Korea’s Ministry of Food and Drug Safety approved Nunaps’ clinical trial of Nunap Vision, a digital therapeutics for improving visual disorders after brain injury. The green light indicates the go-ahead for Korea’s first clinical trial of a digital treatment.
Korea Biomedical Review articulates three generations of therapy: the first-generation therapy was that of the therapeutic compound; the second-generation therapeutic agents (antibody, protein, cell) and the third-generation therapeutic agent—that of digital which includes software programs such as apps, games, virtual reality, chatbots and AI.
Clinical Investigator Sites
The clinical research effort will occur at prominent Korean clinical investigator sites including:
- Asan Medical Center
- Samsung Medical Center
- Seoul National University Bundang Hospital
The sponsor will work with the research sites to test the effectiveness and safety of the Nunap Vision program.
In South Korea the Korea Biomedical Review reports up to 20,000 new patients who suffer form visual disorders post brain injury annually. Often visual impairment is associated with this class of injury—clouding the visual field despite nothing wrong with the optic nerve and eyes. There is no viable treatment for this condition.
Nunaps Capitalizes on Gap in Care
Nunaps CEO Kwang Dong-hwa reports his company is well positioned for success. He noted “The company expects to take a leading position in the global market after completing a large-scale clinical trial.” He continued “The approval of the new clinical trial will become the first step in securing the local market dominance for digital therapy.”Source: Korea Biomed