FDA Accepts NDA for Brimochol PF to Treat Presbyopia

The U.S. Food and Drug Administration (FDA) has officially accepted the New Drug Application (NDA) for Brimochol PF, a novel presbyopia treatment developed by Tenpoint Therapeutics. The Prescription Drug User Fee Act (PDUFA) target action date has been set for January 28, 2026.

Brimochol PF: Investigational Combination Therapy for Presbyopia

If approved, Brimochol PF would become the first fixed-dose combination therapy for presbyopia. The formulation combines brimonidine and carbachol to induce a pinhole effect—improving depth of focus and enhancing both near and distant vision. According to Tenpoint, the combination achieves greater peak efficacy and longer duration than either monotherapy alone.

“This milestone marks a significant step forward in our transition toward becoming a commercial-stage company,” said Henric Bjarke, CEO of Tenpoint Therapeutics.
“As the only combination product of its kind, Brimochol PF offers the potential for a best-in-class product. With our commercial leadership team now in place, we are fully engaged in launch preparations and anticipate product availability in 1H 2026.”

Strong Clinical Support from Phase 3 Trials

The NDA submission was supported by results from two pivotal phase 3 studies:

BRIO-I Study

       • Demonstrated the superior efficacy of the combination therapy compared to individual components, satisfying the FDA’s requirements for fixed-dose combination products.

BRIO-II Study (Vehicle-Controlled)

       • Achieved all primary and secondary endpoints.

       • Showed statistically significant 3-line or greater improvements in binocular uncorrected near visual acuity (BUNVA) over 8 hours.

       • Maintained stable binocular uncorrected distance visual acuity (BUDVA) with no loss of 1 line or more.

       • Over 70,000 treatment days were monitored with no serious treatment-related adverse events observed.

Regulatory Outlook

The FDA has indicated it does not plan to convene an advisory committee meeting to discuss the NDA. Tenpoint submitted the application in April 2025, and pending FDA approval, Brimochol PF is expected to launch in the first half of 2026.