Vizz Becomes First, Only FDA-Approved Aceclidine-Based Eye Drop for Presbyopia
The FDA approves aceclidine ophthalmic solution 1.44%, the first aceclidine eye drop for presbyopia, offering a new solution for millions struggling with near vision loss.
The FDA approved aceclidine ophthalmic solution 1.44% (Vizz; Lenz Therapeutics) for the treatment of presbyopia in adult patients. With this action, Vizz has become the first and only FDA-approved aceclidine-based eye drop for this condition, according to a news release.
Vizz is an aceclidine-based eye drop that differentiates itself from others with its mechanism of action. It is a predominantly pupil-selective miotic that interacts with the patient’s iris, with minimal ciliary muscle stimulation. The eye drop contracts the iris’s sphincter muscle, resulting in a pinhole effect that uniquely achieves a sub-2mm pupil that extends a patient’s depth of focus to significantly improve their near vision without resulting in a myopic shift.
Presbyopia is the inevitable loss of near vision associated with aging. It impacts the daily lives of nearly all people over the age of 45. The crystalline lens in individuals’ eyes gradually hardens and becomes less able to change shape as they age, and this loss of elasticity of the lens reduces its ability to focus incoming light from near objects onto the retina. Adults over age 50 lose about 1.5 lines of near vision every 6 years.
Although the progression of presbyopia is gradual, patients with the condition often experience an abrupt change in their daily life as the symptoms become more pronounced starting in their mid-40s, when reading glasses or other corrective aids are suddenly necessary to read text or conduct close-up work. Typically, presbyopia is self-diagnosed and self-managed with over-the-counter reading glasses or managed with prescription reading or bifocal glasses or multifocal contact lenses following evaluation by an eye care specialist.
“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,” clinical investigator Marc Bloomenstein, OD, FAAO, Schwartz Laser Eye Care Center in Scottsdale, Arizona, said in a 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, with a product profile that will meet our patients’ needs.
The approval was based on results from 3 randomized, double-masked, controlled phase 3 trials. Two of which, the CLARITY 1 and CLARITY 2 trials, met all primary and secondary near vision improvement end points. In these trials, the safety and efficacy of Vizz were evaluated in 466 participants who were dosed once per day for a 42-day duration. Vizz demonstrated its ability to improve near vision within 30 minutes and last up to 10 hours. Specifically, an April 2024 news release states that 71% of trial participants achieved 3-line or greater improvement at 30 minutes and 3 hours, and 40% continued to have these improvements at 10 hours.
Of note, Vizz was well-tolerated, with no serious treatment-related adverse events (AEs) observed over the 30,000 treatment days across all 3 CLARITY trials. The most common AEs observed were installation site irritation, dim vision, and headache, the majority of which were considered mild in severity, transient, and self-resolving.
“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.
