Tenpoint Therapeutics announced positive topline results from its Phase 3 BRIO-II trial, evaluating BRIMOCHOL™ PF for the treatment of presbyopia. The trial met its primary endpoints, showing statistically significant improvements in near vision compared to the vehicle at all time points up to 8 hours (p<0.008). These results pave the way for a potential US regulatory filing in the first half of 2025. The study enrolled 629 subjects across 47 sites in the United States.
The positive outcomes from the BRIO-II trial highlight a potential new treatment option for the estimated two billion people globally affected by presbyopia. Current treatments, such as reading glasses or surgery, can be inconvenient or invasive. BRIMOCHOL™ PF offers a potentially less invasive alternative for managing age-related near vision loss.
Key Findings from the BRIO-II Trial
The BRIO-II trial was a three-arm, double-masked study comparing BRIMOCHOL™ PF to carbachol monotherapy and a vehicle. The study demonstrated not only visual acuity improvement but also increased reading speed and improved patient-reported outcomes. The mechanism of action involves reducing pupil size, creating a pinhole effect that enhances near vision focus.
- Efficacy: BRIMOCHOL™ PF demonstrated statistically significant improvements in near vision versus vehicle at all timepoints out to 8 hours (p<0.008).
- Safety: The eye drop was well-tolerated through 12 months of daily dosing, with no treatment-related serious adverse events.
- Mechanism: Clinically and statistically significant reductions in pupil size were observed at all time points.
- Additional Benefits: The brimonidine component appears to enhance carbachol’s effects while mitigating potential side effects like eye redness.
Brimonidine's Role
According to Rhett Schiffman, M.D., M.S., M.H.S.A., 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." He noted that brimonidine increased the magnitude and duration of action of carbachol and reduced the incidence of hyperemia (eye redness) over carbachol alone.
Potential Market Impact
If approved, BRIMOCHOL™ PF could become a widely adopted first-line therapy, offering a convenient and effective way to manage age-related vision decline. This could also establish Tenpoint Therapeutics as a leader in the ophthalmic therapeutics market.
John Hovanesian, M.D., a member of Tenpoint’s Medical Advisory Board, stated, "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."
