Tenpoint Therapeutics announces positive topline results from Phase 3 pivotal trial BRIO-II assessing BRIMOCHOL PF for the treatment of presbyopia

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Clinical stage biotech company Tenpoint Therapeutics announced positive topline results from BIO-II, a Phase 3 pivotal trial assessing BRIMOCHOL PF for the treatment of presbyopia. According to a company news release, the clinical trial successfully met pre-specified visual acuity primary endpoints in both the US and European Union (EU)/United Kingdom (UK) with statistically significant near vision improvements recorded at all time points over 8 hours (p<0.008). Those primary endpoints were agreed upon with the US FDA, European Medicines Agency, and the UK Medicines and Healthcare Products Regulatory Agency.¹

The 3-arm, multicenter, randomized, double masked, safety and efficacy study (NCT05135286) evaluated BRIMOCHOL PF, a carbachol/brimonidine tartrate fixed-dose combination topical ophthalmic solution, in comparison to a carbachol monotherapy topical ophthalmic solution and a vehicle topical ophthalmic solution in the 629 participants with emmetropic phakic or pseudophakic presbyopia. Participants were enrolled in 47 different sites in the US.¹

“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 at Tenpoint, in the release. “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 eye drop 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.”

Tenpoint cited that brimonidine also significantly improved reading speed and patient reported quality of life outcomes based on the NEI-Refractive Error Quality of Life questionnaire, in addition to no treatment related serious adverse events reported. Additionally, BRIMOCHOL PF demonstrated clinically and statistically significant reductions in pupil size at all timepoints. This reduction in pupil size was cited as a key mechanism of action for the miotic class of therapies creating a pinhole effect that correct for the loss of near vision and increases depth of focus.¹

While BRIMOCHOL PF accomplished correction of lost near vision and a depth of focus increase, distance vision improvements and gradual resolution of miosis over 10 hours was also recorded in the clinical trial. According to Tenpoint, less miosis later in the day may minimize difficulties concerning nighttime vision. Additionally, no tachyphylaxis was observed in either vision or pupil effects over the duration of the 12 month at-home dosing phase of the study.¹

“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 Tenpoint’s Medical Advisory Board, in the release. “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.”

Further details from the study will be presented at upcoming scientific meetings, according to Tenpoint.¹

Reference:

1. Tenpoint Therapeutics announces positive topline data from Phase 3 pivotal study, BIO-II, of BRIMOCHOL PF for the treatment of presbyopia. News release. Tenpoint Therapeutics. January 8, 2025. Accessed January 9, 2025.