In phase 3 trials of the first aceclidine-based presbyopia eye drop, 71% of patients achieved three-lines or greater improvement at 30 minutes, which was sustained for three hours, reported developer Lenz Therapeutics. Further, at 10 hours, 40% of the 1,059 participants enrolled in the two Clarity trials still had three-lines or greater improvement, it said. LNZ100 (1.75% aceclidine) also demonstrated statistically significant (p<0.0001) improvement of 2-4 letters on distance vision in normal light and no negative impact in low light at all time points. Overall, the drop achieved its endpoints, with statistically significant three-lines or greater improvement in best corrected distance visual acuity at near, without losing one or more lines in distance, said the company.
“The high responder rate, rapid onset and long duration across a broad range of presbyopes ranging from 45 to 75 years of age, with a refractive range from -4.0 to +1.0D SE, are consistent with features that patients are expecting from an effective treatment option,” said Eef Schimmelpennink, Lenz Therapeutics’ president and CEO.
The company plans to make a New Drug Application submission to the FDA in mid-2024, with a view to commercialisation in the second half of 2025.
