Clinical Scorecard: Spotlight: Innovative Device Targets Eye Pressure Without Surgery or Meds

At a Glance

Key Highlights

• First FDA-approved nonpharmacological, nonsurgical glaucoma treatment.
• Achieved a mean IOP lowering of 39% in patients with IOP <21 mmHg.
• Device creates a microenvironment of negative pressure above the eye.
• Allows personalized therapy based on patient usage data.
• Minimal discomfort reported during clinical trials.

Guideline-Based Recommendations

Diagnosis

• Assess IOP levels in patients with open-angle glaucoma.

Management

• Consider FYSX for patients with IOP of 21 mmHg or less who are currently using or have undergone other IOP-lowering treatments.

Monitoring & Follow-up

• Monitor patient adherence and IOP levels to adjust treatment as necessary.

Risks

• Potential discomfort while wearing the device during sleep.

Patient & Prescribing Data

Adults with open-angle glaucoma and low or normal IOP.

FYSX may help stabilize glaucoma and avoid invasive procedures.

Clinical Best Practices

• Educate patients on the use and benefits of the FYSX device.
• Regularly assess IOP and adjust vacuum levels based on individual patient needs.
• Encourage patients to report any discomfort or issues with device usage.

References

• Ophthalmic Devices Panel of the Medical Devices Advisory Committee Meeting
• Evaluation of the IOP-lowering effect of a multi-pressure dial
• Negative pressure application to lower IOP in patients with glaucoma