On July 31st, the FDA approved a drug to treat a condition that will affect virtually every person in the world. After age 40, almost everyone develops presbyopia, or the progressive farsightedness that happens due to aging. Over time, the lens of the eye stiffens, causing it to become more difficult for the eye muscles to contract the lens to focus on close-by objects.
The standard treatment is reading glasses or bifocal glasses as they are a simple, affordable, and widely available option. However, they are also easy to misplace and inconvenient to use throughout the day. The rise of presbyopia-correcting eye drops could offer a non-invasive, easy-to-use alternative that lasts the whole day. The first eye drops to enter the market, Vuity from AbbVie and Qlosi from Orasis Pharmaceuticals, were approved by the FDA in 2021 and 2023, respectively. Both drugs use pilocarpine, a cholinergic agonist, to constrict the pupil and create a “pinhole effect” that makes it easier to focus on and see near objects clearly.
Now, the recent approval of Vizz eye drops from LENZ Therapeutics marks the first time that the FDA has approved a drug using a novel cholinergic agonist, aceclidine, for any indication. The compound, which was approved in Europe to treat glaucoma in the 1970s, offers a more selective approach than prior eye drops by mainly acting on the iris sphincter muscle to constrict the pupil and not also the ciliary muscle — as Vuity and Qlosi do. This specificity has led to an improved side effect profile and a lack of a myopic shift, or an increase in nearsightedness over time, that can occur with Vuity.
Fewer side effects
The FDA approval of Vizz was based on the Phase 3 trials of 217 patients, which showed that Vizz met its endpoints to improve near vision by at least three lines on a vision chart in up to 71 percent of patients after just 30 minutes, with effects lasting up to 10 hours after once-daily dosing. This makes Vizz the longest-acting option after just a single dose, with both Vuity and Qlosi requiring a second dose to achieve up to 8–10 hours duration.
In a press release, LENZ Therapeutics reported that the drug did not lead to any serious treatment-related side effects, and the most common reactions included transient site irritation, dim vision, and headache. As expected due to minimal effects on the ciliary muscle, Vizz was less likely to lead to brow aches and blurry distance vision seen more frequently with Vuity and Qlosi.
LENZ Therapeutics announced that they plan to have the product available by mid-Q4 of this year. “We are ready and excited to launch the first and only once-daily eye drop with proven efficacy for up to 10 hours into the market,” said Eef Schimmelpennink, President and Chief Executive Officer of LENZ Therapeutics, in the statement.
A more selective mechanism
With the global presbyopia treatment market size projected to grow to reach $16.47 billion in 2033, eye drops like Vizz could become the drug of choice for many. Others could also be approved soon, with a decision on brimochol from Tenpoint Therapeutics expected in January 2026. Their drug uses a different cholinergic agonist, carbachol, paired with the adrenergic agonist brimonidine; however, carbachol is also less selective than aceclidine, acting on both the ciliary muscle and the iris sphincter muscle to constrict the pupil, similar to pilocarpine in Vuity and Qlosi. Another drug in development from Opus Genetics and Viatris that recently completed Phase 3 trials uses a different mechanism of action by targeting adrenergic receptors.
The approval of Vizz illustrates the importance of developing targeted medications with few side effects in drug discovery and development. Though the active ingredient, aceclidine, was originally synthesized in the 1960s, it fell out of favor in treating glaucoma because its high concentration led to greater systemic exposure and side effects. The pupil-selective mechanisms of aceclidine, and thus the potential for it to be used in smaller doses as a treatment for presbyopia, led LENZ Therapeutics to begin its CLARITY clinical trials.
“This FDA approval represents a disruptive paradigm shift in treatment options for millions of people who are frustrated and struggling with the inevitable age-related loss of their near vision,” said Marc Bloomenstein, an optometrist and Vizz clinical investigator at the Schwartz Laser Eye Care Center, in the press release. “I believe this will be a welcome solution for both optometrists and ophthalmologists who will now be able to offer a highly effective and sought-after presbyopia treatment that could immediately become the standard of care, with a product profile that will meet our patients’ needs.”
This article is part of our 2025 Novel FDA Approvals series, highlighting groundbreaking therapies that received FDA approval this year. Each story explores the science, clinical impact, and future potential of these innovative treatments shaping the next era of medicine.
