Tenpoint Therapeutics Submits NDA for BRIMOCHOL PF to Treat Presbyopia

Tenpoint Therapeutics, Ltd. has announced the submission of a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for BRIMOCHOL PF for the treatment of presbyopia.1

Announced on April 8, 2025, BRIMOCHOL PF is a combination drug comprised of brimonidine and carbachol, administered as a once-per-day eye drop, which is targeted to sharpen both near and distant images and improve focus depth. If approved, BRIMOCHOL PF would become the first combination therapy for presbyopia, which currently impacts around 2 billion individuals worldwide, with 128 million in the US.2

“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”, said Rhett Schiffman, MD, MS, MHSA, Chief Medical Officer and Head of Research and Development at Tenpoint.1 “We also observed additional patient benefits beyond near vision improvements such as statistically significant increases in reading speed and significant lower rates of hyperemia compared with carbachol (P =.001) and importantly, the rate of vitreous detachment was similar to vehicle.”1

The NDA comes on the heels of positive data from the Phase 3 BRIO-II study, during which BRIMOCHOL PF achieved all primary endpoints for near vision improvement. BRIO-II was a multicenter, randomized, double-masked study involving 629 patients conducted in 47 locations from 2021-2024.

In the trial, BRIMOCHOL PF, a carbachol/brimonidine tartrate fixed-dose combination topical ophthalmic solution, was compared with carbachol monotherapy topical ophthalmic solution and vehicle topical ophthalmic solution in participants with emmetropic phakic or pseudophakic presbyopia.

Results indicated that BRIMOCHOL PF produced improvements in near vision at all timepoints (P <.008). Additionally, BRIMOCHOL PF showed clinically and statistically significant reductions in pupil size at all timepoints.3

The tests resulted in a ≥3-line improvement in binocular uncorrected near visual acuity (BUNVA) over the course of 8 hours, without the loss of one line or more in binocular uncorrected distance visual acuity (BUDVA). BRIMOCHOL PF also triggered no adverse events during treatment over the more than 70,000 treatment days in the study.1

“The increase in peak effect and duration of BRIMOCHOL PF over carbachol alone, along with the decreased incidence of hyperemia and the lower rate of vitreous detachment are all consistent with previously reported mechanisms of action of brimonidine or related compounds,” Schiffman said.1

According to the press release, the FDA will be conducting a standard 60-day review to determine the completeness and acceptability of the application for formal review.1

References

1. Tenpoint Therapeutics, Ltd. Tenpoint Therapeutics Ltd. Submits New Drug Application to U.S. FDA for BRIMOCHOL™ PF for the Treatment of Presbyopia. Tenpoint Therapeutics, Ltd. April 8, 2025. Accessed April 8, 2025. https://cdn.prod.website-files.com/64b01a75c3f993c7c15191dd/67f445e57c7031c517c9de43_BRIMOCHOL%20NDA%20PR%20(March%202025)_FINAL.pdf

2. Singh P, Tripathy K. Presbyopia. [Updated 2023 Aug 25]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK560568/

3. Tenpoint Therapeutics, Ltd. Tenpoint Therapeutics Announces Positive Topline Data from Phase 3 Pivotal Study, BRIO-II, of BRIMOCHOLTM PF for the Treatment of Presbyopia. Tenpoint Therapeutics, Ltd. Jan 9, 2025. Accessed April 8, 2025. https://cdn.prod.website-files.com/64b01a75c3f993c7c15191dd/677ff7ffefa72f00cca150c7_PR%20Tenpoint%20Announces%20Positive%20Topline%20Clinical%20Data_8Jan2025_1pm.pdf