Home Cardiology FDA Approves Lenz Therapeutics’ Vizz™ for Presbyopia Treatment

FDA Approves Lenz Therapeutics’ Vizz™ for Presbyopia Treatment

by Team SunilMadhavs World
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Key Details:  

– Drug: Vizz™ (aceclidine ophthalmic solution 1.44%)  

– Indication: Treatment of presbyopia in adults.  

– Availability: Expected Q4 2024 (samples in October).  

Mechanism of Action  

Vizz is a once-daily eye drop that:  

1. Contracts the iris sphincter muscle to create a pinhole effect.  

2. Extends depth of focus to improve near vision.  

3. Avoids myopic shift (unlike some corrective lenses).  

Clinical Validation: Phase 3 CLARITY Trials  

| Trial | Participants | Duration | Key Outcomes |  

| CLARITY 1 | 466 adults | 42 days |

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✅ Met all primary/secondary endpoints<br>✅ Near vision improvement within 30 mins<br>✅ Effects lasted ≤10 hours |  

| CLARITY 2 | 466 adults | 42 days |

✅ Identical efficacy to CLARITY 1 |  

| CLARITY 3 | 217 adults | 6 months |

✅ Strong long-term safety profile<br>⛔ No serious treatment-related adverse events |  

Commercial & Patient Impact  

– Patient Benefits:  

  – Reduces dependency on reading glasses.  

  – Provides “visual freedom” for active lifestyles (≤10 hours).  

– Target Users:  

  – Contact lens wearers seeking glasses-free near vision.  

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  – Post-refractive surgery patients.  

  – Active individuals prioritizing discreet correction.  

– Professional Value:  

  – Offers eye care providers a complementary treatment option to existing solutions.  

Executive Insight  

> Eef Schimmelpennink (CEO, Lenz Therapeutics):  

> “Vizz delivers a convenient, transformative solution that lets presbyopes stay in the moment. It addresses unmet needs across diverse patient segments seeking independence from readers.”  

Key Takeaways  

1. FDA approval grounded in robust Phase 3 data (safety + efficacy).  

2. Rapid action: Near vision improvement in 30 minutes.  

3. Sustained effect: Up to 10 hours per dose.  

4. Expanded presbyopia management: Non-invasive alternative to glasses/surgery.

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