REYON Pharmaceutical announced meaningful clinical results for NG101, a gene therapy for wet age-related macular degeneration (wAMD) that it is co-developing with its subsidiary Elixigen. While existing wAMD patients had to receive eye injections about 10 times a year on average, patients given NG101 maintained their vision with just one dose a year.
REYON Pharmaceutical said on the 7th that Elixigen (formerly Neuracle Genetics) presented 52-week results for the low-dose cohort (cohort 1) of the 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 Elixigen's presentation as a "Hot Topic." It was effectively recognized as a major study of high academic and clinical importance.
According to the data presented, subjects in the low-dose cohort (cohort 1) had received an average of 9.8 anti-VEGF injections per year before the trial, but during the 52-week follow-up after NG101 administration, the average number of injections dropped sharply to 1.1.
Performance was also confirmed in patient-by-patient responses. Of the six total subjects, five (83%) maintained vision over 52 weeks with no more than one additional injection. Notably, three of the six needed no additional injections at all for the entire year.
Key measures such as best-corrected 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 for 20 subjects. REYON Pharmaceutical plans to obtain the phase 1/2a interim report in the third quarter this year. After that, it plans to move in earnest to discuss out-licensing alongside entering 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 for the successful commercialization of NG101."
REYON Pharmaceutical holds the exclusive global manufacturing and supply rights for NG101 under a co-development agreement signed with Elixigen in 2020. In particular, REYON Pharmaceutical plans to use its smart factory in Chungju as a key hub responsible for global commercial supply of NG101 going forward.
According to the industry, the global wAMD therapy market is expected to grow at an average 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.
Meanwhile, REYON Pharmaceutical's share price is surging in the stock market. The inflow of investment capital appears to have followed the announcement of the clinical results the same day.