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ABBV-RGX-314 · 1 trial · 9 indications
BCVA measured by Early Treatment Diabetic Retinopathy Study (ETDRS)
Incidence of ocular AEs and any SAEs
| Arm | Type | Description |
|---|---|---|
| ABBV-RGX-314 Dose 1 | EXPERIMENTAL | ABBV-RGX-314 Dose 1 administered via subretinal delivery one time. |
| ABBV-RGX-314 Dose 2 | EXPERIMENTAL | ABBV-RGX-314 Dose 2 administered via subretinal delivery one time. |
| Control Arm | ACTIVE_COMPARATOR | Ranibizumab administered via intravitreal injection approximately every 28 days |
| Name | Type | Description |
|---|---|---|
| ABBV-RGX-314 | GENETIC | AAV8 vector containing a transgene for anti-VEGF Fab (Dose 1) |
| Ranibizumab (LUCENTIS®) | BIOLOGICAL | 0.5 mg (0.05 mL of 10 mg/mL solution) administered by intravitreal injection approximately every 28 days |
Inclusion Criteria: 1. Age ≥ 50 years and ≤ 89 years 2. An ETDRS BCVA letter score between ≤ 78 and ≥ 40 in the study eye 3. Diagnosis of subfoveal CNV secondary to AMD in the study eye previously treated with anti-VEGF 4. Must be pseudophakic (at least 12 weeks postcataract surgery) in the study e...
ABBV-RGX-314 is an investigational gene therapy being developed for the treatment of age-related macular degeneration (AMD), specifically neovascular or wet AMD. It is administered via subretinal delivery as a one-time treatment. The drug is currently in Phase 2 clinical development and is not yet approved by regulatory authorities.
ABBV-RGX-314 is a gene therapy designed to deliver a gene that encodes for an anti-angiogenic protein, which targets vascular endothelial growth factor (VEGF) to inhibit the abnormal blood vessel growth and leakage that characterize wet AMD. This mechanism aims to provide a durable, one-time treatment for the condition.
ABBV-RGX-314 is being developed by AbbVie Inc., a biopharmaceutical company listed on the New York Stock Exchange under the ticker symbol ABBV. The drug is currently in Phase 2 clinical trials for the treatment of neovascular age-related macular degeneration.
ABBV-RGX-314 is currently in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA or any other regulatory agency. The drug is being studied in an active, not recruiting, Phase 2 trial for the treatment of wet age-related macular degeneration.
ABBV-RGX-314 is being evaluated in a Phase 2 clinical trial with the identifier NCT04704921, titled 'Pivotal 1 Study of ABBV-RGX-314 Gene Therapy Administered Via Subretinal Delivery One Time in Participants With nAMD.' This active, not recruiting trial has an enrollment of 671 participants and is being conducted in the United States.
Yes, ABBV-RGX-314 is also known as RGX-314. The drug is referred to by both names in clinical trial documentation, with the Phase 2 study NCT04704921 explicitly noting that ABBV-RGX-314 is also known as RGX-314.