LENZ Therapeutics has announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for LNZ100, a pharmacological candidate for the treatment of presbyopia. The acceptance marks a significant step toward a potential new treatment option for individuals with age-related near vision loss.
The NDA submission is based on positive results from the pivotal Phase 3 CLARITY study. The CLARITY study met all primary and secondary endpoints, demonstrating a statistically significant improvement in near vision for participants treated with LNZ100. Specifically, participants achieved a 3-lines or greater improvement in Best Corrected Distance Visual Acuity at near and did not lose 1 line or more in distance visual acuity.
Presbyopia, a common age-related condition, affects the ability to focus on near objects, impacting a large portion of the adult population. Current treatment options include corrective lenses or surgery. LNZ100 represents a potential pharmacological alternative that could offer a less invasive approach to managing this condition.
