Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as KSI-301, Tarcocimab
Tarcocimab tedromer · 4 trials · 4 indications
Mean change in BCVA from Day 1 to Year 1
Early Treatment Diabetic Retinopathy Diabetic Retinopathy Severity Scale (ETDRS DRSS), on a scale from 10 to 90, where lower scores represent better outcomes.
Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity.
BCVA as a continuous variable measured at each study visit using the Early Treatment Diabetic Retinopathy Study (ETDRS) BCVA approach.
BCVA as a continuous variable measured at each study visit using the Early Treatment Diabetic Retinopathy Study (ETDRS) BCVA approach.
| Arm | Type | Description |
|---|---|---|
| Tarcocimab tedromer 5 mg (KSI-301) | EXPERIMENTAL | Intravitreal injection of tarcocimab tedromer once every 4 weeks for 4 monthly doses followed by individualized dosing every 4 to 24 weeks. |
| Tabirafusp tedromer 5 mg (KSI-501) | EXPERIMENTAL | Intravitreal injection of tabirafusp tedromer once every 4 weeks for 4 monthly doses followed by every-8-week dosing with additional individualized dosing (up to monthly dosing) |
| Aflibercept 2 mg | ACTIVE_COMPARATOR | Intravitreal injection of aflibercept once every 4 weeks for 3 monthly doses followed by every-8-week dosing |
| Tarcocimab 5 mg (Treatment Group A) | EXPERIMENTAL | Tarcocimab 5 mg via intravitreal injection at Day 1, Week 4, Week 8, Week 20, and Week 44. |
| Treatment Group B | SHAM_COMPARATOR | Sham injection on the same schedule as Treatment Group A |
| KSI-301 (Treatment Group A) | EXPERIMENTAL | Intravitreal injection of KSI-301 (5 mg) at Day 1 once every 4 weeks via intravitreal injection through Week 44. |
| Aflibercept (Treatment Group B) | ACTIVE_COMPARATOR | Intravitreal injection of aflibercept (2 mg) once every 4 weeks for 3 monthly doses followed by intravitreal injection of aflibercept (2 mg) once every 8 weeks from Week 16 to Week 44. Sham injections will be administered at each monthly visit where an active treatment is not administered. |
| KSI-301 (Arm A) | EXPERIMENTAL | Intravitreal injection of KSI-301 (5 mg) at Day 1, Week 4, and once every 8 weeks through Week 20 followed by an individualized dosing regimen of Intravitreal injection of KSI-301 (5 mg) from Week 24 to Week 44. In the Extension Phase, participants randomized to KSI-301 (5 mg) in the Primary Study will continue to receive KSI-301 (5 mg) based on protocol-defined disease activity criteria. |
| Aflibercept (Arm B) | ACTIVE_COMPARATOR | Intravitreal injection of aflibercept (2 mg) once every 4 through Week 20 followed by an individualized dosing regimen of Intravitreal injection of Aflibercept (2 mg) once every 4 weeks from Week 24 to Week 44. In the Extension Phase, participants randomized to aflibercept in the Primary Study will cross over to treatment with KSI-301 (5 mg). They will receive their first dose of KSI-301 (5 mg) at Week 48 and will receive additional treatment with KSI-301 (5 mg) based on protocol-defined disease activity criteria. |
| Name | Type | Description |
|---|---|---|
| Tarcocimab tedromer | DRUG | Intravitreal injection |
| Tabirafusp tedromer | DRUG | Intravitreal injection |
| Aflibercept | DRUG | Intravitreal injection |
| Tarcocimab | DRUG | Intravitreal injection |
| Sham injection | OTHER | The sham injection is a procedure that mimics an intravitreal injection. It involves pressing the blunt end of an empty syringe (without a needle) against the anesthetized eye. It is performed to maintain masking of the study. |
| KSI-301 | DRUG | Intravitreal Injection |
