Tenpoint Therapeutics, Ltd., a global, commercial-ready biotechnology company focused on developing groundbreaking treatments to rejuvenate vision in the aging eye,  announced that its partner, Zhaoke Ophthalmology Ltd. (“Zhaoke Ophthalmology”), a leading ophthalmic pharmaceutical company, has supported its South Korean partner, Kwangdong Pharmaceutical Co., Ltd. (“KDP”), in submitting a New Drug Application (NDA) for BRIMOCHOL™ PF to the Ministry of Food and Drug Safety (MFDS) in South Korea. KDP will be responsible for the manufacturing and distribution of BRIMOCHOL™ PF in South Korea.

The NDA submission in South Korea was supported by positive data from the first pivotal Phase 3 BRIO-I study, which demonstrated the benefit of the combination therapy over the individual monotherapy active drug components – a requirement for approval of a fixed-dose combination. In the second vehicle-controlled Phase 3 BRIO-II study, BRIMOCHOL™ PF achieved all primary near vision improvement endpoints with statistically significant three-lines or greater improvement in binocular uncorrected near visual acuity (BUCNVA), without the loss of one line or more in binocular uncorrected distance visual acuity (BUCDVA). In addition, BRIMOCHOL™ PF was well-tolerated with no serious treatment-related adverse events observed in the over 70,000 treatment days monitored in the BRIO-II study.

“We believe BRIMOCHOL™ PF has the potential to become a best-in-class treatment for people with presbyopia, and the NDA filing in South Korea is an important step in our efforts to make it available to patients around the world,” said Henric Bjarke, Chief Executive Officer of Tenpoint Therapeutics. “We appreciate the collaboration with Zhaoke Ophthalmology and KDP that led to this moment and are confident in their highly experienced teams who will continue to manage the MFDS review process and prepare for commercialization in an effort to bring BRIMOCHOL™ PF to market as quickly as possible in South Korea.”

“Together with Tenpoint Therapeutics and KDP, we are excited about this milestone, which marks a critical first step in our broader Asia-Pacific strategy,” said Dr. Li Xiaoyi (Benjamin), Chairman of the Board, Executive Director and CEO of Zhaoke Ophthalmology. “Our partnerships provide us with a strong distribution and commercialization framework, that we believe will enable us to effectively bring BRIMOCHOL™ PF to the millions of presbyopia patients in South Korea and across the Asia-Pacific region.”

In addition to the NDA in South Korea, an NDA for BRIMOCHOL™ PF is under review in the U.S. and Tenpoint Therapeutics has received a Prescription Drug User Fee Act (PDUFA) date from the U.S. Food and Drug Administration (FDA) of January 28, 2026.