Tenpoint Therapeutics submits NDA application to FDA for BRIMOCHOL PF for the treatment of presbyopia

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Clinical-stage biotechnology company Tenpoint Therapeutics has announced its new drug application (NDA) submission to the FDA for BRIMOCHOL PF for the treatment of presbyopia.¹ BRIMOCHOL PF has the potential for a best-in-class product profile due to its unique combination of brimonidine and carbachol in a pupil-modulating eye drop, according to a news release.

“The submission of the U.S. NDA for BRIMOCHOL PF marks a significant milestone for our company,” said Henric Bjarke, Tenpoint Therapeutics CEO, in the release. “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.”

BRIMOCHOL PF’s combination of brimonidine and carbachol produces a “pinhole effect,” which is intended to improve depth of focus and sharpen near and distant impact, benefiting the patient with greater peak efficacy and duration relative to monotherapy alone, according to the release. If approved by the FDA, this formulation would be the first combination therapy for presbyopia.¹

Tenpoint’s NDA submission is supported by positive data from the first pivotal phase 3 BRIO-I trial, which demonstrated the benefit of the combination therapy over individual component. The company noted that this is a requirement for FDA approval of a fixed-dose combination. Additionally, BRIMOCHOL PF achieved all primary and secondary near vision improvement end points in a second vehicle-controlled phase 3 BRIO-II trial. Results were statistically significant with 3 lines or greater improvement in binocular uncorrected near visual acuity over 8 hours without the loss of 1 line or more in binocular uncorrected distance visual acuity. The therapy was well tolerated with no serious treatment-related adverse events over a total of 70,000 treatment days in the BRIO-II trial.¹

“The NDA submission includes data from the world’s largest and longest (12 months) efficacy and safety study in presbyopia, with more than 70,000 dosing days of data. BRIMOCHOL PF demonstrated a very favorable tolerability profile and no reduction in efficacy over the 12-month study duration,” said Rhett Schiffman MD, MS, MHSA, chief medical officer and head of research and development at Tenpoint, in the release. “We also observed additional patient benefits beyond near vision improvements, such as statistically significant increases in reading speed and significant lower rates of hyperemia (eye redness) compared with carbachol (P=.001) and importantly, the rate of vitreous detachment was similar to vehicle. The increase in peak effect and duration of BRIMOCHOL PF over carbachol alone,² along with the decreased incidence of hyperemia³ and the lower rate of vitreous detachment,⁴ are all consistent with previously reported mechanisms of action of brimonidine or related compounds.”

The FDA will conduct a standard 60-day filing review to assess the application for formal review.

References

1. Tenpoint Therapeutics Ltd submits new drug application to US FDA for BRIMOCHOL PF for the treatment of presbyopia. News release. Tenpoint Therapeutics, Ltd. April 8, 2025. Accessed April 8, 2025. https://www.businesswire.com/news/home/20250408026931/en/Tenpoint-Therapeutics-Ltd.-Submits-New-Drug-Application-to-U.S.-FDA-for-BRIMOCHOL-PF-for-the-Treatment-of-Presbyopia

2. 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

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

4. Kubo C, Suzuki R. Involvement of prejunctional alpha 2-adrenoceptor in bovine ciliary muscle movement. J Ocul Pharmacol. 1992;8(3):225-231.