Approval Probability
TA Base Rate
Adjusted LOA
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Also known as KVD001 Injection
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 ...
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 |
KVD001 is an investigational small molecule developed for the treatment of diabetic macular edema (DME), a complication of diabetes involving fluid accumulation in the retina. It was studied as an intravitreal injection, meaning it is administered directly into the eye. KVD001 is not approved and remains in clinical development.
KVD001 targets plasma kallikrein, an enzyme involved in the kallikrein-kinin pathway. By inhibiting this enzyme, KVD001 is designed to reduce vascular permeability and inflammation associated with diabetic macular edema. It is a small molecule plasma kallikrein inhibitor delivered via intravitreal injection.
KVD001 is being developed by KalVista Pharmaceuticals, Inc., which trades on the Nasdaq under the ticker KALV. KalVista is the sponsor of the clinical program evaluating KVD001 in diabetic macular edema.
KVD001 is in Phase 2 clinical development. It has completed two trials, a Phase 1 single ascending dose study and a Phase 2 study in center-involving diabetic macular edema. There are currently no active trials. KVD001 is investigational and has not been approved by the FDA.
KVD001 has been evaluated in two completed clinical trials. NCT03466099 was a Phase 2 study of intravitreal KVD001 in patients with center-involving diabetic macular edema, enrolling 129 participants in the United States. NCT02193113 was a Phase 1 single ascending dose study in DME patients, enrolling 14 participants.
Yes, KVD001 Injection is another name for KVD001. Both refer to the same investigational small molecule plasma kallikrein inhibitor developed by KalVista Pharmaceuticals for diabetic macular edema. It is administered as an intravitreal injection directly into the eye.