The US Food and Drug Administration (FDA) has given its first approval to an aceclidine-based eye drop for the treatment of presbyopia in adults.
Maker Lenz Therapeutics said it is ready and excited to launch Vizz aceclidine ophthalmic solution 1.44%, “the first and only once-daily eye drop with proven efficacy for up to 10 hours”.
Aceclidine, Vizz’s sole active ingredient, is a new chemical entity in the US and its FDA approval marks a “global first” in the treatment of presbyopia, said the company. The predominantly pupil-selective miotic interacts with the iris, with minimal ciliary muscle stimulation, said Lenz Therapeutics. “Vizz contracts the iris sphincter muscle resulting in a pinhole effect and uniquely achieves a sub-2mm pupil that extends depth of focus to significantly improve near vision without causing a myopic shift.”
The FDA approval is based on results from three randomised, double-masked, controlled phase 3 studies. Clarity 1 and 2 were designed to evaluate the safety and efficacy of Vizz in 466 participants dosed once daily for 42 days, while Clarity 3 evaluated its long-term safety in 217 participants over six months.
In both Clarity 1 and 2, Vizz achieved all primary and secondary near-vision improvement endpoints, demonstrating the ability to improve near vision within 30 minutes and last up to 10 hours. The drop was well-tolerated with no serious treatment-related adverse events observed in more than 30,000 treatment days across all three trials. The most common reported adverse reactions were instillation-site irritation, dim vision and headache. The majority of adverse reactions were mild, transient and self-resolving, Lenz Therapeutics said.
