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KSI-301 · 2 trials · 3 indications
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 |
|---|---|---|
| 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 |
|---|---|---|
| KSI-301 | DRUG | Intravitreal Injection |
| Aflibercept | 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: * Signed informed consent prior to participation in the study. * Treatment-naïve choroidal neovascularization (CNV) secondary to AMD. * BCVA ETDRS score between 83 and 25 letters, inclusive, in the Study Eye. * Decrease in vision in the Study Eye determined by the Investigator t...
| 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 |
KSI-301 is an investigational small molecule being developed for ophthalmology indications, specifically macular edema and wet age-related macular degeneration. It is being studied in patients with macular edema due to retinal vein occlusion and in participants with neovascular (wet) age-related macular degeneration.
KSI-301 is being developed by Kodiak Sciences Inc, a biopharmaceutical company traded on the NASDAQ under the ticker symbol KOD. The company is conducting clinical trials to evaluate the drug's efficacy and safety in ophthalmology indications.
KSI-301 is in Phase 3 clinical development. Two Phase 3 trials have been completed, one in macular edema due to retinal vein occlusion and one in wet age-related macular degeneration. The drug is investigational and has not been approved by regulatory authorities.
KSI-301 has completed two Phase 3 trials. NCT04592419 evaluated KSI-301 compared to aflibercept in 568 patients with macular edema due to retinal vein occlusion. NCT04964089 evaluated KSI-301 compared to aflibercept in 557 participants with wet age-related macular degeneration. Both trials were randomized, double-blind, and active-controlled.
No, KSI-301 is not the same as aflibercept. KSI-301 is an investigational drug developed by Kodiak Sciences, while aflibercept is a separate, approved therapy used as an active comparator in KSI-301's clinical trials. The trials compare KSI-301 directly against aflibercept to evaluate efficacy and safety.