FSYX Ocular Pressure Adjusting Pump

FSYX is an FDA‑cleared, prescription device that lowers eye pressure while you sleep. It consists of soft, airtight goggles linked to a small, quiet pump that creates gentle negative pressure around each eye. By slightly reducing the atmospheric weight pushing on the cornea, the device drops intra‑ocular pressure (IOP) by about 30‑40 % during overnight wear in early studies.12

The pump draws air out of the goggles until a preset negative‑pressure (NP) level is reached. Lower outside pressure lets the eye expand outward a fraction of a millimeter, easing fluid outflow and reducing IOP. Integrated sensors track NP and usage time, and data can be shared with your eye‑care team.

Standard protocols call for 6–8 hours of nightly wear at NP settings between –8 and –15 mm Hg. Custom schedules and re‑usable gel seals are available for sensitive skin.34

FSYX is cleared for adults with open‑angle or normal‑tension glaucoma whose IOP is ≤ 21 mm Hg on daytime testing but tends to creep up at night. It can be added to drops, laser, or surgery when further pressure reduction is needed.

• Ideal for patients with documented nocturnal or early‑morning pressure spikes
• Helpful when additional daytime medications cause side effects
• Not advised for active eye infection, recent surgery, or severe sleep apnea that prevents mask use

The device earned De Novo classification after multicenter trials showed consistent overnight IOP reduction without serious adverse events.56

Benefits
• Drug‑free, non‑invasive pressure control during vulnerable sleep hours.
• Adjustable and reversible—IOP returns to baseline when goggles are removed.
• Generates compliance reports for you and your doctor.

Limitations
• Must be worn nightly for sustained benefit.
• Mild facial marks or warmth may occur where the seal sits.
• Effect is temporary; daytime drops or other therapies usually remain.

AAO experts note that negative‑pressure goggles fill a gap for patients whose pressures are “borderline controlled” but who are reluctant to add more medications or another surgery.78

Reported side effects are generally mild and resolve after device removal. They include transient skin indentation, slight eye redness, and a feeling of pressure release when the goggles come off. No permanent vision loss or corneal damage has been linked to FSYX in peer‑reviewed studies so far.

Because the device minimally alters blood flow around the eye, people with fragile optic nerves still need regular check‑ups and imaging to be sure the optic nerve stays stable.910

No downtime is required. Your doctor will:

1. Record baseline IOP and optic‑nerve images.
2. Review device data after the first week to fine‑tune NP settings.
3. Check IOP every 3–6 months and adjust other treatments if the nighttime drop allows.

Long‑term studies suggest that combining FSYX with standard daytime therapy may slow disease progression more effectively than drops alone.1112

Researchers are exploring lower‑profile goggle designs, integration with home tonometers, and personalized NP algorithms based on optic‑nerve perfusion. Work is also under way to see whether negative pressure could protect eyes with very low daytime IOP by improving optic‑nerve blood flow.

Basic science from the National Eye Institute continues to shed light on how mechanical strain and low cerebro‑spinal‑fluid pressure may contribute to glaucoma, supporting technologies that balance these forces overnight.1314

If your pressures rise overnight or your optic nerve is still thinning, schedule a visit with a glaucoma specialist. They can review your pressure profile, demonstrate FSYX fitting, and decide how it fits with drops, laser, or surgery. You can connect with the right specialist through Kerbside and safeguard your sight for the long haul.

Bring recent pressure readings and a list of current medicines so the consultation is as productive as possible.1516