Ophthalmologist-founded Balance Ophthalmics has received FDA 510(k) clearance for a wireless-enabled variation of the FSYX Ocular Pressure Adjusting Pump (OPAP), an intraocular pressure (IOP)-lowering device for glaucoma patients.
First, talk about this clearance.
FDA 510(k) clearance is reserved for medical devices.
Wait, didn’t the FDA already grant the system clearance?
Not 510(k) clearance—a De Novo classification. See here for what this means.
More details can be found here in our 2024 coverage.
Now to the basics of FSYX OPAP.
The FSYX OPAP system is intended for use as a prescription-based, non-pharmacological, and non-surgical treatment for lowering IOP in normal-tension glaucoma (NTG) patients while they sleep.
- Notably: The device is reported to be first and only therapy of its kind to target nocturnal IOP reduction (see here for a look at why IOP levels increase at night).
Talk about its design.
The system consists of a pair of eye goggles (similar to swimming goggles, if you want a visual) and a programmable pressure-modulating pump.
- Each eyepiece is equipped with a tube to create and monitor negative pressure.
- This compact and portable pump consists of two mini diaphragm pumps.
Also: A USB cable and AC adaptor are also included, to charge the OPAP after each use.
And how does the system work?
As patients sleep, the goggles combine with the system’s two mini diaphragm pumps to apply gentle negative pressure (np) to the eyes to reduce IP.
- Each pump exerts up to -40 mmHg relative atmospheric pressure (limited to -20 mmHg) that, in turn, create np levels within each eye
The device continuously lowers IOP while in use; however, the reduction of IOP ends once the device turns off.
Click here for a downloadable FSYX patient education guide. More details can also be found here.
Can ECPs track this IOP reduction?
Absolutely. A patient’s prescribing eyecare provider (ECP) will receive the overnight data from the system to monitor IOP levels.
And how does it work with existing glaucoma therapies?
FSYX works alongside any current medications—as well as in patients with prior surgical interventions—as a supplemental therapy.
So does the wireless version of the FSYX OPAP operate any differently?
Nope. This updated system simply adds wireless communication to the device, allowing clinical practices access to the real-world, patient-usage data and further insights into at-home patient behavior.
Nice! Speaking of data … how has the device performed in clinical research?
FSYX has undergone evaluations across multiple clinical studies involving 600+ glaucomatous eyes.
Among the findings:
- 58.1% of study eyes demonstrated a ≥20% IOP reduction by Week 52 clinic visit.
- 63.4% of study eyes (3.2% of control eyes) demonstrated a ≥20% IOP reduction by Week 52 sleep lab visit.
And more recently?
Results from the prospective, multicenter, masked, randomized, fellow-eye controlled HERCULES trial concluded the device “safely and effectively lowers both daytime and nocturnal IOP in patients with NTG,” with:
- A 39% mean IOP reduction at Week 52
- No serious device-related adverse events (AEs)
- See here for ocular AEs observed in prior trials
Also, check out this page for a visual of the clinical findings.
And now to the big question: When will the wireless device be available?
The company expects to make the FSYX OPAP available for clinical practices later this year (Q4 2026).
To note: The device’s actual delivery to patients will be direct (to their homes).
Until then: Contact Balance with any outstanding questions—including the cost and potential insurance options for patients.