LENZ Therapeutics, Inc.

While the large presbyopia space lacks a successful drug launch story, William Blair analysts argued that Vizz holds blockbuster potential given its differentiated efficacy and durability. Lenz Therapeutics has earned the FDA’s go-ahead for its aceclidine eye drop to crack the large presbyopia market, where past efforts by other drug developers have mostly been unsuccessful.The aceclidine 1.44% solution is now cleared under the brand name Vizz to treat adults with presbyopia, a form of farsightedness that’s commonly known as age-related blurry near vision, Lenz said Thursday.While broader commercial supply will not be ready until around November, the company expects to offer samples of the drug as early as October.Despite the outright failure or lackluster performance of past presbyopia drugs, such as AbbVie’s Vuity, analysts at William Blair and Citi argued that Vizz’s best-in-class profile may afford it a better chance at a successful rollout.Lenz has touted aceclidine’s novel mechanism of action as a pupil-selective miotic that predominantly interacts with the iris versus the ciliary muscle. By contracting the iris sphincter muscle, the drug may produce a sub-2mm pupil that extends the depth of focus to improve near vision without disrupting a person’s distance vision.Two phase 3 trials of Vizz, dubbed Clarity 1 and 2, met all primary and secondary near vision improvement endpoints, showing the drug can improve near vision within 30 minutes and last up to 10 hours. The FDA label for Vizz does include a warning about the risk of retinal tear or detachment. But William Blair analysts described the labeling as expected, given that those potential outcomes are a known risk for all miotics and no cases have been observed specifically with Vizz so far. Therefore, the team suggested that this issue won’t impact adoption.One potential surprise, however, is that while Lenz has labeled Vizz a once-daily solution, the drug is actually recommended to be given in two drops per eye two minutes apart. Nevertheless, the William Blair team again argued that this is a minor distinction for Vizz’s commercial profile.Presbyopia represents a “large, untapped” market, William Blair noted. AbbVie’s Vuity became the first FDA-approved eye drop to treat the condition in 2021. But as of 2025's second quarter, the drug didn’t have a separate line in AbbVie’s revenue report.Vuity has some safety issues, such as blurred vision and headache, which, although mild for most people, can be disruptive to the point of affecting patient adherence. Further, even after an additional FDA nod for a twice-daily dosing option, the drug’s effect can last just up to nine hours, shorter than Vizz’s 10-hour maximum through once-daily administration. “[W]e believe Vizz’s differentiated efficacy and durability positions it well for success,” the William Blair team wrote in a Thursday note, adding that it believes the drug holds blockbuster sales potential.“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,” Lenz CEO Eef Schimmelpennink said in a statement Thursday.To prepare for Vizz’s commercialization, Lenz has hired an 88-member sales force, the company disclosed in its second-quarter report Wednesday.

LENZ Therapeutics on Thursday said it secured FDA approval for Vizz (aceclidine ophthalmic solution), marking the first aceclidine-based eye drop authorised to treat presbyopia in adults, with the product slated to hit the shelves in the fourth quarter.Eef Schimmelpennink, chief executive of LENZ, said the availability of Vizz — intended for once daily administration — boosts “treatment options for the 128 million adults living with blurry near vision” in the country.The approval was supported by three late-stage studies — the pivotal brimonidine-controlled CLARITY 1 and vehicle-controlled CLARITY 2 trials assessing the eye drop’s safety and efficacy with once-daily dosing over 42 days, and CLARITY 3 evaluating long-term safety over six months.Results showed that Vizz (previously known as LNZ100) met all primary and secondary near vision improvement endpoints in both pivotal studies, demonstrating rapid onset within 30 minutes and sustained efficacy lasting up to 10 hours, alongside reproducible and consistent near vision improvement. Meanwhile, Vizz was well-tolerated, with no serious treatment-related adverse events reported over 30,000+ treatment days across all three CLARITY trials.LENZ also investigated another candidate LNZ101 — a combination of aceclidine and brimonidine — which failed to show superiority to Vizz despite meeting all endpoints in CLARITY 1 and 2, prompting the company to drop the former.Nipping at Vizz’s heels is Tenpoint Therapeutics’ Visus-derived Brimochol PF, a fixed-dose combination of carbachol and brimonidine tartrate, which demonstrated upbeat findings in a pair of Phase III presbyopia studies — BRIO-I and BRIO-II. Tenpoint recently filed a marketing application with the FDA and hopes for a product launch in the first half of next year.

July 28, 2025 -- LENZ Therapeutics, Inc. (Nasdaq: LENZ, “LENZ” or the “Company”), a pre-commercial stage biopharmaceutical company focused on the development and commercialization of the first and only aceclidine-based eye drop to improve near vision in people with presbyopia, today announced that CORXEL Pharmaceuticals (“CORXEL”) has submitted the New Drug Application (NDA) for LNZ100 to the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of the People’s Republic of China (PRC). LENZ licensed the Greater China rights to CORXEL for the development and commercialization of LNZ100 in April 2022. The NDA submission was supported by positive data from the Phase 3 JX07001 clinical trial of LNZ100 in patients with presbyopia in China. In this Phase 3 safety and efficacy trial, LNZ100 (1.75% aceclidine HCl) achieved the primary endpoint and secondary endpoints, with statistically significant three-lines or greater improvement in Best Corrected Distance Visual Acuity (BCDVA) at near, without losing one-line or more in distance visual acuity. The submission of the NDA for LNZ100 results in the achievement of the first milestone under the License and Collaboration Agreement with CORXEL (the “License”). Under the terms of the License, LENZ is eligible to receive up to $95.0 million of regulatory and sales milestones, as well as tiered mid single-digit to low double-digit royalties on net sales in Greater China. “This exciting milestone in our development partnership with CORXEL has come as a result of tremendous collaboration between the teams,” said Eef Schimmelpennink, President and Chief Executive Officer of LENZ Therapeutics. “This submission was supported by the impressive data generated from the Phase 3 clinical trial of LNZ100 in China, consistent with the data from the CLARITY trial. This is the first regulatory submission outside of the United States, further reinforcing the opportunity for LNZ100 to become a global therapy for the treatment of presbyopia.” LENZ Therapeutics is a pre-commercial biopharmaceutical company focused on the development and commercialization of the first and only aceclidine-based eye drop to improve near vision in patients with presbyopia. LENZ’s product candidate LNZ100 is a preservative-free, single-use, once-daily eye drop containing aceclidine. LNZ100 was evaluated in the registration-enabling Phase 3 CLARITY study as a potential therapy for the treatment of presbyopia, a condition impacting an estimated 1.8 billion people globally and 128 million people in the United States. The U.S. Food and Drug Administration (FDA) has assigned a Prescription Drug User Fee Act (PDUFA) target action date of August 8, 2025 for LNZ100. LENZ is committed to commercializing an ideal pharmaceutical presbyopia solution that enhances vision for “all eyes, all day”. LENZ is headquartered in San Diego, California. The content above comes from the network. if any infringement, please contact us to modify.