- BRIMOCHOL PF, successfully met the pre-specified visual acuity primary endpoints for both the US and EU/UK with highly statistically significant near vision improvements over 8 hours, paving the way for US filing in 1H, 2025
- BRIMOCHOL PF was well-tolerated with no serious treatment-related adverse events in the largest and longest safety study ever conducted in the presbyopia eye drop category
- BRIMOCHOL PF demonstrated a statistically significant improvement in ocular hyperemia over the investigational carbachol arm of the study
Tenpoint Therapeutics, Inc., a global, clinical-stage biotech company developing groundbreaking treatments to rejuvenate vision in the aging eye, today reported positive topline results from BRIO-II, the company’s second phase 3 pivotal trial.
BRIO II met the pre-specified primary endpoints agreed upon with the U.S. FDA, and European Medicines Agency (EMA), and the UK Medicines and Healthcare products Regulatory Agency (MHRA), demonstrating statistically significant improvements in near vision versus vehicle at all timepoints out to 8 hours (p<0.008).
BRIMOCHOL PF also demonstrated clinically and statistically significant reductions in pupil size at all timepoints.
The reduction in pupil size is the key mechanism of action for the miotic class of therapies creating a pinhole effect that corrects for the loss of near vision and increases depth of focus. BRIMOCHOL PF accomplishes this while improving distance vision and providing a gradual resolution of miosis over 10 hours.
Less miosis later in the day may minimize difficulties with night-time vision. No tachyphylaxis was observed in either vision or pupil effects over the duration of the 12-month at-home dosing phase of the study.
BRIMOCHOL PF was well-tolerated over a 12-month daily dosing period with no treatment related serious adverse events. In additional analysis, BRIMOCHOL PF significantly improved reading speed and patient-reported quality of life outcomes based on the NEI-Refractive Error Quality of Life questionnaire. Further details will be presented at upcoming scientific meetings.
“Tenpoint Therapeutics is the only company in the presbyopia category to demonstrate contribution of elements with BRIMOCHOL PF, paving the way for a combination drug approval that offers the additional benefits of brimonidine,” said Rhett Schiffman, MD, MS, MHSA, chief medical officer and Head of Research and Development. “In our studies, brimonidine increased the magnitude and duration of action of carbachol and reduced the incidence of hyperemia (eye redness) over carbachol alone. BRIMOCHOL™ PF is the only presbyopia correcting eyedrop to have gone through a 12-month safety study. It was very well-tolerated over 12 months of continuous dosing and subjects in the study reported very high compliance during the study and a strong willingness to use the drug. We are very grateful to the investigators, their staff, and the study participants for their enormous efforts in this groundbreaking trial.”
BRIO-II is a 3-arm, multicenter, randomized, double-masked, safety and efficacy study of BRIMOCHOLTM PF (carbachol/brimonidine tartrate fixed-dose combination) topical ophthalmic solution vs. carbachol monotherapy topical ophthalmic solution vs. a vehicle topical ophthalmic solution in subjects with emmetropic phakic or pseudophakic presbyopia (NCT05135286). The study enrolled 629 subjects across 47 sites in the United States.
“I am very pleased to see that BRIMOCHOL PF was not only well-tolerated over a 12-month dosing study but also achieved a functional improvement in reading speed, something that patients really care about,” said John Hovanesian, MD, a member of the company’s Medical Advisory Board. “BRIMOCHOL PF has demonstrated a profile that, if approved, will meet the needs for a large proportion of presbyopes and I’m excited for the product to become a reality for patients.”