South Korea's MFDS receives NDA for Tenpoint Therapeutics' Brimochol PF for presbyopia

Tenpoint Therapeutics partner Zhaoke Ophthalmology is supporting its South Korean partner, Kwangdon Pharmaceutical, in its submission of a new drug application (NDA) for Brimochol™ preservative free (PF) to the Ministry of Food and Drug Safety (MFDS) in South Korea for the correction of presbyopia.¹ The submission marks the first ex-US regulatory submission for Brimochol PF, according to a news release.

Kwangdon would be responsible for the manufacturing and distribution of the novel pupil-modulating eye drop in South Korea.¹

“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, CEO of Tenpoint Therapeutics, in the release. “We appreciate the collaboration with Zhaoke Ophthalmology and [Kwangdon Pharmaceutical, or] 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.”

The NDA submission in the country was supported by positive data from Tenpoint’s first pivotal phase 3 BRIO-I study for the drop, “which demonstrated the benefit of the combination therapy over the individual monotherapy active drug components – a requirement for approval of a fixed-dose combination,” according to the release. Additionally, the second vehicle-controlled phase 3 BRIO-II study demonstrated that patients experience a 3-lines or greater improvement in binocular uncorrected near visual acuity (BUCNVA), without the loss of 1line or more in binocular uncorrected distance visual acuity (BUCDVA). Thus, Brimochol achieve all primary near vision improvement endpoints in the second study. The drop was also well-tolerated with no serious treatment-related adverse events through the entire BRIO-II study, spanning over 70,000 treatment days.¹

“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 Li Xiaoyi (Benjamin), PhD, chairman of the Board of Executive Director and CEO of Zhaoke Ophthalmology, in the release. “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.”

Earlier this year

The news out of South Korea follows the NDA that was accepted by the US FDA back in June 2025, which was submitted by Tenpoint in April the same year. The PDUFA date that was set by the FDA is slated for January 28, 2026.²

In December 2024, Tenpoint and Visus Therapeutics merged. Prior to this merger, Brimochol PF was being investigated by Visus.²

References

1. Tenpoint Therapeutics Ltd. announces submission of a new drug application for Brimochol PF for the treatment of presbyopia to the MFDS in South Korea. News release. Businesswire. November 5, 2025. Accessed November 5, 2025. https://www.businesswire.com/news/home/20251105608942/en/Tenpoint-Therapeutics-Ltd.-Announces-Submission-of-a-New-Drug-Application-for-BRIMOCHOL-PF-for-the-Treatment-of-Presbyopia-to-the-MFDS-in-South-Korea
2. Maharjan EK. FDA accepts NDA for Tenpoint Therapeutics’ Bromochol PF for presbyopia. Optometry Times. June 3, 2025. Accessed November 5, 2025. https://www.optometrytimes.com/view/fda-accepts-nda-for-tenpoint-therapeutic-s-brimochol-pf-for-presbyopia