Tenpoint Therapeutics announced the submission of a New Drug Application (NDA) for its investigational presbyopia treatment Brimochol PF to the Ministry of Food and Drug Safety (MFDS) in South Korea, marking the first regulatory submission outside the United States for the therapy. Brimochol PF is a preservative-free combination eye drop designed to improve near vision in patients with presbyopia.

The submission was led by Kwangdong Pharmaceutical Co. (KDP), Tenpoint’s South Korean commercialization partner, with support from Zhaoke Ophthalmology, an ophthalmic pharmaceutical company in Asia. KDP will oversee manufacturing and distribution of Brimochol PF in South Korea.

The South Korean filing was supported by positive results from two pivotal phase 3 trials. BRIO-I demonstrated superior efficacy of the combination therapy over its individual components—a requirement for fixed-dose combination approval. BRIO-II, a vehicle-controlled study in which Brimochol PF met all primary endpoints, achieving statistically significant 3-line or greater improvements in binocular uncorrected near visual acuity without compromising distance visual acuity.

“We believe Brimochol PF has the potential to become a best-in-class treatment for people with presbyopia,” said Henric Bjarke, CEO of Tenpoint Therapeutics. “The NDA filing in South Korea is an important step in making this therapy available to patients globally.”

Dr. Li Xiaoyi (Benjamin), CEO of Zhaoke Ophthalmology, added, “This milestone marks a critical first step in our broader Asia-Pacific strategy. Our partnerships position us to effectively bring Brimochol PF to the millions of presbyopia patients across the region.”

In addition to the South Korean submission, an NDA for Brimochol PF is under review by the US FDA, with a Prescription Drug User Fee Act target date of January 28, 2026.