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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03466099 | Study of the Intravitreal Plasma Kallikrein Inhibitor, KVD001, in Subjects With Center-involving Diabetic Macular Edema (ciDME) | PHASE2 | COMPLETED | 129 | — | — | Feb 16, 2018 | Oct 10, 2019 | Jan 28, 2021 | 35 | United States |
| NCT02193113 | A Phase I Single Ascending Dose Study of the Intravitreal Plasma Kallikrein Inhibitor KVD001 in Subjects With DME | PHASE1 | COMPLETED | 14 | — | — | Jul 18, 2014 | Jun 4, 2015 | Mar 3, 2017 | 5 | United States |
Change from Baseline in Best Corrected Visual Acuity (BCVA)
| Arm | Type | Description |
|---|---|---|
| KVD001 Injection (high dose) | EXPERIMENTAL | - |
| KVD001 Injection (low dose) | EXPERIMENTAL | - |
| Sham Procedure | SHAM_COMPARATOR | - |
| KVD001 Injection Dose 1 | EXPERIMENTAL | Single 100 microliters (uL) intravitreal injection of KVD001 Injection Dose 1 |
| KVD001 Injection Dose 2 | EXPERIMENTAL | Single 100uL intravitreal injection KVD001 injection Dose 2 |
| KVD001 Injection Dose 3 | EXPERIMENTAL | Single 100uL intravitreal injection of KVD001 injection Dose 3 |
| Name | Type | Description |
|---|---|---|
| KVD001 Injection | DRUG | Intravitreal KVD001 Injection |
| Sham Procedure | OTHER | Sham Procedure |
Inclusion Criteria: * Confirmed diagnosis of Type I or Type II diabetes mellitus (DM). * BCVA of ≥19 letters (\~20/400) and ≤73 letters (\~20/40) in the study eye and ≥34 letters(\~20/200 or better) in the fellow eye. * Presence of ciDME in the study eye defined as CST ≥305 μm in women and ≥320 μm ...
| 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 |