Lenz presbyopia drop meets endpoints in near vision improvement in phase 3 trials
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Key takeaways:
- LNZ100, an aceclidine-based eye drop, demonstrated a rapid onset and long duration in phase 3 presbyopia trials.
- Lenz Therapeutics plans to submit a new drug application for LNZ100 later this year.
Patients with presbyopia achieved visual acuity improvement with LNZ100 in the phase 3 CLARITY safety and efficacy trials, according to a press release from Lenz Therapeutics.
The CLARITY 1 and 2 trials investigated the eye drops LNZ100 (1.75% aceclidine) and LNZ101, another formulation of aceclidine, for the treatment of presbyopia. The trials included 1,059 patients aged 45 to 75 years who had a spherical equivalent refractive range between –4 D and +1 D. CLARITY 1 was brimonidine controlled, while CLARITY 2 was vehicle controlled.
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The primary efficacy endpoint in both trials was the percentage of patients who achieved an improvement in best corrected distance visual acuity of three lines or more at near without losing one line at 3 hours after treatment.
LNZ100 achieved all primary and secondary near vision improvement endpoints. In the CLARITY 2 trial, day 1 results showed a rapid onset, with 71% of patients achieving at least three lines of improvement at 30 minutes. Additionally, 71% of patients achieved at least three lines of improvement at 3 hours, and 40% achieved three lines of improvement at 10 hours.
The near vision improvement was reproducible and consistent in both trials throughout the 4-week study period. In addition, LNZ100 was well tolerated with no reports of serious treatment-related adverse events.
LNZ101 showed similar results in the trials but did not show superiority to LNZ100, so Lenz Therapeutics selected LNZ100 as its lead product candidate.
“Based on these highly encouraging data, we will direct our focus towards our [new drug application] 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,” Eef Schimmelpennink, president and CEO of Lenz, said in the release.
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