Tenpoint Therapeutics Prepares for 2026 Market Launch Following Successful Phase 3 Trial of BRIMOCHOL PF for Presbyopia Treatment
Successful Phase 3 Trial:
Tenpoint Therapeutics announced positive topline results from the BRIO-II Phase 3 pivotal trial of BRIMOCHOL PF, a carbachol/brimonidine tartrate fixed-dose combination topical ophthalmic solution for treating presbyopia134.
Efficacy and Safety:
The trial demonstrated statistically significant improvements in near vision versus vehicle at all timepoints out to 8 hours (p<0.008) and was well-tolerated over a 12-month daily dosing period with no treatment-related serious adverse events13.
Key Mechanism of Action:
BRIMOCHOL PF reduces pupil size, creating a pinhole effect that corrects for the loss of near vision and increases depth of focus, while also improving distance vision and providing a gradual resolution of miosis over 10 hours13.
Additional Benefits:
The combination of carbachol and brimonidine in BRIMOCHOL PF increased the magnitude and duration of action of carbachol and reduced the incidence of hyperemia (eye redness) compared to carbachol alone13.
Market Launch:
Tenpoint Therapeutics plans to file the US NDA in the first half of 2025, with a potential market launch in 20261.
Global Impact:
Presbyopia affects approximately 2 billion people globally, and BRIMOCHOL PF, if approved, could meet the needs of a large proportion of presbyopes1.
Sources:
1. https://www.businesswire.com/news/home/20250109824922/en/Tenpoint-Therapeutics-Announces-Positive-Topline-Data-from-Phase-3-Pivotal-Study-BRIO-II-of-BRIMOCHOL%E2%84%A2-PF-for-the-Treatment-of-Presbyopia
3. https://www.ophthalmologytimes.com/view/tenpoint-therapeutics-announces-positive-topline-results-from-phase-3-pivotal-trial-brio-ii-assessing-brimochol-pf-for-the-treatment-of-presbyopia