Tenpoint Therapeutics Reports Positive Phase 3 Results for BRIMOCHOL™ PF in Presbyopia Treatment

Tenpoint Therapeutics, Inc., a leading clinical-stage biotech firm, has announced promising results from its BRIO-II trial. As the company’s second Phase 3 pivotal study, BRIO-II evaluated BRIMOCHOL™ PF, a pioneering therapeutic aimed at rejuvenating vision in individuals with presbyopia. Presbyopia is a common age-related condition that affects near vision, impacting a significant portion of the global population.

The trial successfully met its primary endpoints as defined in collaboration with major regulatory bodies, including the U.S. FDA, the European Medicines Agency (EMA), and the UK Medicines and Healthcare products Regulatory Agency (MHRA). The results showed statistically significant improvements in near vision compared to the control solution at various timepoints up to eight hours (p<0.008). Additionally, BRIMOCHOL™ PF demonstrated considerable reductions in pupil size over time, leveraging the miotic class mechanism to enhance depth of focus and correct near vision loss. The solution not only improved near vision but also positively impacted distance vision, with a gradual resolution of miosis observed over a ten-hour period, which reduces night-time vision difficulties.

During the 12-month at-home dosing phase, BRIMOCHOL™ PF was well-tolerated, exhibiting no serious adverse effects related to the treatment. No diminishing response, known as tachyphylaxis, was detected in terms of vision enhancement or pupil response throughout the study. Participants also reported improved reading speeds and enhanced quality of life, as assessed by the NEI-Refractive Error Quality of Life questionnaire. Further insights into these findings will be shared at future scientific events.

Dr. Rhett Schiffman, Tenpoint’s Chief Medical Officer and Head of Research and Development, emphasized the significance of BRIMOCHOL™ PF in the presbyopia treatment category. He noted that the combination of brimonidine with carbachol in BRIMOCHOL™ PF not only extended the therapeutic effect but also minimized hyperemia compared to carbachol alone. Dr. Schiffman highlighted the comprehensive 12-month safety analysis of BRIMOCHOL™ PF and praised the high compliance and willingness of study participants to use the drug, acknowledging the concerted efforts of the trial’s investigators and subjects.

The BRIO-II trial was a multicenter, randomized, double-masked study, evaluating the safety and efficacy of BRIMOCHOL™ PF against carbachol monotherapy and a placebo control in subjects with emmetropic phakic or pseudophakic presbyopia. The study involved 629 participants across 47 sites in the United States.

Dr. John Hovanesian, a member of Tenpoint’s Medical Advisory Board, expressed satisfaction with the trial’s outcomes, particularly the functional improvement in reading speed achieved by BRIMOCHOL™ PF. He expressed optimism about the potential approval of the product, which could address the needs of a large portion of individuals suffering from presbyopia.

Tenpoint Therapeutics is at the forefront of developing innovative treatments for vision impairments associated with aging, including presbyopia, cataracts, and geographic atrophy. BRIMOCHOL™ PF, its leading asset, is aimed at correcting near vision loss in presbyopia, which affects approximately two billion people worldwide. Following the completion of two pivotal Phase 3 trials, the company plans to submit a New Drug Application in the United States by the first half of 2025, with a market launch anticipated in 2026. Tenpoint’s leadership comprises experienced professionals with a history of successful drug approvals and commercialization, supported by renowned investors in the biotech sector.