Tenpoint Therapeutics has announced the submission of a New Drug Application (NDA) for BRIMOCHOL™ PF, its investigational treatment for presbyopia, to South Korea’s Ministry of Food and Drug Safety (MFDS) — marking the company’s first ex-US regulatory filing.
The NDA was submitted by Tenpoint’s regional partner, Zhaoke Ophthalmology Ltd., in collaboration with its South Korean affiliate Kwangdong Pharmaceutical Co., Ltd. (KDP), which will handle manufacturing and distribution in the country. The submission positions BRIMOCHOL™ PF to potentially become the first and only fixed-dose combination eye drop specifically designed to address age-related loss of near vision.
The regulatory submission follows encouraging data from two pivotal Phase III trials — BRIO-I and BRIO-II.
The BRIO-I study demonstrated that the combination therapy provided superior efficacy compared to its individual active components, meeting the regulatory requirement for fixed-dose combinations.
The vehicle-controlled BRIO-II study showed that BRIMOCHOL™ PF achieved statistically significant improvements in binocular uncorrected near visual acuity (BUCNVA) — with three lines or more of improvement and no compromise in distance vision — across more than 70,000 treatment days without serious treatment-related adverse events.
“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.
Dr. Li Xiaoyi (Benjamin), Chairman and CEO of Zhaoke Ophthalmology, called the submission “a critical first step in our broader Asia-Pacific strategy,” emphasizing strong regional partnerships that will help to bring BRIMOCHOL™ PF to millions of presbyopic patients across the region.
An NDA for BRIMOCHOL™ PF is already under review by the FDA, with a Prescription Drug User Fee Act (PDUFA) target date of January 28, 2026.
If approved, BRIMOCHOL™ PF could reshape presbyopia management by offering a non-surgical, pharmacologic solution to one of ophthalmology’s most pervasive visual challenges.
Source: Business Wire
