Lenz Therapeutics Announces FDA Approval of Vizz for the Treatment of Presbyopia
Near vision improvements were demonstrated within 30 minutes and lasted up to 10 hours in clinical trials.
Objective:
To announce the FDA approval of Vizz (aceclidine ophthalmic solution) for treating presbyopia in adults.
Key Findings:
- Vizz improves near vision within 30 minutes and lasts up to 10 hours.
- The treatment contracts the iris sphincter muscle to create a pinhole effect, enhancing depth of focus without inducing a myopic shift.
- All primary and secondary endpoints for near vision improvement were met in trials.
Interpretation:
Vizz offers a new non-surgical option for adults with presbyopia, providing significant near vision improvements without inducing a myopic shift.
Limitations:
- Common adverse events included mild and transient symptoms such as instillation site irritation, dim vision, and headache.
- Long-term effects beyond 6 months were not evaluated in the trials.
Conclusion:
Vizz is expected to be available in the U.S. by mid-Q4 2025, providing a promising treatment option for presbyopia.