Lenz Therapeutics NDA Accepted for Farsightedness

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.