LENZ Therapeutics' LNZ100 NDA Accepted by FDA for Presbyopia Treatment

Key Insights

• The FDA has accepted the New Drug Application (NDA) for LENZ Therapeutics' LNZ100, a potential treatment for presbyopia.
• The NDA is supported by Phase 3 CLARITY study data, which demonstrated significant near vision improvement in participants.
• Participants in the CLARITY study achieved at least a 3-line improvement in Best Corrected Distance Visual Acuity at near without losing distance visual acuity.

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.