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RO7823653 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Part 1: Multiple Ascending Dose (MAD) Monotherapy | EXPERIMENTAL | Participants will receive multiple doses of RO7823653, administered as an IVT injection. |
| Part 2: Optional Multiple-Dose Expansion | EXPERIMENTAL | Participants will receive multiple doses of RO7823653 administered as an IVT injection, at or below the maximum tolerated dose (MTD) or maximum tested dose (MTeD), as determined during the MAD stage. |
| Part 3: MAD (RO7823653 + Faricimab) | EXPERIMENTAL | Participants will receive multiple doses of RO7823653 along with faricimab, administered as an IVT injection. |
| Name | Type | Description |
|---|---|---|
| RO7823653 | DRUG | Participants will receive RO7823653 as an IVT injection per the schedule described in the protocol. |
| Faricimab | DRUG | Participants will receive faricimab as an IVT injection per the schedule described in the protocol. |
Inclusion Criteria: * Diagnosis of diabetes mellitus (type 1 or type 2), as defined by the World Health Organization (WHO) and/or American Diabetes Association * Glycated hemoglobin (HbA1c) \<= 12% * For study eye: Macular thickening secondary to DME involving the center of the fovea with central 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 |
RO7823653 is an investigational small molecule being developed for diabetic macular edema (DME), a complication of diabetes that causes fluid buildup in the macula and can lead to vision loss. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.
The specific molecular target of RO7823653 has not been disclosed. It is a small molecule being studied for its safety, tolerability, pharmacodynamics, and pharmacokinetics in participants with diabetic macular edema. The mechanism of action is not publicly detailed at this time.
RO7823653 is being developed by Roche Holding AG, a multinational healthcare company. Roche is conducting a Phase 1 clinical trial to evaluate the drug in patients with diabetic macular edema. The company's stock is traded under the ticker RHHBY.
RO7823653 is in Phase 1 clinical development. A Phase 1 trial is currently recruiting participants to evaluate the drug's safety, tolerability, pharmacodynamics, and pharmacokinetics in individuals with diabetic macular edema. The drug is investigational and has not been approved for any use.
RO7823653 is being studied in a single Phase 1 clinical trial with the identifier NCT07425522. This trial is recruiting 93 participants with diabetic macular edema in the United States. The study is controlled but not randomized or double-blinded, and it is currently active and recruiting.
No alternative names for RO7823653 have been disclosed. The drug is identified solely by its development code RO7823653. It is a distinct investigational compound being studied by Roche for diabetic macular edema, and no other names or aliases are currently associated with it.