FDA Approves YUVEZZI: First Dual-Agent Eye Drop for Age-Related Near Vision Loss
TL;DR
The FDA has approved YUVEZZI (carbachol and brimonidine tartrate ophthalmic solution) 2.75%/0.1%, making it the first and only dual-agent eye drop approved to treat presbyopia in adults. Developed by Tenpoint Therapeutics, the once-daily preservative-free drop combines two established ophthalmic agents to provide sustained near vision improvement for up to 10 hours. The approval comes alongside $235 million in financing to support commercialization, with broad U.S. availability expected in Q2 2026.
Key Findings
- First-in-class combination therapy: YUVEZZI is the first FDA-approved dual-agent eye drop for presbyopia, combining carbachol 2.75% with brimonidine tartrate 0.1%.
- Phase 3 efficacy data: In the BRIO II study, YUVEZZI delivered statistically significant three-line or greater improvements in binocular uncorrected near visual acuity over an eight-hour period without loss of one line or more in distance visual acuity.
- Duration of effect: The treatment effect begins within 30 minutes of instillation and lasts up to 10 hours with once-daily dosing.
- Safety profile: Across more than 72,000 treatment days in BRIO II (the longest safety study conducted in presbyopia to date), no treatment-related serious adverse events were observed. The most common side effects were headache, eye irritation, temporary eye pain, and impaired vision.
- Reduced hyperemia: Ocular redness was less common in patients receiving YUVEZZI compared to those using carbachol alone.
- Superiority demonstrated: The BRIO I study showed YUVEZZI provided superior benefit compared to either individual active component alone, meeting FDA requirements for combination therapy approval.
How It Works
YUVEZZI creates a sustained "pinhole effect" through dual mechanisms of pupillary control. Carbachol, a cholinergic agent, produces constriction of the iris sphincter and ciliary body, narrowing the pupil to increase depth of focus. Brimonidine tartrate, an alpha-adrenergic agonist, blocks contraction of the iris dilator muscle and relaxes tonic contraction of the ciliary muscle. This dual approach enhances selectivity for the pupil while increasing the bioavailability of carbachol in the aqueous humor. The combination not only constricts the pupil but helps maintain that constriction throughout the day, addressing a key limitation of single-agent approaches.
Why This Matters
Presbyopia affects approximately 128 million people in the U.S. and 2 billion globally, yet pharmacological treatment options have been limited. While AbbVie's Vuity (pilocarpine) launched in 2021 as the first prescription eye drop for presbyopia, it hasn't achieved significant market penetration. Lenz Therapeutics' Vizz (aceclidine) received FDA approval in July 2025, and Orasis Pharmaceuticals' Qlosi launched in April 2025. YUVEZZI enters this growing category as the first combination product, potentially offering advantages in duration and tolerability that could drive broader adoption of pharmaceutical presbyopia management.
In Practice
Healthcare providers counseling patients on YUVEZZI should note several practical considerations:
- Dosing: One drop once daily, with effects beginning at 30 minutes and lasting up to 10 hours
- Formulation: Preservative-free, which may improve tolerability for chronic use
- Patient selection: Candidates include adults seeking alternatives to reading glasses for near vision tasks
- Monitoring: The label includes warnings about potential blood circulation problems and drug-drug interactions not present on some competitor labels
- Expectations: Patients should understand this corrects near vision through pupil modulation rather than restoring the lens's accommodative function
The Q2 2026 launch timeline gives pharmacy teams time to familiarize themselves with the product and identify appropriate patient candidates.
Beyond the Headline
YUVEZZI's path to approval reflects broader industry consolidation. The product was originally developed by Seattle-based Visus Therapeutics under the name BRIMOCHOL PF. In 2024, Visus merged with London-based Tenpoint Therapeutics, combining Visus's late-stage presbyopia asset with Tenpoint's investor base and early-stage cell therapy pipeline. Both active ingredients have decades of ophthalmic use: carbachol reached the market in 1972 for pupil constriction during cataract surgery, while brimonidine tartrate was commercialized in 1996 for ocular hypertension.
While YUVEZZI is the first combination therapy, some analysts remain cautious. William Blair analyst Lachlan Hanbury-Brown noted that competitor Vizz may have a stronger profile with data showing greater efficacy, faster onset, and longer durability in a broader population. The presbyopia eye drop market has yet to prove itself commercially, and YUVEZZI will be judged on whether its combination approach translates into real-world persistence and patient satisfaction.
Big Picture
The presbyopia eye drop category represents a test case for pharmaceutical solutions to age-related vision changes. With the global population aging and demand for non-surgical vision correction growing, successful products in this space could pave the way for expanded pharmaceutical approaches to other aspects of the aging eye. Tenpoint has indicated that cell therapy research remains part of its pipeline, though still preclinical.
The company has hired approximately two-thirds of its planned 76-person sales force targeting over 12,200 physicians across 8,800 offices. Combined with $235 million in fresh capital ($85 million Series B plus $150 million credit facility from Hercules Capital), Tenpoint appears positioned for an aggressive commercial launch. Whether YUVEZZI can succeed where earlier presbyopia drops have struggled will depend on demonstrating meaningful differentiation in efficacy, tolerability, and duration in real-world practice.
