administered by intravitreal (IVT) injection |
Key Inclusion Criteria: 1. Patient must have diabetic macular edema (DME) or neovascular "wet" age-related macular degeneration (nAMD) in the study eye 2. Study eye considered by the retina specialist to be eligible for treatment with 8 mg aflibercept Key Exclusion Criteria: 1. Any active intraoc...
| 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 |