AbbVie and REGENXBIO have announced updates to the ABBV-RGX-314 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.

AbbVie and REGENXBIO will plan a Phase 3 clinical program. The clinical program will utilize the in-office SCS Microinjector® to deliver gene therapy to the suprachoroidal space of the eye.

"Retinal diseases are progressive, with wet AMD and DR among the leading causes of blindness. 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," said Michael Robinson, MD, Vice President, Global Head of Ophthalmology Clinical Development, AbbVie.

"ABBV-RGX-314 has the potential to help millions of people living with wet AMD and DR, globally, who are facing these debilitating diseases. Together with AbbVie, we are excited to continue developing ABBV-RGX-314 as the first potential one-time gene therapy for wet AMD and DR," said Curran Simpson, president and chief executive officer, REGENXBIO.