Tenpoint Therapeutics Reports Positive Phase 3 Data for Brimochol PF in Presbyopia Treatment

Tenpoint Therapeutics has announced positive topline results from BRIO-II, its second Phase 3 pivotal trial evaluating Brimochol PF for the treatment of presbyopia. The trial met its prespecified primary endpoints, demonstrating statistically significant improvements in near vision versus the vehicle across all timepoints up to 8 hours (P<0.008).

Key Findings: Brimochol PF Efficacy and Safety

Enhanced Vision and Depth of Focus

       • Brimochol PF showed clinically and statistically significant reductions in pupil size at all timepoints.

       • The pinhole effect, created by the reduction in pupil size, compensates for the loss of near vision and enhances depth of focus.

       • The treatment improved distance vision while offering a gradual resolution of miosis over 10 hours, minimizing potential night-time vision difficulties.

Long-Term Benefits

       • No tachyphylaxis (diminished response over time) was observed in vision or pupil effects throughout the 12-month at-home dosing phase.

       • Brimochol PF significantly improved:

              - Reading speed.

               - Patient-reported quality of life outcomes, measured by the NEI-Refractive Error Quality of Life questionnaire.

Safety and Tolerability

       • Brimochol PF was well-tolerated over a 12-month daily dosing period.

       • No treatment-related serious adverse events were reported.

       • High compliance and willingness to use the drug were noted among study participants.

Scientific and Clinical Impact

According to Rhett Schiffman, MD, MS, MHSA, Chief Medical Officer and Head of Research and Development at Tenpoint Therapeutics:

“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.”

Schiffman highlighted that brimonidine:

       • Increases the magnitude and duration of carbachol’s action.

       • Reduces the incidence of hyperemia (eye redness) compared to carbachol alone.

Brimochol PF is the first presbyopia-correcting eye drop to complete a 12-month safety study, marking a significant milestone in the presbyopia treatment landscape.

About the BRIO-II Study

The BRIO-II trial was a 3-arm, multicenter, randomized, double-masked study designed to evaluate the safety and efficacy of Brimochol PF (carbachol/brimonidine tartrate fixed-dose combination) compared to:

       • Carbachol monotherapy topical ophthalmic solution.

       • Vehicle topical ophthalmic solution.

The trial enrolled 629 subjects with emmetropic phakic or pseudophakic presbyopia across 47 sites in the United States (NCT05135286).

Looking Ahead

Brimochol PF represents a significant advancement in presbyopia treatment by offering patients improved vision, safety, and convenience. Further insights and detailed findings will be presented at upcoming scientific meetings, continuing to solidify Brimochol PF's role in transforming the presbyopia treatment paradigm.