On Thursday, the U.S. Food and Drug Administration approved LENZ Therapeutics, Inc.’s (NASDAQ:LENZ) VIZZ (aceclidine ophthalmic solution, previously known as LNZ100) 1.44%, the first and only FDA-approved aceclidine-based eye drop for presbyopia in adults.
Presbyopia is an age-related vision condition where the eyes gradually lose the ability to focus on nearby objects.
Samples are anticipated in the U.S. as early as October 2025, with the commercial product to be broadly available by mid of the fourth quarter of 2025.
Direct-to-eye care professional sales and marketing activities to be initiated immediately.
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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. Aceclidine, the sole active ingredient in VIZZ, is a new chemical entity in the U.S., and its FDA approval marks a global first in the treatment of presbyopia.
VIZZ is the first and only aceclidine-based eye drop approved to improve near vision in adults with presbyopia, a condition impacting approximately 128 million adults in the U.S. It is the first once-daily solution to treat blurry near vision with proven efficacy for up to 10 hours.
The FDA approval of VIZZ was based on results from three Phase 3 studies.
CLARITY 1 and CLARITY 2 were designed to evaluate the safety and efficacy of VIZZ in 466 participants who received a single daily dose for 42 days. CLARITY 3 evaluated 217 participants for long-term safety over 6 months of once-daily dosing.
In CLARITY 1 and CLARITY 2, VIZZ achieved all primary and secondary near-vision improvement endpoints, demonstrating the ability to improve near vision within 30 minutes and maintain the improvement for up to 10 hours.
Near vision improvement was reproducible and consistent across both CLARITY 1 and 2.
VIZZ was well-tolerated with no serious treatment-related adverse events observed in over 30,000 treatment days across all three CLARITY trials.
The most commonly reported adverse reactions by participants were installation site irritation, dim vision, and headache. The majority of adverse reactions were mild, transient, and resolved on their own.
In May 2025, the company announced an exclusive license and commercialization agreement granting Lotus Pharmaceutical rights to commercialize LNZ100 for presbyopia in the Republic of Korea and certain Southeast Asian countries.
Under the terms of the agreement, LENZ is eligible to receive up to $125 million in upfront, regulatory and commercial milestone payments, as well as tiered, double-digit royalties on net sales.
In July 2025, the company announced an exclusive license and commercialization agreement, granting Laboratoires Théa the rights to register and commercialize LNZ100 for the treatment of presbyopia in Canada.
LENZ will be eligible to receive over $70 million in upfront, regulatory, and commercial milestone payments and tiered, double-digit royalties on net sales.
Cash, cash equivalents, and marketable securities totaled $209.6 million as of June 30, 2025, which is anticipated to fund operations and generate positive cash flow post-launch.
Price Action: LENZ stock was up 0.86% at $30.03 at the last check on Friday.
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