REYON Pharmaceutical announced meaningful clinical results for NG101, a gene therapy for wet age-related macular degeneration (wAMD) that it is co-developing with partner Elligene. While existing wAMD patients have had to receive eye injections about 10 times a year on average, patients given NG101 maintained their vision with a once-a-year dose.
REYON Pharmaceutical said on the 7th that Elligene (formerly Neuracle Genetics) presented 52-week results for the low-dose cohort (cohort 1) in a phase 1/2a trial of NG101 at ARVO 2026, the world's largest ophthalmology conference, held in Denver, the United States, from the 3rd to the 7th. The ARVO program committee selected Elligene's presentation as a "Hot Topic." It was recognized as a major study of high academic and clinical importance.
According to the released data, participants in the low-dose cohort (cohort 1) had received anti-VEGF injections an average of 9.8 times per year before joining the trial, but during the 52-week follow-up after NG101 administration, the average number of injections fell sharply to 1.1.
Results were also confirmed in patient-by-patient responses. Of the six total participants, five (83%) maintained their vision with no more than one additional injection over 52 weeks. Notably, three of the six needed no additional injections at all for the entire year.
Key measures such as visual acuity (BCVA) and central subfield thickness (CST) were stably maintained, and no serious adverse events (SAE) or dose-limiting toxicities (DLT) were observed.
NG101 has now completed dosing in 20 participants. REYON Pharmaceutical plans to secure an interim report for the phase 1/2a trial in the third quarter of this year. After that, it intends to begin full-fledged discussions on technology out-licensing along with entry into a global phase 2b trial.
A REYON Pharmaceutical official said, "The therapeutic effect of NG101 has been proven," and added, "We will concentrate top-tier GMP manufacturing capabilities to ensure the successful commercialization of NG101."
REYON Pharmaceutical holds the exclusive global manufacturing and supply rights for NG101 under a co-development agreement signed with Elligene in 2020. In particular, REYON Pharmaceutical plans to use its smart factory in Chungju as a key hub responsible for NG101's global commercial supply.
According to industry sources, the global wAMD therapeutics market is expected to grow at a compound annual rate of 12.1%, from about $6.7 billion (about 9 trillion won) in 2023 to about $16.6 billion in 2031. In particular, the AAV-based wAMD gene therapy market, such as NG101, is expected to grow at an average annual rate of 60% through 2030.