Reyon Pharmaceutical announced on the 15th that the interim results for the low-dose cohort of the Phase 1/2a clinical trial of 'NG101'—a gene therapy for wet age-related macular degeneration (wet AMD) co-developed with Neuracle Genetics—were successfully presented at the Retina Society 2025 annual meeting. Through this presentation, NG101’s excellent therapeutic efficacy and favorable safety profile were confirmed, which is expected to further enhance its competitiveness in the global market.
The clinical trial (SENSE Study, NCT05984927) was conducted to evaluate the safety, tolerability, and initial efficacy of NG101. According to the disclosed 24-week follow-up results of the low-dose cohort (1 x 109 vg/eye), patients who received a single administration of NG101 demonstrated a remarkable 91% reduction in the frequency of conventional anti-VEGF antibody therapy injections. This signifies a breakthrough that could drastically alleviate the treatment burden on patients, who previously had to receive an average of 9.8 injections per year. Furthermore, Best-Corrected Visual Acuity (BCVA) and Central Retinal Thickness (CST) remained stable up to week 36 post-administration, confirming the durability of the therapeutic effect. In terms of safety, no serious adverse events (SAEs) or dose-limiting toxicities (DLTs) were reported, other than mild or transient adverse events, thereby proving the safety of a single low-dose administration.
NG101 is garnering substantial attention particularly because it demonstrated a distinct therapeutic effect at a dose as low as one-thirtieth of that used by competitor therapies currently under development. A lower dose of adeno-associated virus (AAV) required for treatment enhances safety and reduces production costs, which is anticipated to serve as a powerful competitive advantage during global technology licensing and commercialization processes.
Currently, antibody- and protein-based therapies such as Eylea, Vabysmo, and Lucentis are used as standard of care (SoC) for the treatment of wet AMD. However, these therapies require repeated intravitreal injections, imposing a significant treatment burden on patients. The data from the NG101 Phase 1/2a low-dose cohort showed that a single administration alone can reduce the frequency of treatment injections by more than 90%.
NG101 is being recognized as a next-generation treatment with the potential to fundamentally shift the wet AMD treatment paradigm, moving far beyond merely improving the treatment cycle. Thanks to its mechanism of providing a sustained therapeutic effect by expressing anti-VEGF proteins within retinal cells over the long term, it is expected to overcome the limitations of existing antibody/protein therapies and drastically improve patients' quality of life. Some industry experts forecast that once commercialized, NG101 could position itself as a "game changer" in the market.
An official from Reyon Pharmaceutical stated, "Since the joint development agreement in 2020, we have been efficiently advancing the entire process of clinical trials, manufacturing, and commercialization of NG101 by combining Neuracle Genetics' outstanding development capabilities with Reyon Pharmaceutical's global manufacturing infrastructure. These interim clinical results represent an important milestone that proves the synergy of this collaboration."
According to market reports, the global market for wet AMD treatments, which Neuracle Genetics is targeting, is expected to grow from approximately $6.7 billion (about 9 trillion KRW) in 2023 to approximately $16.6 billion (about 23 trillion KRW) by 2031, at a compound annual growth rate (CAGR) of 12.1%. In particular, the AAV-based wet AMD gene therapy market is cited as a sector anticipated to witness the highest growth, surging from approximately $500 million (about 700 billion KRW) in 2026 to approximately $4.9 billion (about 7 trillion KRW) by 2031, with a CAGR of roughly 59.6%. If NG101 successfully achieves commercialization, it is expected to secure a pivotal position in this high-growth market.
