Tenpoint Therapeutics Submits NDA to FDA for Brimochol PF for the Treatment of Presbyopia
Tenpoint Therapeutics announced that the company has submitted a new drug application (NDA) to the FDA for Brimochol PF for the treatment of presbyopia.
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 sharpening 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 submission of the US NDA for Brimochol PF marks a significant milestone for our company,” Henric Bjarke, Chief Executive Officer at Tenpoint Therapeutics, said in a company news 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.”
The NDA submission is 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.
“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. “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=0.001) 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 hyperemia[3] 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 completeness and acceptability of the application for formal review.
References
- Zebardast N, Friedman DS, Vitale S. The prevalence and demographic associations of presenting near-vision impairment among adults living in the United States. Am J Ophthalmol. 2018;174:134-144.
- Verhoeven RS, Burke, J, Schiffman, R. Nonclinical Pharmacokinetics and Pharmacodynamics of Brimochol, a Combination Product for the Treatment of Presbyopia. Investigative Ophthalmology & Visual Science June 2022, Vol.63, 1819 – F0435. https://iovs.arvojournals.org/article.aspx?articleid=2780074
- Ackerman, S. L., Torkildsen, G. L., Mclaurin, E., & Vittitow, J. L. (2019). Low‐dose brimonidine for relief of ocular redness: integrated analysis of four clinical trials. Clinical and Experimental Optometry, 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.