Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Aflibercept · 1 trial · 9 indications
Mean change from baseline to the average of Week 20 and Week 24 in Best-Corrected Visual Acuity (BCVA) by Early Treatment Diabetic Retinopathy Study (ETDRS) letter
| Arm | Type | Description |
|---|---|---|
| Anti-VEGF control arm | ACTIVE_COMPARATOR | Prior to randomization, participants will receive 3 IVT injections of aflibercept over 4-week intervals. Upon randomization, participants will receive 2 mg aflibercept (50 μl of 40 μg/μl solution) IVT on Day 1, Weeks 8, and 16. A sham procedure will also be administered on Day 1. |
| foselutoclax arm | EXPERIMENTAL | Prior to randomization, participants will receive 3 IVT injections of aflibercept over 4-week intervals. Upon randomization, participants will receive 10 μg foselutoclax (50 μl of 0.2 μg/μl solution) IVT on Day 1 and Weeks 8 and 16. 2 mg aflibercept (50 μl of 40 μg/μl solution) will also be administered on Day 1. |
| Name | Type | Description |
|---|---|---|
| Aflibercept | DRUG | Anti-VEGF control |
| foselutoclax | DRUG | Experimental drug |
Inclusion Criteria: * Patients aged ≥18 years. * Patients with nonproliferative DR and DME * Center-involved DME with Central Subfield Thickness (CST) ≥325-900 μm * BCVA in the SE (most affected) of 70 to 30 ETDRS letters (equivalent to 20/40 to 20/250 on the Snellen chart) Exclusion Criteria: * ...
| 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 |
Aflibercept is a small molecule being studied for the treatment of Diabetic Macular Edema (DME), a condition that causes swelling in the macula due to diabetes. It is administered via intravitreal injection and is currently in Phase 2 clinical development as an investigational therapy.
Aflibercept is being developed by Unity Biotechnology, Inc., a company traded on the stock exchange under the ticker symbol UBX. The company is conducting clinical trials to evaluate the safety and efficacy of this drug for patients with Diabetic Macular Edema.
Aflibercept is currently in Phase 2 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The drug is being studied for its potential to treat Diabetic Macular Edema, with one Phase 2 trial already completed.
Aflibercept has been studied in one clinical trial with the identifier NCT06011798, titled "Assess the Efficacy and Safety of Repeat Intravitreal Injections of Foselutoclax (UBX1325) in Patients With DME (ASPIRE)." This Phase 2 trial was completed and enrolled 52 participants in the United States.
Yes, Aflibercept is also known as Foselutoclax, with the alternative name UBX1325. The clinical trial NCT06011798 refers to the drug as Foselutoclax (UBX1325), confirming that these names refer to the same investigational therapy being developed for Diabetic Macular Edema.