Tenpoint Therapeutics, a global biotechnology company focused on treatments for age-related vision conditions, has received approval from the US Food and Drug Administration (FDA) for Yuvezzi (carbachol and brimonidine tartrate ophthalmic solution) 2.75 percent/0.1 percent. The therapy is the first and only FDA-approved dual-agent eye drop for the treatment of presbyopia in adults.

Presbyopia, the gradual loss of near vision typically beginning around age 45, affects approximately 128 million people in the United States and nearly two billion globally. Yuvezzi is expected to become broadly available across the US in the second quarter of 2026.

The FDA approval was supported by positive data from two Phase III clinical trials, BRIO I and BRIO II. The BRIO I study demonstrated that the fixed-dose combination delivered superior efficacy compared to either active ingredient alone, meeting a key regulatory requirement. In BRIO II, a vehicle-controlled trial, Yuvezzi met all primary endpoints, achieving statistically significant improvements of three lines or more in binocular uncorrected near visual acuity (BUNVA) for up to eight hours, without compromising distance vision.

The treatment also showed a favourable safety profile. Across more than 72,000 treatment days in the 12-month BRIO II study—the longest presbyopia safety study conducted to date—no treatment-related serious adverse events were reported. The most common side effects included headache, temporary eye irritation and mild visual disturbance. Reports of ocular hyperemia (eye redness) were low and occurred less frequently in patients receiving Yuvezzi compared to carbachol alone.

Yuvezzi works through a dual mechanism of action. Carbachol, a cholinergic agent, constricts the iris sphincter and ciliary body, while brimonidine tartrate, an alpha-adrenergic agonist, enhances pupillary selectivity and improves bioavailability. Together, they create a “pinhole effect,” improving near visual acuity and depth of focus.

Henric Bjarke, CEO, Tenpoint Therapeutics, described the approval as a significant milestone for individuals living with presbyopia. He noted that Yuvezzi provides sharp near vision with favourable tolerability, offering a convenient alternative to traditional solutions such as glasses, contact lenses or surgery.

Eye care specialists also highlighted the importance of the approval. Dr. John Hovanesian of Harvard Eye Associates said the therapy represents a novel, non-invasive option that combines efficacy with daily usability. Dr. Mile Brujic of Premier Vision Group added that Yuvezzi offers a practical long-term solution for patients seeking lifestyle-friendly management of near vision challenges.

Carol Kearney, Chief Commercial Officer at Tenpoint Therapeutics, stated that the company designed Yuvezzi to balance effectiveness, tolerability and ease of use, ensuring it integrates seamlessly into patients’ professional and personal lives.

The approval marks Tenpoint’s first commercial therapy aimed at addressing vision challenges associated with the aging eye and reinforces its mission to advance innovation in ophthalmology.