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4D-150 IVT · 4 trials · 5 indications
| Arm | Type | Description |
|---|---|---|
| 4D-150 IVT (3E10 vg/eye) | EXPERIMENTAL | - |
| Aflibercept (AFLB) 2 mg IVT | ACTIVE_COMPARATOR | - |
| 4D-150 Part 1 Dose Confirmation Dose Level 1 | EXPERIMENTAL | 4D-150 will be administered at the assigned dose level as a single dose IVT injection on Day 1. |
| 4D-150 Part 1 Dose Confirmation Dose Level 2 | EXPERIMENTAL | 4D-150 will be administered at the assigned dose level as a single dose IVT injection on Day 1. |
| 4D-150 Part 2 Dose Expansion Dose Level 1 | EXPERIMENTAL | 4D-150 will be administered at the assigned dose level as a single dose IVT injection on Day 1. |
| 4D-150 Part 2 Dose Expansion Dose Level 2 | EXPERIMENTAL | 4D-150 will be administered at the assigned dose level as a single dose IVT injection on Day 1. |
| 4D-150 Part 2 Dose Expansion Control | ACTIVE_COMPARATOR | Aflibercept at a fixed regimen will be administered. |
| 4D-150 Dose Escalation up to 4 dose levels | EXPERIMENTAL | 4D-150 will be administered at the assigned dose level as a single dose IVT injection on Day 1. |
| 4D-150 Dose Expansion Dose 1 | EXPERIMENTAL | 4D-150 will be administered at the assigned dose level as a single dose IVT injection on Day 1. |
| 4D-150 Dose Expansion Dose 2 | EXPERIMENTAL | 4D-150 will be administered at the assigned dose level as a single dose IVT injection on Day 1. |
| 4D-150 Dose Expansion Control | ACTIVE_COMPARATOR | Aflibercept at a fixed regimen will be administered. |
| 4D-150 Steroid Optimization | EXPERIMENTAL | 4D-150 will be administered at the assigned dose level as a single dose IVT injection on Day 1. |
| 4D-150 Population Extension Dose 1 | EXPERIMENTAL | 4D-150 will be administered at the assigned dose level as a single dose IVT injection on Day 1. |
| 4D-150 Population Extension Dose 2 | EXPERIMENTAL | 4D-150 will be administered at the assigned dose level as a single dose IVT injection on Day 1. |
| 4D-150 Population Extension Dose 3 | EXPERIMENTAL | 4D-150 will be administered at the assigned dose |
| 4D-150 Contralateral Eye Dose | EXPERIMENTAL | 4D-150 will be administered at the assigned dose level as a single dose IVT injection on Day 1. |
| 4D-150 Vector Shedding Dose | EXPERIMENTAL | 4D-150 will be administered at the assigned dose level as a single dose IVT injection on Day 1. |
| Name | Type | Description |
|---|---|---|
| 4D-150 IVT (3E10 vg/eye) | BIOLOGICAL | If randomized to the 4D-150 treatment arm, 4D-150 will be administered at the assigned dose level as a single dose IVT injection on Day 1 |
| EYLEA® (aflibercept) Injection 2 mg (0.05mL) | BIOLOGICAL | Eylea (aflibercept) will be administered at applicable visits |
| 4D-150 IVT | BIOLOGICAL | 4D-150: AAV-based gene therapy comprised of miRNA targeting VEGF-C and codon-optimized sequence encoding aflibercept. |
| Aflibercept IVT | BIOLOGICAL | Commercially available Active Comparator |
Inclusion Criteria: * ≥50 years of age at time of consent * MNV secondary to nAMD with IVT anti-VEGF treatment history in the study eye, defined as EITHER: 1. Treatment naïve, i.e. no prior IVT anti-VEGF therapy OR 2. Previously treated with no more than 4 IVT anti-VEGF injections due to nAMD ...
4D-150 IVT is an investigational intravitreal gene therapy being developed for neovascular (wet) age-related macular degeneration (nAMD), diabetic macular edema, and macular neovascularization secondary to age-related macular degeneration. It is administered as a single intravitreal injection and is currently in Phase 2 clinical development.
4D-150 IVT is being developed by 4D Molecular Therapeutics, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker symbol FDMT. The company is conducting clinical trials of 4D-150 IVT in patients with retinal diseases including wet age-related macular degeneration and diabetic macular edema.
4D-150 IVT is in Phase 2 clinical development. It has received Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA. The drug is investigational and has not been approved by regulatory authorities for commercial use.
4D-150 IVT is being studied in multiple trials. NCT05197270 is a Phase 1 trial in wet age-related macular degeneration with 215 participants. NCT05930561 is a Phase 2 trial in diabetic macular edema with 72 participants. NCT06864988 and NCT07064759 are Phase 3 trials in macular neovascularization, each enrolling 480 participants.
Yes, 4D-150 IVT (3E10 vg/eye) is an alternative name for the same drug, 4D-150 IVT. The designation 3E10 vg/eye refers to a specific dose of 3 x 10^10 vector genomes per eye used in clinical trials of the therapy.
4D-150 IVT is not FDA approved. It is an investigational drug currently in clinical development for retinal diseases. The FDA has granted it Regenerative Medicine Advanced Therapy (RMAT) designation, which is intended to expedite development and review of regenerative medicine therapies.