FDA Approves Presbyopia Treatment, VIZZ

LENZ Therapeutics, Inc. announced the FDA approval of VIZZ (aceclidine ophthalmic solution) 1.44% prescription eye drops for the treatment of presbyopia in adults, according to a news release. Commercial samples are expected to be available in the United States as early as October 2025, with full market availability anticipated by mid-fourth quarter 2025.

Presbyopia is characterized by the loss of near vision due to aging. It impacts nearly all individuals over the age of 45 and is caused by the gradual hardening of the eye’s crystalline lens. This hardening makes it more difficult for the lens to focus on objects up close. It is typically self-diagnosed, and treatments include bifocal glasses or multifocal contact lenses. On average, adults over 50 lose 1.5 lines of near vision every six years.

VIZZ is preservative-free. It is designed to contract the iris sphincter muscle, creating a pinhole effect that improves depth of focus and enhances near vision without inducing a myopic shift. It achieves a sub-2 mm pupil size and maintains efficacy for up to 10 hours after a single drop, according to clinical trial data.

“The FDA approval of VIZZ is a defining moment for LENZ and represents a transformative improvement in the available treatment options for the 128 million adults living with blurry near vision in the United States. 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,” Eef Schimmelpennink, president and CEO of LENZ Therapeutics, said in the news release. “This significant milestone is the result of tremendous commitment and collaboration by the LENZ team and our partners, the dedication of our clinical investigators, and the contributions of hundreds of participants in our clinical trials. I want to thank each of them for their role in getting VIZZ FDA approved.”

This approval is based on the results of three phase 3 studies. CLARITY 1 and CLARITY 2 evaluated the safety and efficacy of VIZZ in 466 patients who received one dose daily for 42 days. CLARITY 3 evaluated long-term safety in 217 patients who received VIZZ daily for six months. In all, more than 30,000 treatment days were observed.

Most adverse reactions were mild and self-resolving, the most common being instillation site irritation (20%), dim vision (16%) and headache (13%). Conjunctival hyperemia (8%) and ocular hyperemia (7%), both seen as eye redness, were also noted.

To use VIZZ correctly, patients should instill one drop in each eye, waiting 10 minutes before instilling a second drop, according to the prescribing information. Contact lenses should be removed before VIZZ application but may be reinserted ten minutes later.

If a patient’s doctor is ordering direct, VIZZ is available for $79 a month, which includes 25 doses, or $198 for three months, for 75 doses, according to their website. VIZZ pricing may vary depending on pharmacy location pickup.

“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,” Marc Bloomenstein, OD, FAAO, of Schwartz Laser Eye Care Center in Scottsdale, Arizona, who served as a clinical investigator, said in the news 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.”