Less than 3 months after reporting positive phase 3 topline data, Tenpoint Therapeutics, Inc. announced it has submitted a new drug application (NDA) for BRIMOCHOL PF, a preservative-free (PF) ophthalmic solution for presbyopia.
First, let’s get the latest on the company.
While still a relatively young company (launching in 2023), the biotech startup made a major move in December 2024 to merge with Visus Therapeutics to focus on developing ocular therapeutics for “the aging eye.”
Its therapeutic targets:
- Presbyopia
- Presbyopia/cataract
- Geographic atrophy
And more recently: Just last month, the company named veteran executive Carol Kearney as its first chief commercial officer, tasked with leading efforts to launch and expand BRIMOCHOL PF.
Now talk about BRIMOCHOL PF.
Originally developed by Visus (and acquired via the Tenpoint merger), this fixed-dose ophthalmic solution is intended to be topically administered once a day.
Unique to BRIMOCHOL’s formulation is the inclusion of two FDA-approved pharmaceuticals:
- Carbachol (a cholinergic agent): Features a high potency and, as a miotic agent, provides increased duration of activity
- Brimonidine tartrate (a highly selective alpha-2 agonist): Prevents ciliary muscle contraction via alpha-2 receptor activation—potentially preventing miotic side effects
And how does it work on presbyopia?
The combination therapy creates and sustains a “pinhole effect” by reducing the pupil size to enable centrally-focused light rays to enter the eye.
The effect on presbyopia: This (ideally) results in improved depth of focus as well as sharper, sustainable vision and clarity for the following visual tasks:
- Near (such as reading or digital device usage)
- Intermediate (such as staring at a computer screen)
So about this NDA submission …
The submission package is supported by positive data from two phase 3 clinical trials: BRIO-I and BRIO-II (NCT05135286).
Important to note: The BRIO-I study was the first pivotal phase 3 trial on BRIMOCHOL PF, demonstrating a key requirement needed to support the FDA’s approval of a fixed-dose combination: the benefit of the solution’s combination therapy over the individual components.
And how else did BRIMOCHOL perform in these trials?
Sticking with BRIO-I: The company reported topline data in May 2023, in which the study achieved (beginning at hour 1) a ≥15 Early Treatment Diabetic Retinopathy Scale (ETDRS) letter gain in binocular near visual acuity (BNVA).
- Notably: This was achieved without losing ≥5 letters at distance across all time points through Hour 6 (carbachol p=0.006; brimonidine p=0.039).
And its performance in BRIO-II?
Positive findings from this 12-month study were released more recently—in January 2025.
As we previously reported: All prespecified primary endpoints were met, with BRIMOCHOL demonstrating"statistically significant improvements in near vision versus vehicle at all timepoints out to 8 hours (p<0.008).”
- As for adverse events (AEs): There were no reports of any serious treatment-related AEs.
How was pupil size affected?
Clinically and statistically significant reductions in pupil size at all time points supported the solution’s mechanism of action.
- Emphasizing the significance of the pupil size reduction, Tenpoint noted that this was achieved while also improving distance vision and providing a “gradual resolution of miosis over 10 hours.”
- Why this is important: With less miosis later in the day, presbyopia patients may have fewer vision difficulties at night.
So between the two trials, it sounds like BRIMOCHOL PF was well-tolerated.
Indeed. In fact, the company reported that BRIMOCHOL demonstrated a “favorable tolerability profile” with no reductions in efficacy over a 12-month duration (and 70,000+ dosing days of data).
Tenpoint’s Rhett Schiffman, MD, MS, MHSA, chief medical officer and head of Research and Development, added that additional patient benefits were observed beyond near vision improvements, including statistically significant increases in reading speed and statistically significant lower rates of hyperemia (eye redness) compared with carbachol (p=0.001).
- Plus: “Importantly, the rate of vitreous detachment was similar to vehicle,” he stated.
- See here for more insights.
Alrighty, now what’s next?
The FDA has 60 days to review the NDA submission and decide if it’s sufficient. If so, this could lead to a potential regulatory approval (and a tentative 2026 commercial launch).
- Check out what it’ll be looking for.