Product Description
ABBV-RGX-314 is our product candidate for the treatment of wet age-related macular degeneration (AMD). ABBV-RGX-314 is being developed as a novel, one-time treatment for wet AMD that includes the NAV® AAV8 vector containing a gene encoding for a monoclonal anti-VEGF antibody fragment. (Sourced from: https://www.regenxbio.com/therapeutic-programs/)
Mechanisms of Action: Gene Therapy,VEGF
Novel Mechanism: Yes
Modality: Gene Therapy
Route of Administration: N/A
FDA Designation: None *
Approval Status: Not Approved
Approved Countries: None
Approved Indications: None
Known Adverse Events: None
Company: AbbVie
Company Location: NORTH CHICAGO IL 60064
Company CEO: Richard A. Gonzalez
Additonal Commercial Interests: Regenxbio
Clinical Description
Countries in Clinic: Canada, France, Germany, Hungary, Italy, Japan, Puerto Rico, Spain, United Kingdom, United States
Active Clinical Trial Count: 7
Highest Development Phases
Phase 3: Neovascular age-related macular degeneration|Wet Macular Degeneration
Phase 2: Choroid Diseases|Diabetic Retinopathy|Macular Edema
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
---|---|---|---|---|---|
RGX-314 SRLTFU | P2 |
Enrolling by invitation |
Neovascular age-related macular degeneration|Wet Macular Degeneration |
2028-12-01 |
24% |
RGX-314-3101/M23-409 | P3 |
Unknown Status |
Neovascular age-related macular degeneration |
2026-11-30 |
|
ASCENT | P3 |
Recruiting |
Neovascular age-related macular degeneration|Wet Macular Degeneration |
2025-11-01 |
|
AAVIATE | P2 |
Recruiting |
Wet Macular Degeneration|Neovascular age-related macular degeneration |
2025-10-21 |