In a phase 3 trial, Tenpoint Therapeutics’ eye drop—a combination of carbachol and brimonidine—improved vision for patients with presbyopia for up to eight hours.
The top-line results come from BRIO-II, Tenpoint’s second phase 3 pivotal trial for Brimochol PF, a topical eye treatment the biotech plans to submit for FDA approval in the first half of this year, according to a Jan. 9 release.
The eye drop is designed to correct presbyopia, or age-related farsightedness. The late-stage trial enrolled 629 participants with both emmetropic phakic or pseudophakic presbyopia and included three arms: patients who received one daily drop of Brimochol PF per eye, those who received carbachol (sold as Miostat for glaucoma) or those who received a control solution.
Brimochol PF is a fixed-dose combination of carbachol and brimonidine, the latter of which is sold as Mirvaso or Alphagan P for glaucoma.
Patients who received the investigational eye drop demonstrated statistically significant improvements in near vision compared to the control solutions at all time points out to eight hours, meeting the study’s primary endpoint, the biotech said.
No treatment-related serious adverse events were tied to Brimochol PF, with Tenpoint finding the drug to be well tolerated over a 12-month period. In additional analyses, the eye drop treatment was tied to significantly improved reading speed and patient-reported quality of life outcomes, according to the company.
Tenpoint expects to share more data from the trial at an upcoming medical conference.
London-based Tenpoint picked up the drug from its recent merger with Seattle-based Visus Therapeutics, which closed last month. Visus had already studied the eye drop in an initial phase 3 pivotal trial, The combined biotech is prepping for a potential U.S. commercial launch for the eye drop in the first half of 2026.