LENZ Therapeutics Submits NDA for LNZ100 Eye Drops to Treat Presbyopia with Rapid Onset and 10-Hour Duration

Aug 13, 2024 17:30 CST Updated 17:30

LENZ Therapeutics

Ophthalmic Drug Product Developer

August 12, 2024LENZ TherapeuticsSubmitted to the U.S. FDAAceclidine (aceclidine) Eye Drops Formula LNZ100New Drug Application (NDA) for the Treatment of Presbyopia.

Presbyopia is a common eye condition that affects approximately 1.8 billion people worldwide. LNZ100 aims to improve near vision in patients with presbyopia without affecting their distance vision, allowing for enhanced near vision after the use of eye drops.30 MinutesSignificant improvements achieved domestically, andThe efficacy can be maintained10 hours! Patients only need to put a few drops of eye drops in the morning, and their near vision will be improved throughout the day!

CLARITY is a Phase 3, multicenter, double-blind, randomized clinical study evaluating the efficacy and safety of LNZ100 and LNZ101 in treating presbyopia. It consists of two six-week efficacy trials, CLARITY 1 and CLARITY 2, and a six-month safety trial, CLARITY 3.

This new drug application is supported by the positive data of LNZ100 in the pivotal Phase 3 CLARITY study. The study results showed that LNZ100 performed excellently across all primary and secondary endpoints in improving near vision.Best corrected distance visual acuity (BCDVA) significantly improved by three lines or more, while distant vision did not show significant decline. This indicates that LNZ100 was well-tolerated, with no serious treatment-related adverse events observed during the CLARITY study, which spanned over 30,000 treatment days.

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

Reach the primary endpoint: 71% of patients achieved an improvement of three or more lines on the eye 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).

LNZ100 Achieves Primary Endpoint in Trial

LNZ100 was well-tolerated, with no serious treatment-related adverse events observed in the three CLARITY trials.In the CLARITY 1 and 2 trials, the incidence of ocular adverse events reported was >5%, including instillation site irritation (mild stinging upon instillation), visual disturbance (mostly mild dimness), and congestion (mild eye redness). All these reports were classified as mild. The overall incidence of vehicle-corrected headache in the CLARITY 1 and 2 trials was 7.6%, with the vast majority (89%) classified as mild.

LNZ100 is well-tolerated

LNZ100, developed by LENZ Therapeutics, uses aceclidine as its main component. Aceclidine is a small-molecule acetylcholine receptor agonist that induces pupil constriction, creating a pinhole effect to improve near vision. However, compared with other cholinergic receptor agonists, it acts more specifically on the iris muscles that control pupil size, reducing the contraction of the ciliary muscles while constricting the pupil. This minimizes changes in the lens's refractive power and avoids affecting the patient’s distance vision.

The U.S. FDA will take 60 days to review the completeness and acceptability of the NDA submission. If LNZ100 is approved,WillProviding convenient non-surgical treatment options for patients worldwide.

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