Elisigen Reports Positive Medium-Dose Results from Phase 1/2a Trial of NG101 for Wet AMD at ASRS
July 20, 2026
SEOUL, South Korea, July 20, 2026 — Elisigen, a clinical-stage biotechnology company developing AAV gene therapies for ophthalmology and neurology, announced 44-week follow-up data from the medium-dose cohort (Cohort 2) of its Phase 1/2a clinical trial evaluating NG101. The investigational subretinal AAV gene therapy is being developed for the treatment of wet age-related macular degeneration (wet AMD). The data were presented by Dr. Peter Kertes, Principal Investigator at Sunnybrook Health Sciences Centre and Professor at the University of Toronto, at the 44th Annual Scientific Meeting of the American Society of Retina Specialists (ASRS).
The Phase 1/2a trial of NG101 evaluates three ascending dose levels: low dose (Cohort 1), medium dose (Cohort 2), and high dose (Cohort 3). Following the presentation of 52-week low-dose (Cohort 1) data this past May, expectations for the newly shared medium-dose data centered on whether the therapy could maintain consistent efficacy and preserve its favorable safety profile following dose escalation. The 44-week findings from the medium-dose cohort successfully addressed these focal points. The data indicate that the medium dose reduced the frequency of supplemental anti-VEGF injections by 90% following administration, compared to the patients' annualized injection rate prior to the NG101 intervention.
Furthermore, the medium-dose group showed a trend toward dose-dependent improvement, noting encouraging gains in visual acuity and key anatomical measures relative to Cohort 1. Importantly, the dose escalation did not compromise patient safety. NG101 remained well-tolerated across the cohort, with investigators reporting no drug-related serious adverse events (SAEs) or dose-limiting toxicities (DLTs).
Based on the favorable safety and efficacy profiles observed to date, Elisigen plans to present 24-week data from the high-dose cohort (Cohort 3) by the end of the year.
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 lower 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