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ABBV-RGX-314 Dose 1 · 2 trials · 8 indications
To evaluate the noninferiority of ABBV-RGX-314 relative to aflibercept in mean change from Baseline BCVA at Week 54
AEs and SAEs through Week 50
To evaluate the effect of ABBV-RGX-314 on DR by the ETDRS DRSS at Week 48.
To evaluate the effect of ABBV-RGX-314 on BCVA at Week 54.
| 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 | Aflibercept administered via intravitreal injection approximately every 8 weeks |
| Part 1: Observation Control Arm | NO_INTERVENTION | Observation Control |
| Part 1: ABBV-RGX-314 Treatment Arm (Dose 1) | EXPERIMENTAL | ABBV-RGX-314 Dose 1 |
| Part 1: ABBV-RGX-314 Treatment Arm (Dose 2) | EXPERIMENTAL | ABBV-RGX-314 Dose 2 |
| Part 1: ABBV-RGX-314 Treatment Arm (Dose 3) and Topical Steroid | EXPERIMENTAL | ABBV-RGX-314 Dose 3 and Topical Steroid |
| Part 2: ABBV-RGX-314 Treatment Arm (Dose 4) and Topical Steroid | EXPERIMENTAL | ABBV-RGX-314 Dose 4 and Topical Steroid |
| Part 2: Aflibercept Control | ACTIVE_COMPARATOR | Control treatment arm |
| Name | Type | Description |
|---|---|---|
| ABBV-RGX-314 Dose 1 | GENETIC | AAV8 vector containing a transgene for anti-VEGF Fab (Dose 1) |
| ABBV-RGX-314 Dose 2 | GENETIC | AAV8 vector containing a transgene for anti-VEGF Fab (Dose 2) |
| Aflibercept (EYLEA®) | BIOLOGICAL | 2.0 mg (0.05 mLsolution) administered by intravitreal injection approximately every 8 weeks after 3 monthly injections |
| ABBV-RGX-314 Dose 3 | GENETIC | AAV8 vector containing a transgene for anti-VEGF fab (Dose 3) |
| Topical Steroid | DRUG | Topical Steroid |
| ABBV-RGX-314 Dose 4 | GENETIC | AAV8 vector containing a transgene for anti-VEGF fab (Dose 4) |
| Aflibercept | BIOLOGICAL | Aflibercept |
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 choroidal neovascularization (CNV) secondary to AMD in the study eye previously treated with anti-VEGF 4. Must be pseudophakic (at least 12 weeks postc...
ABBV-RGX-314 Dose 1 is an investigational gene therapy being developed for the treatment of age-related macular degeneration (AMD) and diabetic retinopathy (DR). It is administered in the suprachoroidal space and is currently in Phase 3 clinical development for these ophthalmologic conditions.
ABBV-RGX-314 Dose 1 is a gene therapy designed to deliver a gene that encodes for a therapeutic protein. While the specific molecular target is not disclosed, the therapy is intended to provide a durable treatment effect for retinal diseases by enabling the eye to produce the therapeutic agent locally.
ABBV-RGX-314 Dose 1 is being developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol ABBV. The therapy is part of AbbVie's ophthalmology pipeline and is currently in Phase 3 clinical trials.
ABBV-RGX-314 Dose 1 is in Phase 3 clinical development. It is an investigational gene therapy and has not been approved by regulatory authorities. The therapy is being evaluated in active clinical trials for diabetic retinopathy and neovascular age-related macular degeneration.
ABBV-RGX-314 Dose 1 is being studied in two active clinical trials. NCT05407636 is a Phase 3 pivotal study in participants with neovascular AMD, enrolling 735 participants across multiple countries. NCT04567550 is a Phase 2 study in diabetic retinopathy with and without center-involved diabetic macular edema, enrolling 139 participants in the United States.
ABBV-RGX-314 Dose 1 is a specific dose of the gene therapy RGX-314. The trials listed under ABBV-RGX-314 Dose 1 evaluate RGX-314 administered in the suprachoroidal space, and the drug is referred to by both names in clinical research.