On October 6, 2025, REGENXBIO Inc. announced that enrollment in its two pivotal wet age‑related macular degeneration (wet AMD) studies, ATMOSPHERE and ASCENT, has been completed. The trials evaluate surabgene lomparvovec (sura‑vec, ABBV‑RGX‑314) delivered subretinally and are conducted in partnership with AbbVie.
The ATMOSPHERE study, conducted in the United States, and the ASCENT study, conducted in the United States and 13 other countries, together enrolled more than 1,200 participants across more than 200 sites. Completion of enrollment positions the company to move forward with regulatory submissions and to begin the next phase of data collection and analysis for its first‑time, one‑time gene‑therapy treatment for wet AMD.
This milestone marks a significant step toward the potential approval of ABBV‑RGX‑314 and underscores REGENXBIO’s progress in translating its NAV Technology Platform into a commercial product. The company’s ability to complete enrollment in a large, global pivotal program demonstrates operational capability and strengthens its pipeline momentum for the upcoming regulatory review cycle.
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