Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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...
| 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 |
Tabirafusp tedromer is an investigational small molecule being developed for the treatment of Diabetic Macular Edema (DME). It is currently in Phase 3 clinical development and has not been approved by regulatory authorities. The drug is being studied in patients with DME to evaluate its efficacy and safety.
Tabirafusp tedromer is being developed by Kodiak Sciences Inc, a biopharmaceutical company traded on the NASDAQ under the ticker symbol KOD. The company is conducting a Phase 3 clinical trial to evaluate the drug's efficacy and safety in patients with Diabetic Macular Edema.
Tabirafusp tedromer is currently in Phase 3 clinical development. It is an investigational drug and has not yet received FDA approval. The ongoing Phase 3 trial is actively recruiting participants to study the drug's efficacy and safety compared to aflibercept in patients with Diabetic Macular Edema.
Tabirafusp tedromer is being studied in a Phase 3 clinical trial with the identifier NCT07734844, titled 'A Study to Evaluate the Efficacy and Safety of Tabirafusp Tedromer Compared to Aflibercept in Participants With DME - ALTO'. This randomized, double-blind, active-controlled trial is recruiting 910 participants in the United States.
Tabirafusp tedromer is not FDA approved. It is an investigational drug currently in Phase 3 clinical development for Diabetic Macular Edema. The drug is being evaluated in an active-controlled trial against aflibercept, but it has not yet completed clinical testing or received regulatory approval.