LENZ Therapeutics has submitted a new drug application to the FDA for LNZ100, a preservative-free, once-daily aceclidine-based ophthalmic solution designed to treat presbyopia, the company announced in a press release.
According to the release, the submission is backed by positive data from the phase 3 CLARITY study, in which LNZ100 achieved all primary and secondary near-vision endpoints by significantly improving best-corrected distance visual acuity at near, without losing one line or more in distance acuity. In addition, LNZ100 was well-tolerated, with no serious treatment-related adverse