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Label indication VABYSMO is a vascular endothelial growth factor (VEGF) and angiopoietin 2 (Ang-2) inhibitor indicated for the treatment of patients with: VABYSMO is a vascular endothelial growth factor (VEGF) and angiopoietin-2 (Ang-2) inhibitor indicated for the treatment of patients with: Neovascular (Wet) Age-Related Macular Degeneration (nAMD) ( 1.1 ) Diabetic Macular Edema (DME) ( 1.2 ) Macular Edema Following Retinal Vein… FDA label
Also known as VABYSMO™, RO6867461, RG7716
Faricimab PFS Configuration · 2 trials · 3 indications
Thirteen healthcare providers (HCP; seven retina specialists and six assistants) across three sites participated in the study, and they worked mostly in pairs to administer a single intravitreal (IVT) injection of 6-mg faricimab to each of the 35 patients using the prefilled syringe (PFS). For each IVT injection, two Human Factors (HF) observers were positioned such that they could clearly observe the entire preparation and administration process. Each HCP team (i.e., retina specialist alone or retina specialist with assistant, as per local procedure) were asked to perform all preparation and administration steps in view of the HF observers. Critical tasks were observed by the HF observers who documented HCP performance using an assessment checklist. A successful task completion for each critical task was defined as normal use without use error, and the percentages of successful completions are calculated out of the total 35 PFS IVT injections administered.
Thirteen healthcare providers (HCP) across 3 sites participated in the study, and they worked mostly in pairs to administer a single intravitreal (IVT) injection of 6-mg faricimab to each of the 35 patients using the prefilled syringe (PFS). For each IVT injection, two Human Factors (HF) observers were positioned such that they could clearly observe the entire preparation and administration process. Each HCP team (i.e., retina specialist alone or retina specialist with assistant, as per local procedure) were asked to perform all preparation and administration steps in view of the HF observers. Critical tasks were observed by the HF observers who documented HCP performance using an assessment checklist. A use error was defined as user action or lack of user action while using the medical device that leads to a different result than that intended by the manufacturer or expected by the user. The percentages of use errors are calculated out of the total 35 PFS IVT injections administered.
| Arm | Type | Description |
|---|---|---|
| Faricimab PFS Configuration | EXPERIMENTAL | - |
| Part A: RO6867461 | EXPERIMENTAL | Single doses |
| Part B: RO6867461 | EXPERIMENTAL | Multiple doses |
| Name | Type | Description |
|---|---|---|
| Faricimab PFS Configuration | COMBINATION_PRODUCT | Participants will receive a single intravitreal (IVT) injection of the 6-milligram (mg) faricimab dose formulation delivered via prefilled syringe (PFS) with a co-packaged injection filter needle. |
| RO6867461 | DRUG | Single or multiple ascending dose by intravitreal injection |
Inclusion Criteria: * Willing and able to comply with clinic visits and study-related procedures * For female patients of childbearing potential: agree to remain abstinent (refrain from heterosexual intercourse) or use contraception, and agree to refrain from donating eggs, as defined in the protoc...
Faricimab PFS Configuration is a prefilled syringe presentation of faricimab, a monoclonal antibody developed by Roche Holding AG for retinal diseases. It is being studied in neovascular age-related macular degeneration and diabetic macular edema. The prefilled syringe format is designed to deliver the drug in a ready-to-use presentation for intravitreal administration.
Faricimab PFS Configuration is being studied for the treatment of neovascular age-related macular degeneration, a form of wet AMD. It is also being evaluated in diabetic macular edema. The Phase 3 study of this prefilled syringe presentation enrolled patients with either neovascular AMD or diabetic macular edema.
Faricimab PFS Configuration targets two proteins: ANGPT2 (angiopoietin-2) and VEGFA (vascular endothelial growth factor A). It is an inhibitor of both targets. Dual inhibition of these pathways is the mechanism under investigation for retinal vascular conditions such as neovascular age-related macular degeneration.
Faricimab PFS Configuration is developed by Roche Holding AG, which trades under the ticker RHHBY. Roche is the sponsor of the clinical program evaluating this prefilled syringe presentation of faricimab in retinal disease.
Faricimab PFS Configuration is in Phase 3 clinical development. It is investigational and has not been approved by the FDA for the studied indications. The Phase 3 trial evaluating the prefilled syringe has been completed.
Faricimab PFS Configuration was evaluated in the Phase 3 trial NCT05569148, titled A Study in Patients With Neovascular Age-Related Macular Degeneration or Diabetic Macular Edema to Evaluate the Safety of the Faricimab Prefilled Syringe. The trial enrolled 35 patients in the United States and has been completed. It was an uncontrolled study without randomization or blinding.