Data from pivotal trials evaluating a one-time gene therapy for patients with neovascular age-related macular degeneration (nAMD) is expected in 2026.
ABBV-RGX-314 is being investigated as a potential treatment for nAMD, diabetic retinopathy (DR), and potentially other chronic retinal conditions. It uses the NAV AAV8 vector to deliver an antibody fragment designed to inhibit vascular endothelial growth factor (VEGF). By targeting the VEGF pathway, this therapy aims to prevent the growth of leaky blood vessels and reduce fluid accumulation in the retina, addressing key factors in nAMD and DR.
In a news update, AbbVie and REGENXBIO said the pivotal ATMOSPHERE and ASCENT trials evaluating the safety and efficacy of subretinal delivery of ABBV-RGX-314 in patients with nAMD anticipate releasing results in 2026.
As well, AbbVie and REGENXBIO will plan the Phase 3 clinical program of investigational ABBV-RGX-314 in DR. The clinical program will use the in-office SCS Microinjector to deliver gene therapy to the suprachoroidal space of the eye.
We are excited to continue moving closer to our goal of delivering an additional treatment option to patients with wet AMD and DR…
“Retinal diseases are progressive, with wet AMD and DR among the leading causes of blindness,” said Dr Michael Robinson, vice president, global head of ophthalmology clinical development, AbbVie.
“More treatment options are needed to help relieve the current treatment burden of chronic, frequent dosing. We are excited to continue moving closer to our goal of delivering an additional treatment option to patients with wet AMD and DR in hopes of addressing their significant unmet needs.”
Reference
- AbbVie, AbbVie and REGENXBIO announce updates on the ABBV-RGX-314 clinical program, (news release, 13 Jan 2025), available at: news.abbvie.com/2025-01-13-AbbVie-and-REGENXBIO-Announce-Updates-on-the-ABBV-RGX-314-Clinical-Program [accessed Jan 2025].
