Category: New Drug Approval
Written By: Dewanshee Ingale, BPharm
Medically Reviewed By: Dr. Mayur Jawale, MBBS, MS (Ophthalmology)
LENZ Therapeutics received a FDA approval for VIZZ. VIZZ is preservative free aceclidine ophthalmologic solution which the first and one and only FDA approved aceclidine based eye-drop for the treatment purpose of presbyopia, marking an important breakthrough in presbyopia management which affects an estimated 128 million adults in the U.S.
Presbyopia refers to the age-related loss of near vision mostly in elderly people. VIZZ manages the presbyopia by giving a novel, convenient and an efficient therapeutic solution. It shows its action in 30 minutes and offers clear near vision that stays up to 10 hours.
LENZ Therapeutics is a late-stage clinical biopharmaceutical company based in San Diego, California. LENZ is especially focused on treating presbyopia the age-related decline in near vision that affects an estimated 1.8 billion people globally.
About VIZZ
VIZZ (aceclidine ophthalmic solution 1.44%) is precisely developed by LENZ Therapeutics for the management of presbyopia using recent pharmaceutical formulation methods. This eye-drop is administered directly into the eyes by a small, single-use vial which is compact, lightweight and very simple to use, offering convenience to patients for daily use of drops. The unique composition of drop gives a predictable onset of action in 30 minutes which lasts up to 10 hours. It provides particle properties and solution characteristics that are meticulously engineered for optimal ocular absorption and patient comfort for administration.
VIZZ works by gently contracting the iris sphincter muscle, which makes the pupil smaller like a “pinhole effect”. This increases the depth of focus and improves near vision, like adjusting a camera lens. Because it mainly acts on the iris and not the ciliary muscle, it helps you see up close without causing blur at distance or a myopic shift.
Present data and background
Presbyopia is very common age related issue that impairs the ability of eyes to focus on the near objects, it typically starts beyond the age of 40 and it affects over 1.8 billion people in the world. There are traditional management solutions available like the reading glasses or certain surgical procedure. Hence there is a need of less invasive and convenient management solution.
VIZZ solves the need by offering a pharmaceutical alternative of demonstrated efficacy and safety. Clinical studies show that adults above the age of 50 lose 1.5 lines of near visual acuity every six years, emphasizes the requirements of efficient treatment like VIZZ. This product will be available in the US starting from October 2025. The new therapeutic option aims to enhance the quality of life by reviving the near vision instead of surgical method.
Clinical trials and approval
The FDA approval of VIZZ (aceclidine ophthalmic solution 1.44%) for the treatment of presbyopia was based on results from three randomized, double-masked, controlled Phase 3 clinical trials, including CLARITY 1 (NCT05656027), CLARITY 2 (NCT06045299), and CLARITY 3 (NCT05753189).
Across CLARITY 1 and CLARITY 2, a total of 466 participants aged 45 to 75 years with presbyopia were registered. Patients had a refractive range from -4.00 to +1.00 D sphere and astigmatism up to 2.00 D. These multicenter trials, including post-refractive surgery and pseudophakic patients, compared once-daily VIZZ dosing to controls over 42 days, focusing on both safety and efficacy.
Primary efficacy endpoints included the proportion of participants gaining three lines or more in high-contrast, distance-corrected near visual acuity at 40 cm—without losing a line or more of distance-corrected distance visual acuity. At three hours post-dose on Day 1, 65% of VIZZ patients in CLARITY 1 and 71% in CLARITY 2 achieved this improvement, compared to 12% and 8% of controls respectively, which was statistically significant.
The onset of improvement typically occurred within 30 minutes of dosing and lasted up to 10 hours. CLARITY 3 further evaluated 217 subjects for long-term safety over six months.
Safety analysis revealed the most common adverse reactions were instillation site irritation (20%), dim vision (16%), headache (13%), and mild to moderate eye redness. Most side effects were mild, transient, and resolved on their own. No serious treatment-related adverse events were observed during over 30,000 treatment days across trials.
Safety profile
VIZZ showed a favorable safety and tolerability profile in the Phase 3 CLARITY trials. The most common adverse events were mild and transient, including instillation site irritation (20%), dim vision (16%), headache (13%), and eye redness (~10%). No serious treatment-related adverse events or deaths were reported across more than 30,000 treatment-days. Overall, side effects were manageable and self-resolving, supporting its use as a daily therapy for presbyopia.
Statements from Key Opinion Leaders
Following the FDA approval of VIZZ™, LENZ Therapeutics leadership and clinical investigators highlighted both the clinical significance and patient impact of this milestone. Eef Schimmelpennink, President and Chief Executive Officer of LENZ, called the approval “a major step forward for the millions of Americans living with presbyopia,” noting that the Phase 3 CLARITY trials “consistently demonstrated rapid, meaningful, and sustained improvements in near vision with a well-tolerated safety profile.” He emphasized that VIZZ™ is the first and only FDA-approved aceclidine product, and said the company is proud to bring a daily, preservative-free option to patients seeking non-surgical treatment. Dr. Karolinne Rocha, one of the principal investigators for the CLARITY studies, described the clinical trial outcomes as “remarkable,” pointing to the rapid onset of action and the durability of the effect over the course of the day. She noted that most patients maintained clear distance vision while gaining functional near vision, which she believes will be “transformational in everyday life.” Together, their comments underscore the strength of the data and the potential for VIZZ™ to become a meaningful new option in the management of age-related near vision loss.
Future viewpoint
The FDA approval of VIZZ (aceclidine ophthalmic solution 1.44%) marks a significant advancement in the treatment of presbyopia, offering a convenient, non-invasive, once-daily eye drop alternative to traditional glasses or surgical options. This milestone underscores the importance of ongoing innovation in ophthalmology to address widespread vision problems and improve patient quality of life.
Future research will focus on exploring long-term benefits, optimizing dosing regimens, and expanding the use of VIZZ across diverse patient populations, including those with different types of presbyopia or ocular comorbidities. Ongoing and upcoming studies are expected to provide further insights into the sustained safety and efficacy of VIZZ.
As VIZZ becomes more widely available, its ease of use and favourable safety profile are likely to drive greater patient acceptance and adherence. This advancement in pharmacologic treatment holds promise to transform presbyopia management, enabling millions of patients to enjoy improved near vision and enhanced daily functionality without the limitations of corrective lenses or invasive procedures.
Reference
LENZ Therapeutics Announces US FDA Approval of VIZZ™ for the Treatment of Presbyopia https://ir.lenz-tx.com/news-events/press-releases/detail/39/lenz-therapeutics-announces-us-fda-approval-of-vizz-for-the-treatment-of-presbyopia
FDA Approve Presbyopia Treatment First VIZZ 1.44% is the first FDA-approved aceclidine-based eye drop for the treatment of presbyopia in adults https://theophthalmologist.com/issues/2025/articles/august/fda-approve-presbyopia-treatment-first/
VIZZ – A once-daily prescription eye drop to treat blurry near vision https://www.vizz.com/
Highlights of Prescribing Information These highlights do not include all the information needed to use VIZZ™ safely and effectively. See full prescribing information for VIZZ https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/218585s000lbl.pdf
Evaluation of the Efficacy and Safety of LNZ101 and LNZ100 for the Presbyopia https://www.clinicaltrials.gov/study/NCT06045299
Phase 3 Safety Study for the Treatment of Presbyopia Subjects https://clinicaltrials.gov/study/NCT05753189