FDA Approves Use of Eye Drops that Eliminate the Use of Glasses

By Viviana Cetola

Reporter, Life News Today

The U.S. Food and Drug Administration (FDA) has approved Vizz (aceclidine ophthalmic solution 1.44%) for the treatment of presbyopia in adults.

What is presbyopia?

If you are over 40 years old and experience blurry vision, especially up close, there is a possibility that it is presbyopia. It is, in fact, the first result when you get when you Google "I see a little blurry", but we emphasize again that this search engine is not a reliable source of diagnosis. Presbyopia consists of a considerable decrease in the ability to focus on objects from up close, especially if they are small, but it is better to treat it in time so that vision does not deteriorate quickly. The symptoms that can denote that one suffers from presbyopia are headache and tired vision. And this, in the long run, can become extremely cumbersome and affect quality of life.

The FDA has just approved Vizz, the first aceclidine eye drops that bring back the ability to read without glasses for up to 10 hours with a single daily application. The drug is called Vizz and its application to the eye gently contracts the pupil thanks to aceclidine. This topical ocular medication comes in single-dose vials and is applied once a day, with two drops in each eye two minutes apart.

According to the pharmaceutical company LENZ Therapeutics, creator of Vizz, the compound causes what scientists call a "pinhole effect" similar to when the diaphragm of a camera is narrowed. This constriction of the pupil extends the depth of field of the eye and allows you to focus on nearby objects with total clarity. In addition, unlike similar treatments developed previously, Vizz manages to contract the pupil to less than 2 millimeters without significantly affecting the focusing muscles of the eye.

The FDA's approval is based on three randomized, double-blind clinical trials, the most rigorous because neither doctors nor patients know whether the treatment has the active ingredient or the placebo and the controls of Phase 3. The first two studies evaluated safety and efficacy in 466 participants who received doses once daily for 42 days, while the third followed 217 participants for six months. The company assures that in the first two trials Vizz achieved all the objectives, demonstrating the ability to improve near vision in 30 minutes and with a duration of up to 10 hours. In addition, the improvement in near vision was reproducible and consistent in both studies. "Vizz was well tolerated with no serious adverse effects observed in the more than 30,000 days of treatment across the three trials," the company explains. There were also some side effects such as irritation at the instillation site (20%), dim vision (16%) and headache (13%). "Most of the adverse reactions were mild, transient and resolved on their own," they say. In Phase 3 clinical trials, Vizz demonstrated significant vision improvement within three hours of administration, with an onset of effect within 30 minutes and lasting up to ten hours. The studies included people aged between 45 and 75 years, some with a history of refractive surgery or pseudophakia.

However, the FDA warns of frequent adverse effects. Among the most common are irritation at the site of application (20% of participants), temporary dim or "dark" vision (16%), and headache (13%). Cases of conjunctival hyperemia (8%) and ocular hyperemia (7%) were also recorded, both showing redness of the white part of the eye due to inflammation and dilation of the blood vessels. It is not a disease in itself, but a common symptom caused by conjunctivitis (infectious or allergic), eye strain, dryness, or external irritants. Most of these reactions were mild, transient, and resolved on their own.

The official package inserts issued by the FDA also includes specific precautions. It is recommended not to drive or operate machinery if vision is not clear, to be extremely cautious when driving at night and to undergo a retinal examination before starting treatment, due to rare cases of retinal tearing or detachment with the use of miotics, which are medications that cause the pupil to contract (miosis) and improve the drainage of the aqueous humor. Its main use is to reduce intraocular pressure (IOP) in glaucoma patients and, at lower concentrations, to improve near vision in people with presbyopia. The drug should be used with caution in people with a history of iritis, which is inflammation of the colored part of the eye (the iris). It is also known as anterior uveitis and is not recommended in patients with hypersensitivity to any of its components.

Although the clinical trials supporting the approval of Vizz demonstrated rapid and sustained improvements in near vision, their design has significant limitations: the maximum duration of follow-up was 42 days in the efficacy studies (CLARITY-1 and CLARITY-2) and six months in the long-term safety study (CLARITY-3), which makes it impossible to know the efficacy and safety profile beyond that period in a chronic condition such as presbyopia. In addition, the study population had a limited refractive range and only included some patients with previous eye surgeries, which reduces the certainty about extrapolating the results to the entire population with presbyopia, especially those with other concomitant eye pathologies.