Aceclidine-Based Eye Drop Looks Promising for Presbyopia

Treatment with an aceclidine-based eye drop was found to improve near vision in patients with presbyopia, according to phase 3 data.

The CLARITY 1 (ClinicalTrials.gov Identifier: NCT05656027) and CLARITY 2 (ClinicalTrials.gov Identifier: NCT06045299) trials evaluated the efficacy and safety of LNZ100 (aceclidine 1.75% ophthalmic solution), a selective miotic, for the treatment of presbyopia in patients aged 45 to 75 years with a refractive range of -4.0D SE to +1.0D SE. The study included users who previously had LASIK surgery or an intraocular lens implant. 

The primary endpoint for both studies was the percentage of patients who achieved 3-lines or greater improvement in Best Corrected Distance Visual Acuity (BCDVA) at near without losing 1-line (5 letters or more of distance vision) at 3 hours post treatment.

Both trials met the primary and secondary near vision improvement endpoints (P <.0001).

In the brimonidine-controlled CLARITY 1 trial, 72% of participants treated with LNZ100 achieved 3 lines or greater improvement at 30 minutes. At 3 hours and 10 hours, 64% and 27%% of participants achieved 3-lines or greater improvement, respectively.

In the vehicle-controlled CLARITY 2 trial, 71% of LNZ100-treated patients achieved 3-lines or greater improvement at 30 minutes. At 3 hours and 10 hours, 71% and 40% of participants achieved 3-lines or greater improvement, respectively. Additionally, 95% of patients achieved 2-lines or greater improvement at 1 hour post treatment (P <.0001). 

Treatment with LNZ100 was also associated with a statistically significant improvement of 2–4 letters on distance vision in normal light and no negative impact to distance vision in low light at all time points (P <.0001). 

“We believe these data support LNZ100 as a potential best-in-class therapy for the treatment of presbyopia,” said Eef Schimmelpennink, President and Chief Executive Officer of LENZ Therapeutics. “The high responder rate, rapid onset and long duration across a broad range of presbyopes ranging from 45 to 75 years of age and having a refractive range from -4.0 to +1.0D SE are consistent with features that patients are expecting from an effective treatment option. Based on these highly encouraging data, we will direct our focus towards our NDA submission in mid-2024 for LNZ100, and preparations for commercialization in second half of 2025 upon FDA approval, with the goal of moving closer to helping many of the 128 million people experiencing symptoms of presbyopia in the United States.”