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# Tenpoint Therapeutics’ Positive Data on Vision Drug
- URL: https://www.fdaweb.com/tenpoint-therapeutics-positive-data-on-vision-drug/
- Published: 2025-01-10T12:00:00.000Z
- Updated: 2026-09-14T14:50:40.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158468

Tenpoint Therapeutics is reporting positive topline results from BRIO-II, the company’s second Phase 3 pivotal trial evaluating Brimochol PF (brimonidine), a pupil-modulating therapeutic designed to correct the loss of near vision associated with presbyopia. BRIO-II met its pre-specified primary endpoints, demonstrating statistically significant improvements in near vision versus vehicle at all time points out to eight hours, according to the company.

Brimochol PF also demonstrated clinically and statistically significant reductions in pupil size, Tenpoint says, adding that reducing pupil size is the “key mechanism of action for the miotic class of therapies creating a pinhole effect that corrects for the loss of near vision and increases depth of focus. Brimochol PF accomplishes this while improving distance vision and providing a gradual resolution of miosis over 10 hours. Less miosis later in the day may minimize difficulties with night-time vision.”

Regarding safety, Brimochol PF was well-tolerated over a 12-month daily dosing period with no treatment-related serious adverse events, the company says.