Presbyopia, also known as tired sight, is the gradual loss of the eye’s ability to focus incoming light from near objects onto the retina.
MEXICO CITY (apro).- The U.S. Food and Drug Administration (FDA) has approved Vizz, an ophthalmic solution aimed at enhancing vision for adults suffering from presbyopia.
Presbyopia, commonly referred to as tired sight, involves a gradual decline in the eye’s capacity to focus light from close objects directly onto the retina—a membrane inside the eye that captures images and sends them to the brain via the optic nerve. This condition typically emerges around the age of 40 as part of the aging process, and is caused by the hardening of the lens inside the eye.
Produced by ophthalmic pharmaceutical company Lenz Therapeutics, Vizz is the first and only eye drop formulated with 1.44% aceclidine authorized by the FDA to improve near vision in adults with presbyopia.
“The FDA’s approval of Vizz marks a pivotal moment for Lenz and signifies a transformative enhancement in treatment options available for the 128 million adults experiencing near vision blur in the United States. We are eager and excited to launch the market’s first and only daily-use eye drop proven to work up to 10 hours,” said Eef Schimmelpennink, President and CEO of Lenz Therapeutics.
How does Vizz work?
The 1.44% aceclidine ophthalmic solution works by contracting the iris sphincter muscle, the colored part of the eye. This creates a pinhole effect, akin to viewing an object through a small aperture, resulting in a pupil size of less than 2 millimeters, which enhances the depth of focus of the eyeballs for near distances, without inducing a myopic shift—a condition where the eyes of a myopic person turn inward.
Vizz is administered once daily, providing up to 10 hours of improved sharp near vision, thanks to aceclidine being the sole active ingredient.
How was the new drug tested?
According to Lenz Therapeutics, the FDA’s approval of Vizz was based on the results from three randomized, double-blind, controlled Phase 3 studies.
Two of these were Clarity 1 and Clarity 2, in which the safety and efficacy of Vizz were assessed across 466 participants who received daily doses for 42 days, while Clarity 3 evaluated the long-term safety of the eye drop in 217 participants over a six-month period with daily application.
The studies showed improvements in near vision starting from 30 minutes and lasting up to 10 hours in some participants, both in primary and secondary measures.
Although adverse reactions were reported, the most common were irritation at the site of application, blurry vision, and headache. However, “most were mild, transient, and resolved on their own,” according to Lenz Therapeutics.
Samples of Vizz, as well as its availability for purchase in the United States, are expected to be available starting from October of this year.
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