Yuvezi: FDA-Approved Eye Drops for Presbyopia | Carbachol & Brimonidine
- A new eye drop, January 28, 2026, received approval from the U.S.
- Presbyopia typically begins in our 40s, making it increasingly difficult to focus on close-up objects like reading material.
- The FDA’s approval of Yuvezzi was based on data from two phase 3 clinical trials, BRIO I and BRIO II.
A new eye drop, , received approval from the U.S. Food and Drug Administration (FDA) offering a novel approach to managing presbyopia, the age-related loss of near vision. Yuvezzi™ (carbachol and brimonidine tartrate ophthalmic solution) 2.75%/0.1% is the first and only FDA-approved dual-agent eye drop designed to address this common condition, affecting over 100 million Americans and an estimated two billion people worldwide.
How Yuvezzi Works
Presbyopia typically begins in our 40s, making it increasingly difficult to focus on close-up objects like reading material. Current management options include reading glasses, contact lenses and surgical procedures. Yuvezzi offers a pharmaceutical alternative by combining two active ingredients: carbachol and brimonidine tartrate. Carbachol, a cholinergic agonist, constricts the pupil. This constriction creates a “pinhole effect,” increasing depth of focus and improving near visual acuity. Brimonidine, an alpha-adrenergic receptor agonist, works to prolong the pupillary constriction induced by carbachol.
Clinical Trial Results
The FDA’s approval of Yuvezzi was based on data from two phase 3 clinical trials, BRIO I and BRIO II. BRIO I (ClinicalTrials.gov Identifier: NCT05270863) involved participants aged 45 to 80 with presbyopia. Participants were randomly assigned to receive Yuvezzi, carbachol alone, or brimonidine tartrate alone. BRIO II (ClinicalTrials.gov Identifier: NCT05135286) included participants, with receiving Yuvezzi and receiving a vehicle (placebo).
The primary endpoint of both trials was the proportion of patients achieving a gain of at least three lines (15 letters) in binocular uncorrected near visual acuity without experiencing a loss of one line (5 letters) or more in binocular uncorrected distance visual acuity under mesopic (intermediate light) conditions. Results from BRIO I demonstrated a statistically significant benefit with Yuvezzi compared to either carbachol or brimonidine alone. For example, at after administration, of patients using Yuvezzi achieved the primary endpoint, compared to with brimonidine () and with carbachol (). This benefit was sustained at multiple time points, with Yuvezzi consistently outperforming the individual components.
Safety and Tolerability
A safety study indicated that Yuvezzi was well-tolerated, with no serious adverse events reported. Compared to eye drops containing only carbachol, Yuvezzi was associated with reduced eye redness, potentially improving patient comfort and adherence.
Availability and Future Outlook
Yuvezzi is expected to be available to patients in the second quarter of . The approval of Yuvezzi represents a significant advancement in the treatment of presbyopia, offering a non-invasive option for individuals seeking to improve their near vision. According to Henric Bjarke, Chief Executive Officer of Tenpoint Therapeutics, the company that developed Yuvezzi, the approval is a “significant milestone for the millions of people in the U.S. Living with presbyopia and its daily frustrations and challenges.”
John Hovanesian, MD, principal and owner of Harvard Eye Associates, noted that the BRIO-I and BRIO-II trials, along with the extensive safety study, demonstrated Yuvezzi’s efficacy in allowing patients to see better at near distances without compromising distance vision – a key criterion for FDA approval.
What Which means for Patients
For individuals experiencing the gradual decline in near vision associated with presbyopia, Yuvezzi offers a potential alternative to traditional corrective measures. The once-daily drop may provide a convenient and effective way to manage the condition, reducing reliance on reading glasses or contact lenses. However, as with any medication, it’s important to discuss the potential benefits and risks with an eye care professional to determine if Yuvezzi is the right choice.
The development of Yuvezzi also highlights a growing trend in pharmaceutical approaches to age-related vision changes. The recent approval of Vizz (aceclidine) demonstrates increasing innovation in this area, providing patients with more options for maintaining clear vision throughout their lives.