Regenxbio’s ABBV-RGX-314 featured in published study for wet AMD

Regenxbio announced the publication of results from the Phase I/IIa trial evaluating the safety and tolerability of a single dose of subretinal ABBV-RGX-314 for the treatment of wet age-related macular degeneration – wet AMD -. These positive study results informed the ongoing pivotal trials of ABBV-RGX-314, a potential one-time gene therapy, for the treatment of wet AMD. The findings in The Lancet demonstrated that a single administration of ABBV-RGX-314 was generally well tolerated. Stable or improved visual acuity and retinal thickness was observed with few or no supplemental anti-VEGF injections in most patients at two years. Patients who received therapeutic doses demonstrated sustained levels of ABBV-RGX-314 protein and stable or improved vision and retinal anatomy with few, to no, supplemental anti-VEGF injections in most participants up to two years. ABBV-RGX-314 is currently being evaluated in patients with wet AMD in two pivotal trials. Enrollment is on track and these trials are expected to support global regulatory submissions with the FDA and the EMA in late 2025 through the first half of 2026.