Company Profile

The proprietary technology and microRNA therapy originated from the two founders’ research team in the medical schools. With generous financial support and administrative assistance from the Taiwan Ministry of Science and Technology, the research team not only demonstrated the potential of microRNA therapy in treating pediatric myopia, but also obtained the safety data and completed the pharmacology and pharmacokinetic studies.

With the assistance from the Taiwan Startup Institute, the research team established Sunhawk Vision Biotech, Inc., a drug development company, in August 2019. The Company takes over the job from the academic research institutes to continue the translation of early R&D results to the clinical trials. Furthermore, the research team continues to identify more new indications for the established microRNA therapy, which includes dry eye disease, corneal erosion etc.

In January 2021, Sunhawk filed the IND to the US FDA for the first-in-human Phase-I trial to test the safety of the proprietary microRNA therapeutic eye drops. The IND application received early approval from the US FDA in February 2021. The first-in-human Phase-I clinical trial (NCT04928144) was completed in 2021 Q3, and the results showed no drug-related adverse event, high tolerability by the pediatric study subjects. A Phase-II trial (NCT05486728) for dry eye disease was completed in 2024 Q2, which further demonstrated great therapeutic effect on improving both symptoms and signs of dry eye disease. There are ongoing trials for myopia control and other corneal diseases.

It is expected that the investigative microRNA therapy will successfully go through different stage of clinical trials and enter the global market in next few years.