Tenpoint Therapeutics is a biopharmaceutical company dedicated to developing new treatments for age-related eye conditions. Their innovative therapies aim to restore sight and improve ocular health, advancing the field of ophthalmology through research and development.
Addressing Age-Related Vision Loss
Tenpoint Therapeutics focuses on three specific age-related eye conditions: presbyopia, cataracts, and geographic atrophy. Presbyopia is a common condition where the eye’s natural lens becomes less flexible with age, making it difficult to focus on close-up objects, such as reading a book or using a smartphone. This condition affects approximately 2 billion people globally.
Cataracts involve the clouding of the eye’s natural lens, which can lead to blurred vision, glare, and difficulty seeing in low light. This clouding occurs when proteins within the lens begin to misfold and clump together, scattering and distorting light as it passes through.
Geographic atrophy (GA) represents an advanced form of dry age-related macular degeneration (AMD), characterized by the progressive loss of retinal pigment epithelium (RPE) cells and photoreceptors in the macula. This cell loss leads to distinct patches of atrophy, causing a gradual and permanent loss of central vision, which can severely impact daily activities like reading or recognizing faces.
Leading Product Candidates
Tenpoint Therapeutics is developing several product candidates to address these age-related vision conditions. BRIMOCHOL PF is a lead product candidate for presbyopia. This once-daily, preservative-free eye drop combines carbachol, which constricts the pupil, and brimonidine tartrate, an alpha-2 agonist. This combination creates a “pinhole effect” by reducing pupil size, allowing only centrally focused light rays to enter. This sharpens distant and near images and enhances depth of focus. Clinical trials show BRIMOCHOL PF improves near vision for up to 10 hours with a single drop and has a favorable tolerability profile.
TPT-161 is a program for cataracts. This investigational small molecule is designed to reverse cataracts by targeting two mechanisms of lens opacity and hardening: protein misfolding and disulfide bond formation. TPT-161 acts as a co-drug, combining an alpha-crystallin chaperone with a reducing agent. The alpha-crystallin chaperone binds to and stabilizes alpha-crystallin, preventing protein aggregation. The reducing agent breaks down disulfide bonds, restoring lens clarity and flexibility.
Another program, TPT-005, is a cell therapy for geographic atrophy. This therapy involves an allogeneic cell suspension of Retinal Pigment Epithelium (RPE) cells derived from human embryonic stem cells. These RPE cells are differentiated and expanded in a laboratory setting to exhibit the functions, morphology, and pigmentation characteristic of natural RPE cells. TPT-005 is intended to be administered via sub-retinal injection, with the goal of replacing the lost RPE cells in patients with geographic atrophy. By replacing these damaged cells, TPT-005 aims to re-establish a functional RPE cell layer and restore vision lost to geographic atrophy.
Company Milestones and Future Outlook
Tenpoint Therapeutics recently merged with Visus Therapeutics, consolidating their ophthalmic therapeutic portfolios. The combined entity operates under the Tenpoint Therapeutics name, bringing together a robust pipeline for presbyopia, cataracts, and geographic atrophy. This strategic consolidation aims to accelerate the development and commercialization of their innovative therapies.
A near-term milestone for the company is the New Drug Application (NDA) filing for BRIMOCHOL PF for presbyopia. The NDA was submitted to the US Food and Drug Administration (FDA) in the first half of 2025. This submission is supported by data from pivotal Phase 3 trials, including a 12-month safety and efficacy study. The FDA has accepted the NDA for review, with a Prescription Drug User Fee Act (PDUFA) target action date of January 28, 2026. If approved, BRIMOCHOL PF would be the first combination therapy for presbyopia, potentially launching in the first half of 2026.