Institute of Good Manufacturing Practices India®

(An Autonomous Body Recognized by Ministry of Commerce & Industry, Government of India)

LENZ declares positive results from presbyopia treatment trial

LENZ Therapeutics disclosed positive results from the Phase III CLARITY study assessing aceclidine formulations, LNZ100 and LNZ101, for presbyopia treatment.

The trial included two six-week efficacy trials, CLARITY 1 and 2, and a six-month safety trial, CLARITY 3, involving 1,059 participants aged 45 to 75 years.

Primary efficacy focused on the percentage of subjects achieving a three-line or greater improvement in Best Corrected Distance Visual Acuity (BCDVA) without losing more than one line of distance vision three hours post-treatment.

LNZ100 (1.75% aceclidine) met primary and key secondary endpoints in CLARITY 1 and 2. Notably, 71% showed BCDVA improvement at 30 minutes, with 40% maintaining it for ten hours post-treatment. Near vision enhancement was consistent.

LNZ100 demonstrated good tolerability, with no serious treatment-related adverse events reported. While LNZ101 met primary and secondary endpoints, it didn't surpass LNZ100. Consequently, LNZ100 is chosen as the lead candidate for an NDA submission in mid-2024.