FDA Accepts Tenpoint's New Drug Application for Brimochol PF for the Treatment of Presbyopia

Tenpoint Therapeutics announced that the FDA has accepted the new drug application (NDA) for Brimochol PF for the treatment of presbyopia. The FDA has set a Prescription Drug User Fee Act (PDUFA) date of January 28, 2026. The FDA noted that it is not planning to hold an advisory committee meeting to discuss this application.

“This milestone marks a significant step forward in our transition toward becoming a commercial-stage company, and we look forward to collaborating closely with the agency throughout the review process,” Henric Bjarke, Chief Executive Officer of Tenpoint Therapeutics, said in a company news release. “As the only combination product of its kind, Brimochol PF offers the potential for a best-in-class product, achievable through a unique and differentiated profile. With our commercial leadership team now in place, we are fully engaged in launch preparations as we anticipate a product availability in 1H 2026.”

Brimochol PF combines brimonidine and carbachol in a pupil-modulating eye drop. This combination produces a “pinhole effect,” intended to improve the depth of focus and sharpen near and distant images, with the benefit of greater peak efficacy and duration relative to monotherapy alone, according to Tenpoint. This formulation would be the first combination therapy for presbyopia if approved by the FDA.

The NDA submission was supported by positive data from the first pivotal phase 3 BRIO-I study, which demonstrated the benefit of the combination therapy over the individual components–a requirement for FDA approval of a fixed-dose combination.

In a second vehicle-controlled phase 3 BRIO-II study, Brimochol PF achieved all primary and secondary near vision improvement endpoints with statistically significant 3 lines or greater improvement in binocular uncorrected near visual acuity (BUNVA) over 8 hours, without the loss of 1 line or more in binocular uncorrected distance visual acuity (BUDVA). In addition, Brimochol PF was well-tolerated with no serious treatment-related adverse events observed in the over 70,000 treatment days monitored in the BRIO-II study.

Tenpoint submitted an NDA to the FDA in April 2025.