The US Food and Drug Administration (FDA) has approved carbachol and brimonidine tartrate ophthalmic solution 2.75%/0.1% (YUVEZZI) for the treatment of presbyopia in adults, representing the first regulatory authorization of a fixed-dose, dual-agent topical therapy for age-related near vision degradation, according to Tenpoint Therapeutics.
Announced on January 28, 2026, this approval expands the pharmacologic armamentarium for presbyopia, a ubiquitous condition historically managed with corrective lenses or surgical procedures.1
“The impact of presbyopia is often underestimated, and current solutions like glasses, contacts or surgery have fallen short in meeting the real-world needs of people who struggle with close-up tasks,” said John Hovanesian, MD, of Harvard Eye Associates in Laguna Hills, California.1 “YUVEZZI introduces a novel approach by combining carbachol and brimonidine tartrate in a single daily eye drop that sharpens near vision and maintains tolerability throughout the day. YUVEZZI was intentionally designed to deliver both efficacy and tolerability, which represents an important step forward in delivering a complete, non-invasive option for people with presbyopia.”
Mechanism of Action
According to the announcement from Tenpoint Therapeutics, the combination therapy acts through controlled pupillary constriction (“pinhole effect”) to improve near visual performance by enhancing depth of focus while minimizing adverse effects on distance vision. Carbachol stimulates the iris sphincter and ciliary muscles, and brimonidine reduces dilator activity while potentially increasing carbachol bioavailability in the aqueous humor. This dual approach differs from single-agent miotics in theoretical mechanism, although clinical significance awaits peer-reviewed publication of head-to-head data.
Clinical and Regulatory Evidence
The FDA’s decision was supported by results from a pair of pivotal phase 3 trials, BRIO I and BRIO II, conducted in adults with presbyopia. BRIO I was designed to satisfy fixed-dose combination regulatory requirements by demonstrating that the combined therapy provided superior near vision benefit compared with its individual components.
In the vehicle-controlled BRIO II study, carbachol and brimonidine tartrate ophthalmic solution 2.75%/0.1% met all primary efficacy endpoints. According to sponsor data, the formulation produced statistically significant ≥3-line improvement in binocular uncorrected near visual acuity (BUNVA) over an 8-hour period without inducing a loss of ≥1 line in binocular uncorrected distance visual acuity (BUDVA). The extended safety component of BRIO II monitored more than 72,000 treatment days over 12 months, which the sponsor described as the longest safety database for any presbyopia eye drop to date.
Reported adverse events included headache, transient visual disturbance, and temporary ocular discomfort. Rates of ocular hyperemia (eye redness) were reportedly low and appeared lower in the carbachol and brimonidine tartrate ophthalmic solution 2.75%/0.1% arm (2.8%) versus carbachol monotherapy (10.7%) in BRIO II. No treatment-related serious adverse events were observed, although prespecified, adjudicated safety outcomes and independent monitoring details have not yet been published.
Presbyopia Treatment Landscape
Until 2021, presbyopia management was limited to physical aides or surgical options. In October 2021, the FDA approved pilocarpine hydrochloride 1.25% ophthalmic solution (Vuity) as the first topical pharmacologic therapy for presbyopia, using a pupil-constricting or “pinhole” mechanism to improve near vision while preserving distance acuity. The market has since expanded, with additional agents such as aceclidine solution (VIZZ) approved in 2025 as an alternative miotic option.
Existing topical therapies primarily rely on pupillary miosis to increase depth of focus, though dosing regimens, effect duration, and side-effect profiles vary among agents. According to Tenpoint Therapeutics, the unique contribution from carbachol and brimonidine tartrate ophthalmic solution 2.75%/0.1% lies in its combination of a cholinergic agonist (carbachol) with an α-adrenergic agent (brimonidine tartrate) intended to enhance pupil modulation and theoretically improve tolerability and duration. Comparative data against established drops such as pilocarpine or aceclidine are not yet publicly available.
References
Fricke TR, Tahhan N, Resnikoff S, et al. Global prevalence of presbyopia and vision impairment from uncorrected presbyopia: systematic review, meta-analysis and modelling. Ophthalmology. 2018;125(10):1492–1499. https://doi.org/10.1016/j.ophtha.2018.04.013
