LENZ Therapeutics submits NDA for drops to treat presbyopia
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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 events reported in more than 30,000 treatment days in the study.
“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, the company’s president and CEO, said in the 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.”
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