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Also known as 4D-150 IVT, 4D-150 IVT (3x10^10 vg)
4D-150 · 5 trials · 6 indications
The minimum and maximum values are: 0 to 100 The higher the value the better the result
| Arm | Type | Description |
|---|---|---|
| 4D-150 IVT (3x10^10 vg/eye) | EXPERIMENTAL | - |
| Active Comparator (AFLB) 2mg IVT | ACTIVE_COMPARATOR | - |
| 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 (3x10^10 vg) | 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 |
| EYELEA ® (aflibercept) Injection 2 mg (0.05mL) | BIOLOGICAL | EYLEA ® (aflibercept) will be administered at applicable visits |
| 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 |
5.2 Inclusion Criteria Individuals eligible to participate in the trial must meet the following inclusion criteria: General Inclusion Criteria 1. Signed informed consent before any protocol-specified assessment is performed 2. Ability and willingness to comply with the protocol-specified procedur...
Top 16 of 17 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| EyePoint, Inc. | EYPT | 2 | PHASE3 | EYP-1901 |
| 4D Molecular Therapeutics, Inc. | FDMT | 2 | PHASE3 | 4D-150, EYELEA |
| Regeneron Pharmaceuticals, Inc. | REGN | 1 | PHASE3 | Aflibercept |
| Hoffmann-La Roche | RHHBY | 6 | PHASE3 | Ranibizumab, Susvimo, RO7497372, RO7823653, Faricimab |
| Merck & Co., Inc. | MRK | 2 | PHASE3 | MK-8748 |
| AbbVie, Inc. | ABBV | 2 | PHASE2 | Surabgene Lomparvovec |
| Outlook Therapeutics, Inc. | OTLK | 1 | PHASE3 | ONS-5010 |
| Kodiak Sciences, Inc. | KOD | 1 | PHASE3 | Tabirafusp tedromer |
| Alvotech | ALVO | 1 | PHASE3 | AVT29 |
| Kiora Pharmaceuticals, Inc. | KPRX | 1 | PHASE2 | KIO-104 |
| REGENXBIO, Inc. | RGNX | 1 | PHASE2 | RGX-314 |
| BioAge Labs, Inc. | BIOA | 1 | PHASE2 | BGE-102 |
| Ocugen Inc | OCGN | 1 | PHASE1 | OCU200 |
| Surrozen Inc | SRZN | 1 | PHASE1 | SZN-8141 |
| Adverum Biotechnologies, Inc. | ADVM | 1 | - | ADVM-022 |
| Bayer | BAYRY | 1 | - | Aflibercept |
4D-150 is an investigational intravitreal therapy developed by 4D Molecular Therapeutics for retinal diseases driven by VEGF. It is being studied in diabetic macular edema and macular neovascularization secondary to age-related macular degeneration, including neovascular (wet) AMD. It is a monoclonal antibody-based product given as a single intravitreal injection in the trials listed.
4D-150 is being studied as a treatment for diabetic macular edema, a VEGF-driven retinal condition. A Phase 3 trial, NCT07867080, is recruiting adults 18 years and older with DME across the United States, China, and Japan, with planned enrollment of 514 participants. An earlier Phase 2 trial in DME and diabetic retinopathy, NCT05930561, enrolled 72 patients.
4D-150 targets VEGF, the vascular endothelial growth factor protein that drives abnormal blood vessel growth and leakage in retinal disease. By binding VEGF, the monoclonal antibody aims to counter the neovascularization and fluid accumulation seen in diabetic macular edema and neovascular age-related macular degeneration.
4D-150 is being developed by 4D Molecular Therapeutics, Inc., which trades under the ticker FDMT. The company is running the clinical program for the asset in ophthalmology, with Phase 3 trials underway in diabetic macular edema and neovascular age-related macular degeneration.
4D-150 is in Phase 3 clinical development. Two Phase 3 trials are currently recruiting: NCT07867080 in diabetic macular edema and NCT07064759 in neovascular age-related macular degeneration. A third Phase 3 trial, NCT06864988, is active but no longer recruiting. 4D-150 holds an RMAT designation from the FDA and remains investigational.
4D-150 is being evaluated in four registered trials. Phase 3 studies include NCT07867080 in diabetic macular edema, NCT07064759 in neovascular AMD across 18 countries, and NCT06864988 in macular neovascularization secondary to AMD in the United States and Canada. A Phase 2 trial, NCT05930561, studied DME and diabetic retinopathy.
Yes. 4D-150 IVT is another name for 4D-150, referring to intravitreal administration of the therapy. Dose-specific labels such as 4D-150 IVT (3E10 vg/eye) and 4D-150 IVT (3x10^10 vg) describe the same investigational product given at different vector genome doses per eye.