AbbVie and Regenxbio Announce Updates on the ABBV-RGX-314 Clinical Program in DR and Wet AMD

AbbVie and Regenxbio announced updates to the ABBV-RGX-314 gene therapy clinical program.

Data from the ATMOSPHERE and ASCENT pivotal trials evaluating the safety and efficacy of the subretinal delivery of ABBV-RGX-314 in patients with wet AMD are expected in 2026. The companies also plan a phase 3 clinical program utilizing the in-office SCS Microinjector to deliver gene therapy to the suprachoroidal space of the eye.

ABBV-RGX-314 is being investigated as a potential one-time treatment for wet AMD, diabetic retinopathy (DR) and potentially other chronic retinal conditions. ABBV-RGX-314 consists of the NAV AAV8 vector, which encodes an antibody fragment designed to inhibit vascular endothelial growth factor (VEGF). ABBV-RGX-314 is believed to inhibit the VEGF pathway by which new, leaky blood vessels grow and contribute to the accumulation of fluid in the retina.[1]

AbbVie and Regenxbio are advancing the development of two separate routes of administration of ABBV-RGX-314 to the eye, through a standardized subretinal delivery procedure as well as delivery to the suprachoroidal space. Regenxbio licensed certain exclusive rights to the SCS Microinjector from Clearside Biomedical to deliver gene therapy treatments to the suprachoroidal space of the eye.