Tenpoint Therapeutics Announces Breakthrough Phase 3 Results for Presbyopia Treatment Following Merger with Visus

Positive Phase 3 Data:
Tenpoint Therapeutics has announced positive topline data from its Phase 3 pivotal study, BRIO-II, for BRIMOCHOL PF, a treatment for presbyopia35.

Merger Background:
The announcement comes after Tenpoint Therapeutics completed its merger with Visus Therapeutics, combining their ophthalmic therapeutic portfolios to focus on aging-related ocular conditions4.

Clinical Outcomes:
BRIMOCHOL PF demonstrated statistically significant improvements in near vision and reading speed, with clinically and statistically significant reductions in pupil size at all timepoints, enhancing depth of focus and correcting for the loss of near vision35.

Safety and Tolerability:
The drug was well-tolerated over a 12-month daily dosing period with no treatment-related serious adverse events, and it showed no tachyphylaxis in vision or pupil effects35.

Regulatory Pathway:
The positive results pave the way for a New Drug Application (NDA) submission in the first half of 2025, with plans for commercialization in the US by 20264.

Combination Therapy:
BRIMOCHOL PF combines carbachol and brimonidine, offering enhanced efficacy and duration while reducing ocular redness, making it a promising treatment for presbyopia4.

Sources:

3. 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

4. https://www.modernretina.com/view/tenpoint-therapeutics-and-visus-therapeutics-complete-merger-combining-ophthalmic-therapeutics-portfolios

5. https://eyewire.news/news/tenpoint-therapeutics-announces-positive-topline-data-from-phase-3-pivotal-study-of-brimochol-pf-for-the-treatment-of-presbyopia