Tenpoint Submits New Drug Application to the FDA for Brimochol PF in Presbyopia

Image Credit: Adobe Stock Images/VISUALPOINT

Tenpoint Therapeutics announced the submission of a New Drug Application (NDA) to the FDA for Brimochol PF (carbachol/brimonidine tartrate), a novel fixed-dose combination eye drop therapy for presbyopia. The treatment combines brimonidine and carbachol to create a pupil-modulating “pinhole effect,” which enhances depth of focus and visual acuity. The NDA is supported by data from the pivotal Phase III BRIO-I and BRIO-II studies, which demonstrated the combination’s superiority over monotherapies and significant improvements in near vision lasting over eight hours.¹

“The submission of the US NDA for Brimochol PF marks a significant milestone for our company,” said Henric Bjarke, CEO, Tenpoint Therapeutics, in a press release. “As we accelerate the build-out of our commercial team in preparation for the anticipated launch in the first half of 2026, we are incredibly proud of the dedication and tireless work that has brought the company to this point. We look forward to collaborating closely with the FDA throughout the NDA review process.”

The multicenter, randomized, double-masked BRIO-I study evaluated safety and efficacy of Brimochol PF in 182 patients with emmetropic phakic or pseudophakic presbyopia in the United States. Subjects received Brimochol PF, carbachol monotherapy, or brimonidine tartrate monotherapy. Brimochol PF achieved the study’s primary endpoint of binocular near visual acuity across multiple time points. Patients gained more than 15 letters on the ETDRS chart without clinically meaningful loss of distance vision, with effects sustained through six hours post-dose.²

The larger three-arm, randomized, double-masked design BRIO-II trial enrolled 629 patients across 47 sites in the United States to compare Brimochol PF to carbachol monotherapy and vehicle. The study met its primary endpoint of improving near vision over an eight-hour period post-dose. Additionally, Brimochol PF demonstrated a gradual resolution of miosis over 10 hours—potentially minimizing nighttime vision issues—and significantly reduced pupil size, the mechanism underlying its therapeutic effect. Brimochol PF was well-tolerated over a 12-month at-home dosing phase, with no treatment-related serious adverse events.^1,3

According to Tenpoint, presbyopia affects approximately two billion people globally and around 128 million people in the United States.1 For adults in the United States who are 45 years of age and older, the prevalence of presbyopia is between 83% and 88.9%. Globally, around 826 million people with presbyopia have near visual impairment due to a lack of or inadequate near vision correction. Additionally, 94% of the population in developing, low-resource countries may have under-corrected or uncorrected vision due to limited treatment access.⁴

“The NDA submission includes data from the world’s largest and longest (12 months) efficacy and safety study in presbyopia, with more than 70,000 dosing days of data. Brimochol PF demonstrated a very favorable tolerability profile and no reduction in efficacy over the 12-month study duration,” said Rhett Schiffman MD, MS, MHSA, chief medical officer, head of research and development, Tenpoint, in the press release. “We also observed additional patient benefits beyond near vision improvements such as statistically significant increases in reading speed and significant lower rates of hyperemia (eye redness) compared with carbachol (p=0.001) and importantly, the rate of vitreous detachment was similar to vehicle. The increase in peak effect and duration of Brimochol PF over carbachol alone, along with the decreased incidence of hyperemia and the lower rate of vitreous detachment are all consistent with previously reported mechanisms of action of brimonidine or related compounds.”

References

1. Tenpoint Therapeutics Ltd. Submits New Drug Application to U.S. FDA for BRIMOCHOL™ PF for the Treatment of Presbyopia. Businesswire. April 8, 2025. Accessed April 8, 2025. https://www.businesswire.com/news/home/20250408026931/en/Tenpoint-Therapeutics-Ltd.-Submits-New-Drug-Application-to-U.S.-FDA-for-BRIMOCHOL-PF-for-the-Treatment-of-Presbyopia

2. Visus Therapeutics presents topline clinical data from Phase 3 pivotal BRIO-I Trial of BRIMOCHOL PF for treatment of presbyopia. Opthalmology Times. May 4, 2023. Accessed April 8, 2025. https://www.ophthalmologytimes.com/view/visus-therapeutics-presents-topline-clinical-data-from-phase-3-pivotal-brio-i-trial-of-brimochol-pf-for-treatment-of-presbyopia

3. Tenpoint Therapeutics Announces Positive Topline Data from Phase 3 Pivotal Study, BRIO-II, of BRIMOCHOL™ PF for the Treatment of Presbyopia. Businesswire. January 9, 2025. Accessed April 8, 2025. https://www.businesswire.com/news/home/20250109824922/en/Tenpoint-Therapeutics-Announces-Positive-Topline-Data-from-Phase-3-Pivotal-Study-BRIO-II-of-BRIMOCHOL-PF-for-the-Treatment-of-Presbyopia

4. Presbyopia by the Numbers: Who Is Affected by It? Presbyopia Physician. Accessed April 8, 2025. https://www.presbyopiaphysician.com/issues/2022/june/presbyopia-by-the-numbers-who-is-affected-by-it/#:~:text=Accordingly%2C%2026%25%20of%20the%20world's,in%20the%20country%20in%202020.