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RO7303359 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Single Ascending Dose Stage | EXPERIMENTAL | Participants will receive a single dose of RO7303359, in multiple escalating cohorts (A-D). |
| Expansion Cohort Stage | EXPERIMENTAL | Participants will receive the maximum tolerated dose (MTD) or the maximum tested dose (MTeD) as determined in the single ascending dose stage. |
| Optional Cohort E | EXPERIMENTAL | An optional additional cohort may be added with the dose not exceed the MTD or MTeD. |
| Optional cohort F | EXPERIMENTAL | An optional additional cohort may be added with the dose not exceed the MTD or MTeD. |
| Name | Type | Description |
|---|---|---|
| RO7303359 | DRUG | RO730359 will be administered as a single intravitreal injection. |
Ocular Inclusion Criteria Study Eye: * Visual acuity: BCVA letter score of 19-48 ETDRS letters (Snellen equivalent of 20/125-20/400) using ETDRS charts at a starting distance of 4 meters * Well-demarcated area of GA secondary to AMD in the absence of choroidal neovascularization (CNV) * GA area mus...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Regeneron Pharmaceuticals, Inc. | REGN | 2 | PHASE3 | Pozelimab, Cemdisiran |
| Annexon, Inc. | ANNX | 1 | PHASE3 | Vonaprument |
| Belite Bio, Inc. ADR | BLTE | 1 | PHASE3 | Tinlarebant |
| Johnson & Johnson | JNJ | 1 | PHASE2 | JNJ-81201887 |
| AbbVie, Inc. | ABBV | 1 | PHASE1 | ABBV-6628, SYFOVRE |
| Sanofi SA Sponsored ADR | SNY | 1 | PHASE1 | SAR446597, Sham Comparator |
| Ocugen Inc | OCGN | 1 | PHASE1 | OCU410 |
| Apellis Pharmaceuticals, Inc. | APLS | 1 | - | Pegcetacoplan |
RO7303359 is an investigational small molecule being developed for geographic atrophy, a form of age-related macular degeneration. It is administered as an intravitreal injection. The drug is currently in Phase 1 clinical development and is not yet approved for any use.
RO7303359 is being developed by Roche Holding AG, which trades under the ticker RHHBY. The company is conducting clinical trials to evaluate the safety, tolerability, pharmacokinetics, and immunogenicity of the drug in patients with geographic atrophy.
RO7303359 is in Phase 1 clinical development. A Phase 1 study has been completed, evaluating the drug in participants with geographic atrophy secondary to age-related macular degeneration. The drug remains investigational and has not received regulatory approval.
RO7303359 has one completed clinical trial, identified as NCT04615325. This Phase 1 study evaluated the safety, tolerability, pharmacokinetics, and immunogenicity of intravitreal injections of RO7303359 in participants with geographic atrophy. The trial enrolled 37 participants in the United States.
RO7303359 is administered as an intravitreal injection, meaning it is injected directly into the vitreous humor of the eye. This route of administration is commonly used for ophthalmic therapies targeting conditions like geographic atrophy.