Lenz Therapeutics Submits NDA for LNZ100 Eye Drop for Presbyopia

Lenz Therapeutics has submitted a new drug application (NDA) to the FDA for LNZ100, an investigational presbyopia eye drop. This aceclidine-based ophthalmic solution is designed to improve near vision in people with presbyopia.

The NDA submission follows the successful completion of the pivotal phase 3 CLARITY study, which evaluated LNZ100 for presbyopia treatment. The study met all primary and secondary endpoints, showing statistically significant improvements in near vision. Specifically, LNZ100 achieved 3 lines or greater improvement in best corrected distance visual acuity (BCDVA) at near without compromising distance vision. The treatment was well tolerated, with no serious adverse events reported over the 30,000 treatment days monitored in the study, according to Lenz. 

"The submission of our NDA for LNZ100 is a significant milestone for Lenz and is a testament to the tremendous focus, execution, and collaboration of our team," Eef Schimmelpennink, President and CEO of Lenz Therapeutics, said in a company news release. "We believe LNZ100 has the potential to be best-in-class as a pupil-selective and long-acting therapeutic option for the treatment of presbyopia. We look forward to working alongside the FDA through this review process."

The FDA now has a 60-day review period to determine if the NDA submission is complete and acceptable for a full review. If approved, LNZ100 could become the first aceclidine-based eye drop available to treat presbyopia.

View EyewireTV's coverage of the NDA submission here.