Elisigen Presents Positive Phase 1/2a Data for NG101 in wet AMD Across All Dose Cohorts at AAO
SEOUL, South Korea, October 13, 2026 — Elisigen, a clinical-stage biotechnology company developing AAV gene therapies for ophthalmology and neurology, announced clinical results from all three dose cohorts of its Phase 1/2a trial evaluating NG101 for wet age-related macular degeneration (wet AMD). The data were presented at the American Academy of Ophthalmology (AAO) 2026 Annual Meeting in New Orleans, Louisiana.
The Phase 1/2a study evaluates three ascending dose levels: low dose (Cohort 1), medium dose (Cohort 2), and high dose (Cohort 3). At AAO, Elisigen presented 52-week data from the low- and medium-dose cohorts together with 24-week data from the high-dose cohort. Across all cohorts, NG101 demonstrated a substantial reduction in supplemental anti-VEGF treatment burden at vector doses at the lower end of the range typically used for subretinal AAV gene therapies.
The medium-dose cohort showed an 89% reduction in supplemental anti-VEGF injections over 52 weeks compared with the annualized injection frequency prior to treatment. Similarly, patients in the high-dose cohort required an average of only 0.5 supplemental anti-VEGF injections during the first 24 weeks following NG101 administration. Early findings from the high-dose cohort also suggested a trend toward greater improvements in visual acuity and retinal anatomical outcomes with increasing dose.
NG101 remained generally well tolerated across all dose cohorts. No drug-related serious adverse events (SAEs) or dose-limiting toxicities (DLTs) were reported. Based on the favorable efficacy and safety profile observed to date, Elisigen plans to advance development toward a Phase 2b study in the United States, with regulatory submission activities currently underway.
About NG101
NG101 is an investigational subretinal AAV gene therapy for wet AMD. It is designed to provide sustained anti-VEGF expression under Elisigen's proprietary CAT311 promoter, with the goal of durable disease control from a single administration at a substantially low vector dose. A Phase 1/2a open-label study is ongoing in the United States and Canada. The U.S. Food and Drug Administration has granted Fast Track designation for NG101 for the treatment of wet AMD.
About Elisigen
Elisigen is a clinical-stage biotechnology company developing AAV gene therapies for ophthalmology and neurology. Proprietary platforms include the CAT311 promoter for high-efficiency transgene expression and the Helper-In-One (dual-plasmid) system for high-yield AAV vector production. The company is headquartered in Seoul, Korea.
Contacts:
IR@elisigen.com