Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Tarcocimab, Tarcocimab tedromer
KSI-301 · 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 ...
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 |
KSI-301 is an investigational small molecule developed by Kodiak Sciences Inc for retinal diseases. It is being studied as an intravitreal therapy for macular edema and wet age-related macular degeneration. It remains in clinical development and has not been approved by the FDA.
KSI-301 is being evaluated for the treatment of macular edema, including macular edema due to retinal vein occlusion, and for neovascular (wet) age-related macular degeneration. Both are retinal conditions involving abnormal blood vessel growth and fluid leakage in the eye.
KSI-301 targets VEGF, or vascular endothelial growth factor, a protein that drives abnormal blood vessel growth and vascular leakage in the retina. By binding VEGF, the drug is designed to reduce the vessel growth and fluid accumulation that characterize macular edema and wet age-related macular degeneration.
KSI-301 is being developed by Kodiak Sciences Inc, which trades on the Nasdaq under the ticker KOD. The company is the sponsor of the clinical program evaluating the drug in retinal disease.
KSI-301 is in Phase 3 clinical development. It is investigational and has not been approved by the FDA. The Phase 3 program includes completed trials in wet age-related macular degeneration and in macular edema due to retinal vein occlusion.
KSI-301 has been studied in two completed Phase 3 trials. NCT04964089 evaluated intravitreal KSI-301 versus intravitreal aflibercept in wet age-related macular degeneration, enrolling 557 participants. NCT04592419 compared KSI-301 with aflibercept in macular edema due to retinal vein occlusion, enrolling 568 participants.