Tenpoint Therapeutics and Zhaoke Ophthalmology Announce NDA Filing for Brimochol PF in South Korea

Tenpoint Therapeutics Ltd, a biotechnology company focused on developing treatments to rejuvenate vision in the aging eye, announced that its partner Zhaoke Ophthalmology Ltd has supported 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.

Kwangdong Pharmaceutical will oversee manufacturing and distribution of the product in the country.

This marks the first ex-US regulatory submission for Brimochol PF, which is designed to be the first and only combination eye drop addressing the loss of near vision associated with presbyopia.

Clinical Data Supporting the NDA

The submission was backed by positive results from two pivotal Phase 3 clinical trials:

• BRIO-I Study: Demonstrated the combination therapy’s superior efficacy compared to individual monotherapy components — a key requirement for approval of a fixed-dose combination.
• BRIO-II Study: Achieved all primary endpoints of near-vision improvement, showing statistically significant three-line or greater improvements in binocular uncorrected near visual acuity (BUCNVA) without compromising distance visual acuity (BUCDVA).

The therapy was well-tolerated, with no serious treatment-related adverse events reported over 70,000 treatment days.

Leadership Commentary

“Brimochol PF has the potential to become a best-in-class treatment for presbyopia,” said Henric Bjarke, CEO of Tenpoint Therapeutics. “The NDA filing in South Korea represents an important milestone toward global patient access.”

Dr. Li Xiaoyi (Benjamin), Chairman and CEO of Zhaoke Ophthalmology, added, “This milestone marks the first step in our broader Asia-Pacific strategy, supported by strong partnerships and commercialization frameworks across the region.”

Next Steps

In addition to the South Korean filing, an NDA for Brimochol PF is also under review by the US FDA, with a Prescription Drug User Fee Act (PDUFA) decision date set for January 28, 2026.

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