Tenpoint Therapeutics, Limited and Visus Therapeutics, Inc. have completed their merger, announcing a joint focus on ophthalmic therapeutic medicines for “rejuvenating the aging eye.
To note: The companies are uniting under the Tenpoint name.
First up: some background on these players.
We’ll start with Tenpoint.
The global, clinical-stage biotechnology company launched in July 2023 with a focus on advancing engineered cell-based therapies and in vivo programming for vision restoration in patients diagnosed with degenerative ocular disease.
Its research: Involves the development of a regenerative medicine platform for replacing cells damaged by age-related and inherited ocular diseases.
- Learn more about the company’s science here.
Now Visus.
As a clinical-stage pharmaceutical company, Visus specialized in developing ophthalmic therapies—with an emphasis on addressing presbyopia-related vision loss.
Its lead asset: BRIMOCHOL PF.
About this merger … any details to know about?
While no financial details were disclosed, the company did note a leadership change:
Henric Bjarke, a veteran executive of the pharmaceutical industry and former CEO of ACM Biosciences AG, has been named CEO of the newly-merged company.
Let’s circle back to BRIMOCHOL: Talk about this asset.
Now at the forefront of Tenpoint Therapeutics, Limited, BRIMOCHOL PF is a topical, preservative-free, and fixed-dose ophthalmic solution comprised of two FDA-approved formulations:
- Carbachol
- A cholinergic agent known for its potency and increased duration of activity as a miotic agent.
- tTranslation: it reduces the size of the pupil, leading to near visual acuity (VA) improvement—via pupil constriction.
- Brimonidine tartrate
- A highly selective alpha-2 agonist that prevents ciliary muscle contraction by way of alpha-2 receptor activation.
- This sympatholytic agent’s potential includes mitigating miotic side effects.
- A highly selective alpha-2 agonist that prevents ciliary muscle contraction by way of alpha-2 receptor activation.
Explain how this formulation works.
BRIMOCHOL creates and sustains a “pinhole effect” by reducing the pupil size to allow only centrally-focused light rays to enter the eye.
- The result: Enhanced, sustainable vision and clarity for near (i.e., reading, smartphone/tablet use) and intermediate visual tasks (i.e., staring at a computer screen).
As far as dosing: This eye drop is intended to be administered once daily.
And where is it at in the clinical development process?
The eye drop was evaluated in two phase 3 trials (BRIO-I and BRIO-II; both completed).
Our last coverage on BRIMOCHOL was back in May 2023, when topline data was released from the 3-arm, multicenter, double-masked, randomized, safety and efficacy pivotal phase 3 BRIO-I trial (NCT05135286).
The study evaluated nearly 200 patients (aged 45 to 80) with emmetropic phakic and pseudophakic presbyopia.
Those findings: BRIMOCHOL met the primary endpoint, achieving—beginning at hour 1—a ≥15 Early Treatment Diabetic Retinopathy Scale (ETDRS) letter gain in binocular near visual acuity (BNVA) without a loss of ≥5 letters at distance across all time points through Hour 6 (carbachol p=0.006; brimonidine p=0.039).
- See more promising data.
What was significant about BRIMOCHOL’s performance?
As we previously reported, the fixed-dose combination product was the first of its kind to achieve the FDA’s requirement of statistically significant “contribution-of-elements” in presbyopia.
Translation: It reached uncharted territory in the presbyopia drop space.
And what’s the plan for its clinical journey?
Tenpoint reported that BRIMOCHOL is on track for a new drug application (NDA) filing to the FDA in H1 2025 (meaning sometime in Q1 or Q2).
The goal: A tentative U.S. commercial launch by H1 2026.
How exciting! And what else is in the pipeline for the joint company?
Two other clinical programs, both currently in the preclinical stage.
- TPT-161, a novel small molecule intended to reverse cataract formation in aging adults
- Also in development for presbyopia, this is a new chemical entity (NCE) that treats and reverses lens protein aggregation to restore lens flexibility and clarity
- TPT-005, a cell therapy targeting retinal pigment epithelium (RPE) cell replacement for geographic atrophy (GA)
- Designed as a sub-retinal injection