AbbVie and REGENXBIO Announce Updates on ABBV-RGX-314 Gene Therapy Programs

AbbVie and REGENXBIO have provided updates on their ABBV-RGX-314 gene therapy clinical programs targeting retinal diseases. Regarding wet AMD, two Phase III trials, ATMOSPHERE® and ASCENT™, are currently being initiated and exploring the efficacy and safety of subfoveal administration of ABBV-RGX-314, the results of which are expected in 2026. Furthermore, a Phase III clinical program in DR is envisaged with the in-office SCS Microinjector® for the administration of the therapy to the suprachoroidal space—a less invasive approach.

Such activities should be designed to meet major therapeutic needs for progressive retinal diseases. ‘Wet’ AMD and DR are examples of retinal diseases that need better treatment regimens that are less invasive and require less patient compliance,’ said Michael Robinson, M.D. of AbbVie. Curran Simpson, REGENXBIO’s CEO, also nodded his approval in acknowledging the global possibilities for the ABBV-RGX-314, which is a one-time gene therapy; this was in a way that marked the major breakthrough in the battle against blindness that is caused by such heinous disorders.