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RO7446603 · 1 trial · 1 indication
BCVA will be measured via Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters using a set of three precision VisionTM or lighthouse distance acuity charts (modified ETDRS Charts 1, 2, and R) prior to dilating eyes by a trained and certified visual acuity (VA) examiner. The range of EDTRS is 0 to 100 letters. Higher scores indicate improvement in VA.
BCVA will be measured via ETDRS chart at a starting distance of 4 meters using a set of three precision VisionTM or lighthouse distance acuity charts (modified ETDRS Charts 1, 2, and R) prior to dilating eyes by a trained and certified VA examiner. The range of EDTRS is 0 to 100 letters. Higher scores indicate improvement in VA.
BCVA will be measured via ETDRS chart at a starting distance of 4 meters using a set of three precision VisionTM or lighthouse distance acuity charts (modified ETDRS Charts 1, 2, and R) prior to dilating eyes by a trained and certified VA examiner. The range of EDTRS is 0 to 100 letters. Higher scores indicate improvement in VA.
| Arm | Type | Description |
|---|---|---|
| Part 1: Single Ascending Dose (SAD) Stage | EXPERIMENTAL | Participants received a single dose of RO7446603 at five different dose levels as IVT injection on Day 1. |
| Part 2: Multiple Dose (MD) Monotherapy Stage | EXPERIMENTAL | Participants received four different dose levels of RO7446603 (two doses at each planned dose level) as IVT injection, every 8 weeks (Q8W). |
| Part 3: MD Co-administration With Aflibercept Stage | EXPERIMENTAL | Participants received two different dose levels (two doses at each planned dose level) of RO7446603 as IVT injection, Q8W along with four doses of aflibercept IVT injections, every 4 weeks (Q4W). |
| Part 4: MD Co-administration With Faricimab Stage | EXPERIMENTAL | Participants received a single dose of faricimab followed by a 4-week enrichment screening period. Eligible participants received two different dose levels (two doses at each planned dose level) of RO7446603 as IVT injection, Q8W, along with three doses of faricimab (co-administered with RO7446603 or alone) as IVT injection, Q4W. |
| Part 5: MD Co-mixed With Faricimab Stage | EXPERIMENTAL | Participants will receive two different dose levels of RO7446603 (co-mixed with faricimab or faricimab alone) as IVT injection, Q4W for the first six doses followed by Q8W for four doses. |
| Name | Type | Description |
|---|---|---|
| RO7446603 | DRUG | Participants will receive RO7446603 as an IVT injection per the schedule described in the treatment arms. |
| Aflibercept | DRUG | Participants will receive aflibercept as an IVT injection per the schedule described in the treatment arm. |
| Faricimab | DRUG | Participants will receive faricimab as an IVT injection per the schedule described in the treatment arms. |
Inclusion Criteria: * Documented diagnosis of diabetes mellitus (DM) (Type 1 or Type 2) with glycated hemoglobin (HbA1c) \< 12% * Macular thickening secondary to DME involving the center of the fovea \> 325 microns * Decreased VA attributable primarily to DME between 25 and 73 ETDRS letters Exclus...
| 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 |
RO7446603 is an investigational small molecule being studied for the treatment of Diabetic Macular Edema, a condition that causes vision loss due to fluid accumulation in the macula. It is administered alone or in combination with aflibercept or faricimab in clinical trials.
The molecular target of RO7446603 has not been disclosed. It is a small molecule modality being evaluated for its safety, tolerability, pharmacokinetics, and efficacy in participants with Diabetic Macular Edema.
RO7446603 is being developed by Roche Holding AG, which trades under the ticker RHHBY. The company is conducting clinical research on this investigational therapy for Diabetic Macular Edema.
RO7446603 is in Phase 1 clinical development. It is an investigational drug, not yet approved by regulatory authorities, and is being studied for safety, tolerability, pharmacokinetics, and efficacy in Diabetic Macular Edema.
RO7446603 is associated with clinical trial NCT06850922, a Phase 1 study evaluating the drug alone or in combination with aflibercept or faricimab in participants with Diabetic Macular Edema. The trial enrolled 388 participants and has been completed.
No, RO7446603 is a distinct investigational small molecule. Aflibercept and faricimab are separate therapies used as combination partners in the clinical trial evaluating RO7446603 for Diabetic Macular Edema.