Objective:

To announce the FDA 510(k) clearance of the FSYX Ocular Pressure Adjusting Pump (OPAP) for lowering intraocular pressure during sleep in adults with open-angle glaucoma.

Key Findings:

• The FSYX OPAP is the first device specifically designed for nocturnal IOP reduction.
• No serious device-related adverse events were reported in clinical studies.
• The device is intended to be used alongside existing glaucoma treatments.

Interpretation:

The OPAP addresses the issue of elevated IOP during nighttime when conventional therapies may be less effective.

Limitations:

• The device is prescription-only and will be available to eye care practices in Q4 2026.

Conclusion:

The FSYX OPAP represents a significant advancement in the management of glaucoma by targeting nighttime IOP.