Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as KSI-501
Tabirafusp tedromer · 1 trial · 1 indication
Mean change in BCVA from Day 1 to Year 1
| Arm | Type | Description |
|---|---|---|
| Tabirafusp tedromer 5 mg Q8W | EXPERIMENTAL | Intravitreal injection of tabirafusp tedromer once every 4 weeks for 6 monthly doses followed by every-8-week dosing with additional individualized dosing (up to monthly dosing) |
| Tabirafusp tedromer 5 mg Q4-24W | EXPERIMENTAL | Intravitreal injection of tabirafusp tedromer once every 4 weeks for 6 monthly doses followed by individualized dosing every 4 to 24 weeks. |
| Aflibercept 2 mg | ACTIVE_COMPARATOR | Intravitreal injection of aflibercept once every 4 weeks for 5 monthly doses followed by every-8-week dosing |
| Name | Type | Description |
|---|---|---|
| Tabirafusp tedromer | DRUG | Intravitreal injection |
| Aflibercept (2.0 mg) | DRUG | Intravitreal injection |
Inclusion Criteria: * DME, treatment-naïve or previously-treated * Male or female ≥18 years of age with Type 1 or Type 2 diabetes mellitus and a HbA1c of ≤12% * Capable of giving informed signed consent Exclusion Criteria: * Active iris or angle neovascularization or neovascular glaucoma in the S...
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 |
Tabirafusp tedromer is an investigational small molecule being developed for the treatment of Diabetic Macular Edema (DME), a condition affecting the retina in people with diabetes. It is currently in Phase 3 clinical development and has not been approved by regulatory authorities.
Tabirafusp tedromer targets IL-6 and VEGF, two proteins involved in inflammation and blood vessel growth that contribute to Diabetic Macular Edema. By inhibiting these targets, the drug aims to address the underlying disease processes in the eye.
Tabirafusp tedromer is being developed by Kodiak Sciences Inc (NASDAQ: KOD), a biopharmaceutical company focused on treatments for retinal diseases. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with Diabetic Macular Edema.
Tabirafusp tedromer is in Phase 3 clinical development. It is an investigational drug, meaning it has not yet received regulatory approval and is still being studied in clinical trials to determine its safety and effectiveness for treating Diabetic Macular Edema.
Tabirafusp tedromer is being studied in a Phase 3 clinical trial with the identifier NCT07734844, known as the ALTO study. This randomized, double-blind, active-controlled trial is comparing Tabirafusp tedromer to aflibercept in approximately 910 participants with Diabetic Macular Edema in the United States.