Tenpoint wins FDA approval for presbyopia eye drop and raises $235 million

YUVEZZI is the first FDA-approved combination eye drop for presbyopia, an age-related loss of near vision. The approval was announced alongside an $85 million series B round and a $150 million loan with Hercules Capital.

The FDA decision clears the way for YUVEZZI to enter a market that has long relied on corrective lenses and, more recently, a small number of pharmacological eye drops.

The YUVEZZI path to FDA approval

YUVEZZI’s path to approval has been relatively short, at least on paper. Tenpoint Therapeutics only emerged in 2023, yet it now has an FDA-approved product on the market. This pace can be explained by how the company was put together. The drug we know today as YUVEZZI was originally Visus’ lead presbyopia candidate developed under the name BRIMOCHOL PF. 

In late 2024, Tenpoint Therapeutics and Visus merged to build a more robust ophthalmology pipeline with BRIMOCHOL PF being the most advanced candidate, and the two companies aiming for regulatory filing the year following the merger. And with the FDA approval in early 2026, Tenpoint did not miss that timing.

YUVEZZI is a fixed-dose combination eye drop that reflects the dominant pharmacological strategy in presbyopia: pupil modulation. The approach relies on narrowing the pupil to increase depth of focus, producing a pinhole effect that improves near vision. The eye drop combines carbachol, a muscarinic agonist that drives pupil constriction, with brimonidine tartrate, an alpha-2 adrenergic agonist that limits pupil dilation. 

It’s not only about making the pupil smaller, but it also has to stay that way for long enough to be useful to the patient. The combination also aims to avoid the trade-offs that earlier eye drops faced, with tolerability and loss of distance vision among the main concerns.

For fixed-dose combinations, regulators expect evidence that the combination itself adds value beyond its individual components. Across the two phase 3 studies, YUVEZZI delivered significant improvements in near vision, with effects extending up to eight hours after dosing.

In the trial, patients achieved a three-line or greater improvement in binocular uncorrected near visual acuity over that time frame (meaning they could read at least three additional lines on a standard near-vision eye chart without glasses), without losing one line or more of uncorrected distance vision. On the safety side, no treatment-related serious adverse events were reported, with the most common side effects limited to headache and transient ocular effects such as irritation or temporary visual disturbance.

Where YUVEZZI fits

While Tenpoint’s candidate is the first combined formulation to reach the market, it’s not the first eye drop indicated for presbyopia. The first modern entrant was AbbVie’s Vuity, approved in 2021 as a once-daily drop designed to improve near and intermediate vision by inducing miosis. AbbVie says the product can start working in as little as 15 minutes, with effects lasting up to six hours.

Two years later, the FDA approved Orasis Pharmaceuticals’ eye drop Qlosi, and more recently, in 2025, Vizz from LENZ Therapeutics. Beyond what is already approved, another late-stage contender is Opus Genetics (formerly Ocuphire Pharma), which is developing phentolamine ophthalmic solution for presbyopia. The pupil-modulating drop has completed its pivotal phase 3 trial, meeting its primary endpoint and positioning the program for a potential FDA submission. 

In that context, YUVEZZI will be judged less on novelty than on whether the combination can translate into real-world persistence. And with the $235 million funding that came at the same time as the FDA approval, Tenpoint is set to find out if its eye drop can differentiate itself on the market.