Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
RO7497372 · 1 trial · 1 indication
Number of participants with severe or serious drug-related IOI AEs severity will be determined according to the DAIDS toxicity grading scale as reported by the Investigator.
| Arm | Type | Description |
|---|---|---|
| Part 1: Multiple Ascending Dose | EXPERIMENTAL | Participants will receive multiple ascending doses of RO7497372, 3 times every 4 weeks (Q4W) as an IVT injection up to Week 8 in the study eye. |
| Part 2: RO7497372 Low Dose | EXPERIMENTAL | Participants will receive 6 doses of RO7497372, low dose, Q4W followed by 3 doses, every eight weeks (Q8W) as an IVT injection up to Week 44 in the study eye. |
| Part 2: RO7497372 High Dose | EXPERIMENTAL | Participants will receive 6 doses of RO7497372, high dose, Q4W followed by 3 doses, Q8W as an IVT injection up to Week 44 in the study eye. Treatment in this arm has been discontinued due to the Sponsor's decision. |
| Name | Type | Description |
|---|---|---|
| RO7497372 | DRUG | RO7497372 will be administered as IVT injection as per the schedule specified in the arms. |
Inclusion Criteria: * Diagnosis of diabetes mellitus (type 1 or type 2), as defined by the world health organization (WHO) and/or American Diabetes Association * Participant consents to AH collection * Collection of \> 90 microlitres (µL) AH (at each visit required per schedule of activities \[SoA\...
| 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 |
RO7497372 is an investigational small molecule being developed for the treatment of diabetic macular edema (DME), a condition that causes vision loss due to fluid accumulation in the macula of the eye. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.
RO7497372 is being developed by Roche Holding AG, a multinational healthcare company. Roche's stock is traded under the ticker symbol RHHBY on the OTC market. The drug is currently in Phase 1 clinical trials for diabetic macular edema.
RO7497372 is in Phase 1 clinical development. It is an investigational drug being studied for the treatment of diabetic macular edema. The drug has not been approved by the FDA or any other regulatory agency and is still undergoing clinical trials to evaluate its safety and efficacy.
RO7497372 is being studied in a Phase 1 clinical trial with the identifier NCT06847854. This trial is investigating the safety, tolerability, pharmacokinetics, and pharmacodynamics of RO7497372 in participants with diabetic macular edema. The study is active but not recruiting and has an enrollment of 151 participants.
RO7497372 is a small molecule being developed for diabetic macular edema. The specific molecular target of RO7497372 has not been disclosed in the available information, so its exact mechanism of action is not publicly known. It is currently in Phase 1 clinical trials to evaluate its safety and efficacy.