Closely-held LENZ Therapeutics reported positive topline results from its Phase 2 INSIGHT clinical trial of two investigational formulations of aceclidine to treat presbyopia, or farsightedness.
Both LNZ100 (aceclidine) and LNZ101 (aceclidine + brimonidine) achieved the primary endpoint of three-line or greater improvement in near visual acuity, without losing one-line or more in distance visual acuity at one hour, with a responder rate of 71% for LNZ100 and 56% for LNZ101, compared with 6% of vehicle-treated.
Both LNZ100 and LNZ101 maintained statistical significance of three-line or greater improvement, compared with vehicle for all timepoints, including the last measured at 10 hours, with a responder rate of 37% for LNZ100 and 48% for LNZ101.
Both formulations maintained an average pupil size of 1.5mm to 2mm for 10 hours, which is a biomarker of efficacy.
In addition, patient feedback indicated both formulations were well-tolerated and there were no serious drug related adverse events. Based on these positive outcomes, the company plans to initiate Phase 3 trials shortly.
In a statement, Eef Schimmelpennink, president and CEO of LENZ, said 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 10-hour efficacy, and further extends our potential for category leadership,” he added.
The INSIGHT trial was a multicenter, double-masked, randomized, crossover, active and vehicle-controlled, safety and efficacy study with a broad study population of 46-to-73 years of age and refractive error -3.25D SE to +1.5D SE.
The trial enrolled 67 subjects, including some patients who had prior vision correction or were pseudophakic. Full results from the INSIGHT trial will be presented at future medical meetings.
In addition to achieving their primary endpoint, LNZ100 and LNZ101 both achieved the key secondary endpoint of two-line (10 letters) or greater improvement in near-visual acuity without losing one-line (5 letters) or more of distance vision, with a responder rate of 86% for LNZ100 and 78% for LNZ101 at one hour post treatment, and 55% and 58%, respectively, at 10 hours post treatment.
Both formulations also demonstrated rapid onset with 73% and 62% three-line or greater improvement within 30 minutes for LNZ100 and LNZ101 respectively, compared with 8% for vehicle.