Tenpoint Therapeutics Submits NDA for Brimochol PF in South Korea

Tenpoint Therapeutics has announced the submission of a New Drug Application (NDA) for Brimochol PF, a preservative-free eye drop for the treatment of presbyopia, to the Ministry of Food and Drug Safety (MFDS) in South Korea. This marks the first regulatory submission outside the United States for the therapy and an important milestone in Tenpoint’s global commercialization efforts.

First International Filing for Brimochol PF

The regulatory filing was made in collaboration with Kwangdong Pharmaceutical Co. (KDP), Tenpoint’s commercialization partner in South Korea, and with support from Zhaoke Ophthalmology, a leading ophthalmic pharmaceutical company in Asia. KDP will be responsible for manufacturing and distribution of Brimochol PF in the South Korean market.

Brimochol PF is a preservative-free fixed-dose combination eye drop developed to improve near vision in patients with presbyopia, a condition characterized by age-related loss of the eye’s ability to focus on close objects.

Backed by Positive Phase 3 Clinical Data

The NDA submission is supported by data from two pivotal Phase 3 trials:

       • BRIO-I demonstrated superior efficacy of Brimochol PF over its individual components, meeting regulatory requirements for fixed-dose combination therapies.

       • BRIO-II, a vehicle-controlled study, met all primary endpoints, with Brimochol PF achieving statistically significant 3-line or greater gains in binocular uncorrected near visual acuity without compromising distance vision.

These findings highlight the potential of Brimochol PF to offer clinically meaningful vision improvement for patients, without the trade-offs often associated with other pharmacologic treatments.

Strategic Perspectives from Global Leadership

“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 our efforts to make it available to patients around the world.”

Dr. Li Xiaoyi (Benjamin), CEO of Zhaoke Ophthalmology, emphasized the regional impact:
“Our partnerships provide us with a strong distribution and commercialization framework, that we believe will enable us to effectively bring BRIMOCHOLTM PF to the millions of presbyopia patients in South Korea and across the Asia-Pacific region.”

In addition to the South Korean filing, Brimochol PF is currently under review by the U.S. Food and Drug Administration (FDA), with a Prescription Drug User Fee Act (PDUFA) target action date of January 28, 2026.