PDUFA date set for January 2026, launch expected first half of year
The race to treat presbyopia just picked up speed. Tenpoint Therapeutics has announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for BRIMOCHOL™ PF, a fixed-dose combination eye drop designed to improve near vision in adults. The FDA has set a target action date of January 28, 2026, and notably, it does not intend to convene an advisory committee before making its decision.
Regulatory update and timeline
The FDA’s acceptance of the NDA marks an important step as Tenpoint shifts from development toward commercial readiness. BRIMOCHOL™ PF is a novel formulation combining carbachol and brimonidine in a preservative-free solution, designed to improve near vision by modulating the pupil.
In the announcement, Tenpoint confirmed that no advisory committee meeting is planned, which aligns with the FDA’s streamlined review for therapies meeting high evidentiary standards. A final decision is expected by late January 2026 under the Prescription Drug User Fee Act (PDUFA). If approved, the company anticipates commercial availability in the first half of next year.
“With our commercial leadership team now in place, we are fully engaged in launch preparations,” said Tenpoint CEO Henric Bjarke. “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.”
What is BRIMOCHOL™ PF?
BRIMOCHOL™ PF is a fixed-dose, preservative-free ophthalmic solution combining two agents: carbachol, a cholinergic miotic, and brimonidine tartrate, an alpha-2 adrenergic agonist. The combination is designed to constrict the pupil, creating a pinhole effect to increase depth of focus and improve near vision without significantly impairing distance vision or causing excessive visual side effects.1
The drop is aimed at addressing presbyopia, a condition that affects an estimated two billion people globally and remains largely underserved by pharmacologic treatments.2 Vuity (pilocarpine), approved in 2021, is the only other pharmacologic treatment but requires multiple daily doses and is associated with headaches and hyperemia.3 BRIMOCHOL™ PF’s once-daily regimen and combination mechanism aim to address these limitations.1
READ MORE: Zooming in on Presbyopia: Will we ever be free of reading glasses?
BRIMOCHOL™ PF has already completed two Phase III pivotal trials: BRIO-I and BRIO-II, which evaluated the safety, tolerability, and efficacy of the formulation. While specific trial data was not included in the announcement, the NDA acceptance indicates that the submitted results met the FDA’s threshold for formal review.
Clinicians may see the preservative-free formulation as a practical choice for daily use, especially given the link between preservatives and issues like ocular surface disease that send adherence rates spiraling.4
From clinical-stage to commercial-stage
With its NDA accepted and a PDUFA date set, Tenpoint Therapeutics is preparing to shift gears. The company, which has until now operated as a clinical-stage biotech, is laying the groundwork for its first commercial product launch.
CEO Henric Bjarke described the NDA acceptance as “a significant step forward” in the company’s growth strategy. He added that Tenpoint’s commercial leadership team is already in place and engaged in launch preparations ahead of a potential 2026 release.
Headquartered in both London and Seattle, Tenpoint is backed by a broad slate of global investors including EQT Life Sciences, F-Prime Capital, Sofinnova Partners and Hillhouse Capital. The company is also hitting the conference circuit, starting with the Jefferies Global Healthcare Conference in New York on June 3-4, 2025.
BRIMOCHOL™ PF is Tenpoint’s first step into pharmacologic presbyopia treatment, but the company’s sights are set wider—with active programs in cataracts and geographic atrophy too.
READ MORE: Presbyopia on the Table: What Works, What’s Next—Live from APAO 2025
What this means for eye care
- Tenpoint’s NDA for BRIMOCHOL™ PF has been accepted by the FDA, with a PDUFA date set for January 28, 2026.
- No advisory committee meeting is planned, suggesting a potentially smooth path through the regulatory process.
- If approved, BRIMOCHOL™ PF would be the only combination therapy of its kind for presbyopia, offering a differentiated mechanism of action.
- The company is preparing for commercial launch in the first half of 2026.
- BRIMOCHOL™ PF is part of Tenpoint’s wider mission to treat age-related vision loss, with additional programs for cataracts and geographic atrophy in development.
The road to 2026
With the NDA accepted, Tenpoint is in position to begin preparing for market launch. As BRIMOCHOL™ PF heads into final review, Tenpoint is already thinking beyond presbyopia, aiming to be more than a one-product player in a space that’s rapidly evolving. With the next regulatory milestone now clearly in sight, all eyes are on what comes after approval.
Editor’s Note:
- For more information, see the official press release from Tenpoint Therapeutics.
- This content is intended exclusively for healthcare professionals. It is not intended for the general public. Products or therapies discussed may not be registered or approved in all jurisdictions, including Singapore.
References
- Grzybowski A, Markeviciute A, Zemaitiene R. A review of pharmacological presbyopia treatment. Asia Pac J Ophthalmol (Phila). 2020;9(3):226–233.
- Fricke TR, Tahhan N, Resnikoff S, et al. Global prevalence of presbyopia and vision impairment from uncorrected presbyopia: systematic review, meta-analysis, and modelling. Ophthalmology. 2018;125(10):1492–1499.
- Drugs.com. Vuity FDA approval history. 2021. Available at: https://www.drugs.com/history/vuity.html Accessed on June 4, 2025.
- Kahook MY, Rapuano CJ, Messmer EM, et al. Preservatives and ocular surface disease: a review. Ocul Surf. 2024;34:213–224.