LENZ Therapeutics, Inc., a late clinical-stage biopharmaceutical company, submitted a New Drug Application (NDA) to the FDA for LNZ100, an aceclidine-based ophthalmic solution intended to treat presbyopia.

The submission is backed by positive results from the Phase 3 CLARITY study. In the study, LNZ100 met all primary and secondary endpoints, with statistically significant three-lines or greater improvement in best corrected distance visual acuity at near, without losing one line or more in distance visual acuity. The treatment was well tolerated with no serious adverse events reported.

The FDA has has a 60-day filing review period to determine whether the NDA submission is complete and acceptable for review.