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# Lenz Therapeutics NDA Accepted for Farsightedness
- URL: https://www.fdaweb.com/lenz-therapeutics-nda-accepted-for-farsightedness/
- Published: 2024-10-21T12:00:00.000Z
- Updated: 2026-09-14T14:44:33.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158017

FDA has accepted for review a Lenz Therapeutics NDA for LNZ100 (aceclidine), an eyedrop medication for treating presbyopia (farsightedness). The agency set a user fee review action target date of 8/8/2025.

The submission is based on Phase 3 data from CLARITY 1 and 2 trials which showed that the drug (1.75% aceclidine) achieved the primary endpoints and key secondary endpoints, with statistically significant three-lines or greater improvement in best corrected distance visual acuity near vision test without losing one-line or more in distance visual acuity, according to the company. In the vehicle-controlled CLARITY 2 trial, data showed a rapid onset (71% achieved three lines or greater improvement at 30 minutes), and a long duration (40%) achieved three lines or greater improvement at 10 hours), it says.

Lenz adds that the drug was well-tolerated with no serious treatment-related adverse events observed in over 30,000 treatment days across all CLARITY trials.