LENZ Therapeutics Announces FDA Approval of LNZ100 (1.75% Aceclidine) Ophthalmic Solution for Presbyopia

7Month31Day,LENZ TherapeuticsAnnounce,FDAHas already been approvedLNZ100Eye Drops（1.75%AceclidineListed for the treatment ofPresbyopia(Presbyopia)。

LENZ TherapeuticsPartners in ChinaCORXELAs of7Month28Submitted the drug's marketing application in China. If approved smoothly, this medication will become the first eye drop in China to improve near vision for patients with presbyopia.

AboutLNZ100Eye Drops

LNZ100YesLENZ TherapeuticsDeveloped a preservative-free formulation for daily use.1Acclidine Acetate Eye Drops.Its chemical structureBelongs to small molecule acetylcholine receptor agonists,Its mechanism of action is through the activation of the iris sphincter muscleM3Receptor implementation, with higher compared to non-selective agonists such as pilocarpineM3Selective for muscarinic receptors. This selectivity allows aceclidine to constrict the pupil and produce a pinhole effect to improve near vision while reducing stimulation of the ciliary muscle, thereby avoiding changes in lens refraction and damage to distance vision.

2022Year4In the month, CORXEL1.1Hundreds of millions of dollars in upfront and potential milestone payments, fromLENZ TherapeuticsObtainedLNZ100Exclusive Rights in Greater China。

FDAThis approval is based on two keyⅢPhase Research（CLARIFY 1AndCLARIFY 2）Positive data.Both studies were multicenter, double-blind, randomized controlled trials, enrolling a total of698Example45-75Presbyopia Patients（CLARIFY 1：469Example:CLARIFY 2：229Example), the range of vision is-4.0D SETo+1.0D SE。CLARIFY 1Aimed to evaluateLNZ100、LNZ101(Acetylcholine+Brimonidine)Efficacy and Safety of Brimonidine Monotherapy for Presbyopia;CLARIFY 2Aimed to evaluateLNZ101、LNZ100Efficacy and safety of placebo treatment for presbyopia. The primary endpoint of the study was3Hours, Best Corrected Distance Visual Acuity（BCDVA）Near Vision Improvement ≥3OK（15A letter), and distant vision decline ≤1OK（5A letter)The proportion of patients.

The study results show:71%Patients in3Improvement in near vision within hours ≥3OK(Distance vision decrease ≤1Row)，30Takes effect quickly within minutes, and40%Patients with sustained efficacy10Hours; no serious adverse events were reported in terms of safety, with the most common being mild eye irritation. Its convenient once-daily dosing and mechanism of selectively activating the iris sphincter muscle are significantly superior to similar drugs.

In China, CORXEL2023Year8In the month, it received approval from the China National Medical Products Administration (NMPA) to commenceLNZ100Phase III Clinical Trial for the Treatment of Presbyopia（JX07001）, and all patient enrollment has been completed. The data will support local approval, which is expected2026Year of listing.

Market Prospects

LNZ100Eye Drops（1.75%AceclidineThe market prospect is extremely broad. From the perspective of the current market situation, the number of presbyopia patients worldwide is enormous, approximately18Million, and this number is still growing. China alone has over4Hundreds of millions of patients, and there are also in the United States1.28100 million, which forLNZ100Providing a huge potential user base. Traditionally, the treatment of presbyopia has mainly relied on reading glasses and surgery, with a notable gap in drug therapy.LNZ100As the world's first approved presbyopia drug, it successfully fills this gap and is of milestone significance.

In terms of the competitive landscape,LNZ100Demonstrates significant advantages. Its once-daily usage, compared toVuity(Twice Daily)AndQlosi(Twice Daily)Such as competing products, which have greatly improved patient compliance. Meanwhile, it has10Long-lasting efficacy over hours, covering most of the daytime eye-use periods.

LENZThe company is developing longer-acting formulations, such as a once-a-week version, which will further solidify its technological barriers. Meanwhile,LNZ100is also exploring the expansion of indications, such asLNZ101(Acridine/Brimonidine Combination)Combined use, or expansion into the field of adolescent myopia control, opens up new space for future growth.

In the long term, population aging is a driving factor that cannot be ignored, globally60The proportion of people above a certain age is continuously increasing, and the number of patients with presbyopia will continue to grow. The upgrade in consumption also drives the rising demand among middle- and high-income groups for convenient, non-invasive treatment solutions. Based on current market trends and technological advancements, it is projected that by2030Year,LNZ100Global sales may exceed10Billion USD, becoming a blockbuster drug in the ophthalmology field.

1.LENZ Therapeutics