LENZ Therapeutics Submits NDA for LNZ100 Presbyopia Treatment

LENZ Therapeutics has submitted a New Drug Application for LNZ100, an aceclidine-based ophthalmic solution, to the FDA for the treatment of presbyopia, a condition affecting 1.8 billion people globally and 128 million in the U.S. The submission is a significant milestone for LENZ, which believes LNZ100 could be the best-in-class therapeutic option for presbyopia.

The NDA submission is supported by positive data from the Phase 3 CLARITY study, showing LNZ100 achieved all primary and secondary near vision improvement endpoints with significant three-line or greater improvement in Best Corrected Distance Visual Acuity at near without losing one line or more in distance visual acuity.