▎WuXiEdited by Kant Content Team

LENZ Therapeutics today announced that it has submitted a New Drug Application (NDA) to the U.S. FDA for its aceclidine ophthalmic solution, LNZ100, for the treatment of presbyopia. Based on previously published results from the Phase 3 trial, the treatment does not compromise patients' distance vision.Patients' near vision can significantly improve within 30 minutes after using LNZ100 eye drops, and the effect can last for 10 hours!This means that patients only need to apply a few drops of eye drops in the morning, and their near vision can be improved for almost the entire day! It is estimated that there are approximately 1.8 billion presbyopia patients worldwide.

TheNDASubmitted and obtainedLNZ100The Key to Treating Presbyopia3PhaseCLARITYPositive data support from the study.CLARITYIs a treatment for presbyopia3A multi-center, double-blind, randomized efficacy and safety study. It consists of two six-week efficacy trials.CLARITY 1And2And a six-month safety trialCLARITY 3Composition.

The analysis shows,LNZ100（1.75% Acrivastine) Achieved the primary endpoint and key secondary endpoint of the trial, demonstrating an improvement of more than 3 lines (15 letters) on the near vision chart while not losing 1 line (5 letters) of distance vision.In the CLARITY 2 trial with solvent control, the results on Day 1 of the trial showed that LNZ100 demonstrated the following effects:

▲LNZ100 Achieves Primary Endpoint of the Trial(Image source: Reference [2])

• Fast-acting:71% of patients achieved an improvement of three lines or more on the eye chart within 30 minutes.（p<0.0001）。

• Reach the primary endpoint:71% of patients achieved an improvement of three lines or more on the vision chart within 3 hours.（p<0.0001）。

• Long Duration:40% of patients achieved an improvement of three lines or more on the vision chart within 10 hours.（p<0.0001）。

• During the four-week study period, the improvement in near vision demonstrated by patients in the CLARITY 1 and 2 trials was reproducible and consistent.

• LNZ100 was well-tolerated, with no serious treatment-related adverse events observed in the three CLARITY trials.

  
  

▲LNZ100 Demonstrates Good Tolerability(Image source: Reference [2])

LNZ100, developed by LENZ Therapeutics, uses Aceclidine as its main ingredient.Aceclidine is a small-molecule acetylcholine receptor agonist that induces pupil constriction, creating a pinhole effect to improve near vision. Compared with other cholinergic receptor agonists, it exhibits greater specificity in its action on the iris muscles that control pupil size. This specificity reduces ciliary muscle contraction while constricting the pupil, minimizing changes in lens refraction and thereby avoiding adverse effects on the patient's distance vision.

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References:

[1] LENZ Therapeutics Announces Submission of New Drug Application to U.S. Food and Drug Administration for LNZ100 for the Treatment of Presbyopia. Retrieved August 12, 2024 from https://www.globenewswire.com/news-release/2024/08/12/2928326/0/en/LENZ-Therapeutics-Announces-Submission-of-New-Drug-Application-to-U-S-Food-and-Drug-Administration-for-LNZ100-for-the-Treatment-of-Presbyopia.html

[2] Topline CLARITY Results. Retrieved April 3, 2024 https://d1io3yog0oux5.cloudfront.net/_1b75a0055e0f2e21ec4f05c07a9d694b/lenztx/db/2266/21446/presentation/Clarity+Topline+Presentation+Slides+04022024+final+locked.pdf

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