FDA accepts NDA for Tenpoint Therapeutics' Brimochol PF for presbyopia

Tenpoint Therapeutics announced that the new drug application (NDA) for its presbyopia candidate, Brimochol preservative-free (PF), has been accepted by the FDA. The FDA has set a Prescription Drug User Fee Act (PDUFA) date of January 28, 2026. According to the press release, the FDA plans to hold an advisory committee meeting to discuss the NDA.¹

“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 press 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.”

Tenpoint Therapeutics submitted the NDA for Brimochol PF in April 2025. Brimochol PF is a unique entry into the presbyopia-correcting market due to a combination of brimonidine and carbachol in a pupil-modulating eye drop. The drop produces a pinhole effect to improve depth of focus sharpen near and distant impact to deliver greater peak efficacy and duration relative to monotherapy alone. This drop has the potential to be the first combination therapy for presbyopia.²

BRIO-II phase 3 clinical trial results

The NDA submission was supported by positive topline results from BRIO-II, a phase 3 pivotal trial investigating Brimochol PF. The 3-arm, multicenter, randomized, double-masked study investigated safety and efficacy. Investigators compared Brimochol PF with carbachol monotherapy and a vehicle topical ophthalmic solution in patients with emmetropic phakic or pseudophakic presbyopia. The trial met primary end points in both US and European Union/UK trials with a statistically significant visual acuity improvement at near. The improvements were recorded at all time points over 8 hours (P < .008). No serious adverse events were reported.³

Additionally, Brimochol PF demonstrated clinically and statistically significant reductions in pupil size at all time points in the study. This is the key to the pinhole effect the drop creates, and was cited as a key mechanism of action.³

In December 2024, Tenpoint and Visus Therapeutics merged. Prior to this merger, Brimochol PF was being investigated by Visus.⁴

References

1. Tenpoint Therapeutics Ltd. Announces FDA Acceptance of New Drug Application for BRIMOCHOL PF for the Treatment of Presbyopia. BusinessWire. Press release. Published June 3, 2025. Accessed June 3, 2025. https://www.businesswire.com/news/home/20250603104526/en/Tenpoint-Therapeutics-Ltd.-Announces-FDA-Acceptance-of-New-Drug-Application-for-BRIMOCHOL-PF-for-the-Treatment-of-Presbyopia

2. Joy J. Tenpoint Therapeutics submits NDA application to US FDA for Brimochol PF for the treatment of presbyopia. Optometry Times. Published April 8, 2025. Accessed June 3, 2025. https://www.optometrytimes.com/view/tenpoint-therapeutics-submits-nda-application-to-us-fda-for-brimochol-pf-for-the-treatment-of-presbyopia

3. Joy J. Tenpoint Therapeutics announces positive topline results from Phase 3 pivotal trial BRIO-II assessing BRIMOCHOL PF for the treatment of presbyopia. Optometry Times. Published January 9, 2025. Accessed June 3, 20205. https://www.optometrytimes.com/view/tenpoint-therapeutics-announces-positive-topline-results-from-phase-3-pivotal-trial-brio-ii-assessing-brimochol-pf-for-the-treatment-of-presbyopia

4. Hutton D. Tenpoint Therapeutics and Visus Therapeutics merge. Optometry Times. Published December 12, 2024. Accessed June 3, 2025. https://www.optometrytimes.com/view/tenpoint-therapeutics-and-visus-therapeutics-merge