The FDA has granted De Novo marketing classification to Balance Ophthalmic, Inc. for its FYSX Ocular Pressure Adjusting Pump (OPAP) system as an adjunct therapy to reduce intraocular pressure (IOP) among patients diagnosed with normal-tension glaucoma (NTG) and open-angle glaucoma (OAG).
Remind me—what’s this FDA designation?
Per the FDA: A De Novo classification is a “risk-based classification process” to provide a marketing pathway to classify novel medical devices that “provide reasonable assurance of safety and effectiveness for the intended use.”
- Key to this designation: There cannot already be a device legally marketed for the same intended use (referred to as a “predicate device.”)
Now this company.
Formed in 2023 and based in Sioux Falls, South Dakota, Balance Ophthalmics is a healthcare company launched by John Berdahl, MD, a board-certified ophthalmologist who currently serves as chair of Balance.
The company’s focus: developing glaucoma management solutions—which brings us to the FYSX OPAP system.
Give me the rundown on it.
Initially dubbed the “Mercury Multi-Pressure Dial System” when developed under the then-Equinox name,FYSX (pronounced “physics”) is designed as the first non-pharmacological, non-surgical, AND prescription-only therapy for lowering IOP in glaucoma patients.
Its indication: Reducing IOP at night (ie: during sleep) in adult NTG/OAG patients with an IOP ≤ 21 mmHg who are currently using or have undergone another IOP-lowering treatment.
Note: The device was previously submitted for a De Novo classification in 2021; however, the request was rejected due to “concerns regarding device effectiveness and safety.”
Thus: More clinical testing ensued (we’ll get to that in a moment).
How is it designed?
The FYSX system is equipped with:
- Eye goggles
- Separate tubes attached to each eyepiece to create/monitor negative pressure
- Programmable pressure-modulating pump
- Designed to be compact and portable
- Two mini diaphragm pumps for creating negative pressure levels in each eye
- Note: Each pump exerts up to -40 mmHg relative atmospheric pressure (limited to -20 mmHg)
Plus: Both goggles and pump are connected mechanically and pneumatically via a tubing system.
How does it work?
The system uses an alternative IOP parameter (developed by Balance) to measure IOP while the device is in use.
The pressure-sensing goggles are intended to be worn at night—when IOP is often the highest—and apply negative pressure (np).
- The result: The device not only lowers IOP while in use, but the reduction in IOP ends once the device turns off.
What kind of clinical data supports its use?
Over 20 studies, including the CONFIRM (CP-X19) pivotal study and the prospective, multicenter, evaluator-masked, 12-month Artemis study.
More about the CP-X19 study’s findings: Both the pre-specified primary and secondary endpoints were met, with:
- 58.1% of study eyes (1.1% of control eyes) demonstrating a ≥20% reduction of IOP by the Week 52 clinic visit
- 63.4% of study eyes (3.2% of control eyes) demonstrating a ≥20% reduction of IOP by the Week 52 sleep lab visit
However: Following use of the device, Goldmann applanation tonometry found that the IOP reverted “closely to the IOP measured before the device use.”
And the FDA’s feedback on that data?
During the FDA’s Ophthalmic Devices Panel of the Medical Devices Advisory Committee meeting in March 2024 regarding the FYSX OPAP, the following was concluded:
“The panel agreed that the data demonstrated a reasonable assurance of effectiveness as an adjunctive therapy for the indicated patient (ie: NTG/OAG) population.”
The stipulation: The panelists also noted that postmarked studies are needed to evaluate glaucoma progression, along with monitoring key parameters such as optical coherence tomography (OCT) and visual fields (VFs).
Any adverse events to know about?
Based on the CP-X19 study findings, ocular adverse events (AEs) most frequently reported included:
- Eyelid edema (11.8%)
- Dry eye signs and symptoms (5.4%)
- Conjunctival hyperemia (4.3%)
- Eye pain (3.2%)
- Eyelid erythema (2.2%)
Now this Artemis study—what were those findings?
Results from the 2021 trial found that the following was demonstrated among NTG participants over a 52-week period:
- 33.1% mean decrease in IOP from baseline during -10 mm of mercury of NP application
- 51.2% mean decrease in IOP from baseline during -20 mm of mercury of NP application
Plus, based on the company’s IOP parameters:
- 63.4% of study eyes (3.2% of control eyes) achieved an IOP reduction of 20% or more during device use during the Week 52 sleep lab visit
Sounds promising … so what’s the intent of this system?
The bigger picture: The FYSX OPAP provides “instant control” of a patient’s IOP while also giving clinicians data on the product’s usage—including if and when patients are using the therapy.
“This confirmation will clarify the relationship between efficacy and patient compliance, and has the potential to develop into truly personalized therapy,” stated CEO Steph Jensen.
How might this be a breakthrough for patients?
Jensen noted that the company is aware of the “critical need to establish reimbursement and insurance coverage” to ensure NTG/OAG patients—who already have limited treatment options—have access to the FYSX OPAP.
And according to Dr. Berdahl, the system “makes (NTG) much more treatable, even for patients already on other treatments.”
He added: “Clinicians now have a predictable way to manage IOP in their most challenging cases.”
So when can we expect this system to be available on the market?
The company reported it is currently preparing for commercialization and market access, “with initial activity expected to begin in late 2025.”