Lenz Plans NDA for Presbyopia Eye Drops

Lenz Therapeutics says it will file an NDA for aceclidine eye drops in a few months after reporting Phase 3 study results for treating presbyopia, which affects near vision in people over 45. The data from CLARITY 1 and 2 trials showed that LNZ100 (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. 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), according to the company.

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