BRIMOCHOL^™ PF for Presbyopia

Presbyopia—the progressive loss of near visual acuity—affects more than 128 million individuals in the U.S. alone¹ and is one of the leading age-related conditions that impacts patients’ independence and functionality. At Tenpoint Therapeutics, we have developed BRIMOCHOL™ PF, a first-of-its kind, preservative-free, combination ophthalmic solution designed to treat presbyopia.

Scientific Innovation and Mechanism of Action

BRIMOCHOL PF combines carbachol 2.75% and brimonidine tartrate 0.1% in a proprietary, preservative-free formulation. This fixed-dose combination works synergistically to enhance near vision through pharmacologically-induced miosis, mimicking the pinhole effect. Carbachol, a muscarinic agonist, constricts the pupil to improve depth of focus, while brimonidine inhibits dilation, prolonging and stabilizing the miotic response. In preclinical pharmacokinetic studies, we observed a 42% increase in the retention of carbachol within the iris and ciliary body when administered alongside brimonidine.

Importantly, brimonidine’s known attribute of reducing ocular redness (an expected side effect of miotic agents) may position BRIMOCHOL PF uniquely in the category with dual-action benefits.

Clinical Validation: The BRIO Program

Our development program includes two pivotal phase 3 trials—BRIO-I and BRIO-II—the largest and longest studies conducted in presbyopia to date, amassing over 72,000 dosing days.^.2,3 BRIO-I showed that the combination therapy outperformed each monotherapy arm (carbachol and vehicle)⁴—a feat no other presbyopia drop has achieved.

BRIO-II further substantiated the drug’s efficacy and safety over 12 months of chronic, at-home use (Table). No serious adverse events were reported. The most common ocular treatment-related adverse event, eye irritation, was reported in just 14.0% of subjects—lower than that of established dry eye medications. Hyperemia rates were significantly lower compared to carbachol monotherapy, underscoring the added value of brimonidine for tolerability.

Efficacy and the “Just Right” Duration

A single drop of BRIMOCHOL PF offers 8–10 hours of improved near vision, with 85% of subjects achieving 20/40 vision or better within 1 hour, and nearly 50% maintaining this improvement at 10 hours. Crucially, the formulation demonstrated no tachyphylaxis, maintaining efficacy and pupil response throughout a year of daily use.

Patient-reported outcomes were particularly compelling: 72% rated the duration as “just right,” confirming the drug’s suitability for daily routines. This characteristic allows users to benefit during their most demanding hours without compromising night vision safety.

Market Opportunity and Strategic Positioning

Presbyopia represents the largest ophthalmic market, with up to 35 million U.S. patients likely to adopt a prescription eye drop solution.⁵ BRIMOCHOL PF holds exclusivity through 2042 via its patents. With a favorable profile in both efficacy and tolerability, and as the only presbyopia-correcting drop to integrate brimonidine for a potential unique redness-relief attribute, it is well positioned for commercial success. It addresses the practical and emotional pain points of patients who seek a reversible, on-demand alternative to glasses or surgery.

Outlook

Our FDA PDUFA date is set for January 28, 2026, with commercialization activities already well underway. Initial U.S. launch plans will be complemented by strategic global partnerships in Asia and Europe. BRIMOCHOL PF represents not only a scientific milestone in the management of presbyopia, but also a foundation for Tenpoint’s broader mission: to rejuvenate vision in the aging eye.

1. New approaches to presbyopia. American Optometric Association Health Policy Institute. https://www.aoa.org/AOA/Documents/Advocacy/HPI/presbyopia%20brief%20HPI%20Final.pdf. Accessed July 14, 2025.

2. NCT05270863,Phase 3 BRIO-I Clinical Study Results. Data on file, Tenpoint Therapeutics.

3. NCT05135286,Phase 3 BRIO-II Clinical Study Results. Data on file, Tenpoint Therapeutics.

4. El-Harazi S, et al. Safety and efficacy of preservative-free carbachol 2.75%/brimonidine tartrate 0.1% compared to its individual components in presbyopia. Poster presented at: American Society of Cataract and Refractive Surgery (ASCRS); April 5-8, 2024; Boston.

5. Reckner Healthcare market research, December 2024. Data on file with Tenpoint Therapeutics.

For more information: https://www.tenpointtherapeutics.com/

For inquiries, contact Brandi Robinson at brandikrobinson@tenpointtx.com