Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
KVD001 · 2 trials · 1 indication
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 |
KVD001 is an investigational small molecule being developed for diabetic macular edema (DME), a condition that causes swelling in the macula of the eye due to diabetes. It is administered by intravitreal injection and is currently in clinical development, though it has not been approved by the FDA.
KVD001 is a plasma kallikrein inhibitor. It works by inhibiting plasma kallikrein, an enzyme involved in the inflammatory and vascular pathways that contribute to diabetic macular edema. By blocking this target, KVD001 aims to reduce vascular leakage and swelling in the retina.
KVD001 is being developed by KalVista Pharmaceuticals, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol KALV. The company is conducting clinical trials to evaluate the safety and efficacy of KVD001 in patients with diabetic macular edema.
KVD001 is in Phase 2 clinical development. It has completed a Phase 1 study and a Phase 2 study, both of which are finished. The drug remains investigational and has not received FDA approval, meaning it is still being studied for safety and effectiveness in treating diabetic macular edema.
KVD001 has been studied in two completed clinical trials. The first, NCT02193113, was a Phase 1 single ascending dose study in 14 subjects with diabetic macular edema. The second, NCT03466099, was a Phase 2 study in 129 subjects with center-involving diabetic macular edema. Both trials were conducted in the United States.
KVD001 is a unique investigational compound developed by KalVista Pharmaceuticals. It is not known to be the same as any other marketed drug. It is a small molecule plasma kallikrein inhibitor specifically designed for intravitreal administration to treat diabetic macular edema.