Corxel and Lenz Therapeutics Announce Positive Phase 3 Trial Results for Presbyopia Eye Drop LNZ100 in China
Lenz Therapeutics and its parner Corxel Pharmaceuticals unveiled phase 3 trial results from the China-based JX07001 study, showing that LNZ100, an aceclidine-based eye drop, achieved significant improvement in near vision for presbyopia patients. The study's topline results demonstrated LNZ100's rapid efficacy, long-lasting impact, and favorable safety profile, the companies announced in a dual news release.
The phase 3 clinical trial, a randomized, double-blind, vehicle-controlled study, assessed LNZ100’s efficacy and safety in 300 participants aged 45-75. The eye drop achieved the primary endpoint of enhancing near vision by 3 lines or more, with a significant proportion of patients maintaining their distance vision without losing five or more letters on the vision scale. LNZ100 showed rapid onset with 84% of patients gaining 2-line improvement and 69% gaining 3-line improvement within 30 minutes (P<0.0001). At 3 hours post-application, the efficacy was even higher, with 88% showing 2-line and 74% showing 3-line or greater improvements in near vision. The effect persisted for up to 10 hours in a notable proportion of participants.
“We are thrilled with the significant efficacy and safety demonstrated in the LNZ100 trial for patients with presbyopia, marking a major advancement in presbyopia treatment in China,” Professor Jia Qu, Principal Investigator and Vice Chairman of the Ophthalmology Branch, Chinese Medical Association, said in a company news release. “Most patients rely solely on eyeglasses, which are often inconvenient. LNZ100 presents an opportunity for noninvasive, reversible treatment that could meet a significant unmet need for presbyopia management in China.”
The phase 3 data in China comes 2 months after Lenz submitted a new drug application (NDA) to the FDA for LNZ100. The NDA submission follows the successful completion of the pivotal phase 3 CLARITY study, which met all primary and secondary endpoints, showing statistically significant improvements in near vision.
“Congratulations to the Corxel team on their successful phase 3 study,” said Eef Schimmelpennink, CEO of Lenz Therapeutics. “These results, alongside the recent FDA acceptance of our new drug application for LNZ100 in the US, advance our goal of delivering a comprehensive near-vision solution that could help address presbyopia for millions worldwide.”