LENZ Therapeutics has reported positive topline data from its Phase II INSIGHT clinical trial of two investigational aceclidine formulations for the treatment of presbyopia.
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.”