LENZ Therapeutics Reports Positive Phase 3 Results for Aceclidine Eye Drops in Presbyopia, NDA Submission Imminent

LENZ Therapeutics (LENZ.US) announced positive results from its Phase 3 clinical trial, CLARITY, for two formulations of aceclidine eye drops in the treatment of presbyopia. Both the LNZ100 and LNZ101 formulations met the primary endpoints of the trial.

It is reported that, without affecting the patient's distance vision, significant improvement in near vision can be achieved within 30 minutes after using the eye drops, and the effect can last for up to 10 hours! This means that as long as the patient applies a few drops in the morning, their near vision can be improved for almost the entire day! The analysis also showed that LNZ100 demonstrated superior advantages over LNZ101. Based on these positive results, LENZ Therapeutics plans to submit the New Drug Application (NDA) for LNZ100 by mid-2024.

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

Analysis shows that LNZ100 (1.75% aceclidine) met the primary endpoint and key secondary endpoints of the trial, demonstrating an improvement of more than 3 lines (15 letters) on the near vision chart without losing 1 line (5 letters) of distance vision.