Tenpoint Submits NDA for BRIMOCHOL PF

Tenpoint Therapeutics, a clinical-stage biotechnology company, has announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for BRIMOCHOL PF, a pupil-modulating eye drop candidate developed for the treatment of presbyopia.

BRIMOCHOL PF: A Fixed Combination Therapy for Presbyopia

BRIMOCHOL PF is a preservative-free ophthalmic formulation that combines:

• Brimonidine, an alpha-2 adrenergic receptor agonist

• Carbachol, a cholinergic agonist

This dual mechanism creates a pinhole effect, designed to enhance depth of focus and improve both near and distance vision, offering greater peak efficacy and extended duration compared to monotherapies.

If approved, BRIMOCHOL PF would become the first combination eye drop therapy for presbyopia.

Clinical Data Supporting NDA Submission

The NDA submission is supported by results from two pivotal Phase 3 clinical trials:

BRIO-I Trial

• Demonstrated that the combination therapy outperformed its individual components

• Met the FDA requirement for fixed-dose combination approval

BRIO-II Trial

• A vehicle-controlled study assessing efficacy and safety

• Achieved all primary and secondary endpoints, including:

- Statistically significant 3-line or greater improvement in binocular uncorrected near visual acuity (UNVA) over 8 hours

- No loss of 1 line or more in binocular uncorrected distance visual acuity (UDVA)

• Well tolerated, with no serious treatment-related adverse events reported over 70,000 treatment days

Long-Term Safety and Additional Benefits

According to Dr. Rhett Schiffman, Chief Medical Officer and Head of R&D at Tenpoint, the NDA includes data from the largest and longest (12 months) efficacy and safety study conducted in presbyopia to date.

Key findings included:

• Sustained efficacy with no reduction over time

• Statistically significant increase in reading speed

• Lower rates of hyperemia compared to carbachol monotherapy (p=0.001)

• Comparable rates of vitreous detachment to vehicle group

These findings are consistent with the mechanisms of action previously reported for brimonidine and related compounds.

Regulatory Outlook

The FDA will conduct a standard 60-day filing review to determine whether the NDA is accepted for formal review.

Company Commentary

“The submission of the U.S. NDA for BRIMOCHOL PF marks a significant milestone for our company,” said Henric Bjarke, CEO of Tenpoint Therapeutics. “As we accelerate the build-out of our commercial team in preparation for the anticipated launch in the first half of 2026, we are incredibly proud of the dedication and tireless work that has brought the company to this point. We look forward to collaborating closely with the FDA throughout the NDA review process.”

References:

Verhoeven RS, Burke, J, Schiffman, R. Nonclinical Pharmacokinetics and Pharmacodynamics of Brimochol, a Combination Product for the Treatment of Presbyopia. Invest Ophthal & Vis Sci. 2022;63:1819-F0435. https://iovs.arvojournals.org/article.aspx?articleid=2780074

Ackerman SL, Torkildsen GL, Mclaurin E, & Vittitow JL. Low‐dose brimonidine for relief of ocular redness: integrated analysis of four clinical trials. Clin and Exper Opt. 2019;102(2):131–139. https://doi.org/10.1111/cxo.12846

Kubo C, Suzuki R. Involvement of prejunctional alpha 2-adrenoceptor in bovine ciliary muscle movement. J Ocul Pharmacol. 1992;8(3):225-31.