• Demonstrated a dramatic reduction of approximately 90% in anti-VEGF administration (injection) frequency compared to global competitors across all dose cohorts.
• Confirmed visual improvement effects correlating with dose increases... Demonstrated an 8-letter improvement in visual acuity in the high-dose group, proving the therapeutic potential of NG101 for vision improvement.
• Plans to obtain U.S. Phase 2b clinical trial approval in the first half of 2027.
Reyon Pharmaceutical announced on the 13th that its partner and investee company Elisigen, in which Reyon is the largest shareholder, presented 24-week results from the high-dose cohort (Cohort 3) of the Phase 1/2a clinical trial of NG101, a gene therapy for wet age-related macular degeneration (wet AMD), at the American Academy of Ophthalmology (AAO), the world’s largest ophthalmology conference.
The American Academy of Ophthalmology (AAO) is the world's largest professional ophthalmology academic conference, where ophthalmologists, pharmaceutical and biotech companies, and investors gather to discuss the latest clinical trial results, new drug development trends, and treatment guidelines. AAO 2026 was held from October 9 to 12 in New Orleans, Louisiana, USA.
At the congress, the clinical results of NG101 were presented by Dr. Robert A. Sisk, a retina specialist at the Cincinnati Eye Institute and Professor of Ophthalmology at the University of Cincinnati. Dr. Sisk possesses extensive clinical and research experience in the fields of retinal diseases and gene therapy, having participated in various inherited retinal disease and gene therapy clinical trials. In particular, he is participating as the Principal Investigator (PI) and surgeon in Elisigen’s NG101 Phase 1/2a clinical trial and is scheduled to serve as the U.S. National PI for Elisigen’s NG101 Phase 2b clinical trial.
This clinical trial was conducted on a total of 20 patients with wet age-related macular degeneration, designed with a low-dose group (6 patients), intermediate-dose group (6 patients), and high-dose group (8 patients) depending on the dosage administered. Following the presentation of 52-week results for the low-dose group at ARVO in May and 52-week results for the low-dose group and 44-week results for the intermediate-dose group at ASRS in July, Elisigen presented long-term 52-week observation data for the low- and intermediate-dose groups and 24-week data for the high-dose group at this congress.
According to the presentation, NG101 demonstrated consistent therapeutic efficacy across all dose cohorts by dramatically reducing anti-VEGF injection frequency by over 90% post-administration. The intermediate-dose group showed an 89% reduction in injection frequency at 52 weeks compared to baseline, while the high-dose group also demonstrated superior efficacy, requiring an average of only 0.5 injections per patient over the 24 weeks post-administration.
In particular, due to the degenerative nature of wet age-related macular degeneration, simply maintaining vision without loss is typically evaluated as a successful treatment outcome. Not only did NG101 achieve the primary goal of vision maintenance in the low- and intermediate-dose groups, but the high-dose group also demonstrated a groundbreaking therapeutic effect with an 8-letter improvement in visual acuity.
An 8-letter improvement means that patients were able to read 8 more letters than before on the standard visual acuity chart (ETDRS chart), representing an approximately 20–30% improvement compared to baseline vision. In the field of ophthalmology clinical trials, a meaningful visual improvement effect is generally considered to begin at 5 letters or more; this high-dose group data clearly showcases the definite vision-improving efficacy of NG101.
Unlike conventional standard treatments where patients must endure ongoing and burdensome intraocular injections approximately 10 times a year for life, NG101 aims to provide long-lasting therapeutic effects lasting once a year or less—or for several years—with just a single administration, while also proving outstanding visual improvement outcomes. Consequently, it has garnered high clinical value recognition from related academic societies and business partners.
Regarding safety, excellent tolerability was confirmed across all patient groups regardless of dosage increases, with no drug-related serious adverse events (SAEs) or dose-limiting toxicities (DLTs) reported.
With the acquisition of consistent efficacy and safety data across all dose cohorts in the Phase 1/2a clinical trial, Elisigen recently completed a Type-B meeting with the U.S. Food and Drug Administration (FDA) to advance into Phase 2b clinical trials. Based on this, the company plans to secure Phase 2b approval within the first half of 2027. NG101 was previously designated as a Fast Track development product by the FDA.
NG101 is an adeno-associated virus (AAV) vector-based gene therapy. Loaded with the aflibercept gene—the active ingredient of the blockbuster treatment "Eylea," which has global annual sales of approximately KRW 13 trillion—it is designed to allow retinal cells to autonomously express anti-VEGF protein for a prolonged period following a single subretinal administration.
Jong-Mook Kim, CEO of Elisigen, stated, "This was an opportunity to widely publicize to the global ophthalmology community and business partners the clinical potential of NG101—developed by our company—to drastically reduce the burden of anti-VEGF injections through a consistent single administration from low- to high-dose groups. We are currently preparing to gain U.S. Phase 2b clinical trial approval early next year."
Meanwhile, Reyon Pharmaceutical, as the largest shareholder of Elisigen, is in charge of the co-research, development, and global production and supply of NG101. Upon entering the commercialization stage, Reyon plans to exclusively supply NG101 to the global market through the state-of-the-art GMP facility at its Chungju plant.
