The formulations analysed in the trial are LNZ100 (aceclidine) and LNZ101 (aceclidine plus brimonidine).
The double-masked, multicentre, crossover, randomised, active and vehicle-controlled, safety and efficacy study enrolled 67 subjects aged 46-73 years.
These participants had a refractive error ranging from -3.25D SE to +1.5D SE. Some of them had undergone vision correction previously or were pseudophakic.
According to the findings, LNZ100 and LNZ101 met the primary endpoint of three-line or greater rise in near visual acuity without losing one-line or more in distance visual acuity at one hour.
Approximately one hour after treatment, the responder rates were 71%, 56% and 6% for LNZ100, LNZ101 and vehicle, respectively.
For all time points, including the latest evaluated at ten hours, LNZ100 and LNZ101 were found to offer statistically significant three-line or greater improvement of 37% and 48%, respectively, versus vehicle.
Additionally, the formulations preserved an average pupil size of 1.5-2mm for ten hours, which is an efficacy biomarker.
LNZ100 and LNZ101 were also observed to be well-tolerated without serious drug-associated adverse events.
Based on these data, the company intends to commence Phase III trials soon.
A small molecule acetylcholine receptor agonist, aceclidine causes contraction of the pupil called miosis, creating a pinhole effect to boost near vision.
LENZ Therapeutics president and CEO Eef Schimmelpennink said: “We know that the majority of presbyopia patients are looking for a product that is highly effective in improving near vision for their full workday.
“Our best-in-class results clearly reflect this ideal profile, with ten-hour efficacy, and further extend our potential for category leadership.”