| Sham Procedure | OTHER | The sham is a procedure that mimics an intravitreal injection. It involves pressing the blunt end of an empty syringe (without a needle) against the anesthetized eye. It will be administered to participants in both treatments arms at applicable visits to maintain masking. |
Inclusion Criteria: * Active, treatment-naïve choroidal neovascularization (CNV) secondary to AMD, including subfoveal, juxtafoveal, and extrafoveal lesions, or retinal angiomatous proliferations (RAP) lesions with a CNV component that affects the central subfield, as evidenced by FA or OCT in the ...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| AbbVie, Inc. | ABBV | 7 | PHASE3 | Surabgene Lomparvovec, RGX-314, ABBV-6628 |
| Ocular Therapeutix Inc | OCUL | 3 | PHASE3 | OTX-TKI |
| 4D Molecular Therapeutics, Inc. | FDMT | 3 | PHASE3 | 4D-150 |
| Regeneron Pharmaceuticals, Inc. | REGN | 2 | PHASE3 | Aflibercept, Pozelimab, Cemdisiran |
| Novartis AG Sponsored ADR | NVS | 5 | PHASE2 | Iptacopan, GT005, FWY003 |
| EyePoint, Inc. | EYPT | 2 | PHASE3 | EYP-1901 |
| Kodiak Sciences, Inc. | KOD | 1 | PHASE3 | Tarcocimab tedromer, Tabirafusp tedromer |
| Hoffmann-La Roche | RHHBY | 10 | PHASE3 | Ranibizumab, Susvimo, RO7965032, OpRegen, Faricimab |
| Outlook Therapeutics, Inc. | OTLK | 1 | PHASE3 | ONS-5010 |
| Adverum Biotechnologies, Inc. | ADVM | 4 | PHASE3 | Ixo-vec, ADVM-022 |
| Apellis Pharmaceuticals, Inc. | APLS | 1 | PHASE2 | APL-3007 |
| Amgen Inc. | AMGN | 1 | PHASE3 | ABP 938, Aflibercept |
| Johnson & Johnson | JNJ | 1 | PHASE2 | JNJ-81201887 |
| Ocugen Inc | OCGN | 1 | PHASE3 | OCU410 |
| Alcon AG | ALC | 1 | PHASE1 | AR-14034 |
| Sanofi SA Sponsored ADR | SNY | 1 | PHASE1 | SAR402663 |
| Arrowhead Pharmaceuticals, Inc. | ARWR | 1 | PHASE1 | ARO-033 |
| Bayer | BAYRY | 2 | - | Aflibercept |
Tarcocimab tedromer is an investigational monoclonal antibody being developed by Kodiak Sciences Inc for the treatment of wet age-related macular degeneration, an eye condition also known as neovascular AMD. It is administered as an intravitreal therapy and is currently in Phase 3 clinical development. It has not been approved by the FDA.
Tarcocimab tedromer is being studied for the treatment of neovascular, or wet, age-related macular degeneration, a form of AMD driven by abnormal blood vessel growth in the retina. The Phase 3 DAYBREAK trial is evaluating its efficacy and safety in adults with this condition. It remains investigational and is not approved for any use.
Tarcocimab tedromer targets VEGF-A, vascular endothelial growth factor A, the protein that promotes abnormal blood vessel growth and leakage in the retina. By binding VEGF-A, the antibody is designed to suppress the angiogenic signaling that drives wet age-related macular degeneration. It is an antibody-based therapy given by intravitreal injection.
Tarcocimab tedromer is being developed by Kodiak Sciences Inc, a biopharmaceutical company that trades on the Nasdaq under the ticker KOD. Kodiak Sciences is running the Phase 3 DAYBREAK study of the drug in wet age-related macular degeneration.
Tarcocimab tedromer is in Phase 3 clinical development. It is investigational and has not been approved by the FDA. The Phase 3 DAYBREAK trial is listed as active but no longer recruiting participants, and no completed trials of the drug are recorded.
Tarcocimab tedromer is being evaluated in the Phase 3 DAYBREAK trial, registered as NCT06556368. The study compares tarcocimab tedromer and tabirafusp tedromer with aflibercept in participants with neovascular, or wet, age-related macular degeneration. It is randomized, double-blind, and active-controlled, with an enrollment of 675 participants across the United States and Puerto Rico.