Balance Ophthalmics’s FYSX Ocular Pressure Adjusting Pump is the first nonpharmaceutical and nonsurgical way to lower intraocular pressure (IOP) in people with low or normal eye pressure who have glaucoma.
“These patients have historically been challenging to treat because there are few medications or procedures that can effectively lower pressure when baselines are in the mid-teens,” says Seph Jensen, chief executive officer of Balance Ophthalmics in Sioux Falls, South Dakota. “Because FYSX works based on physics, not physiology, it works equally well regardless of a patient’s baseline IOP.” In fact, 1 study showed that FYSX achieved a mean IOP lowering of 39%, which was performed in patients whose IOP was <21 mmHg.1
Figure 1. The FYSX device includes 2 programmable pumps that create negative pressure (NP) within rubber-sealed goggles. There is a separate pump and tubing for each eye, allowing independent NP treatments as needed. Image courtesy Balance Ophthalmics.
How It Works
The FSYX pump produces a vacuum inside a pair of pressure-sensitive goggles that a patient wears when sleeping, thereby creating a microenvironment of negative pressure directly above the eye. “It’s like gently lifting a small amount of atmospheric pressure off the eye; when the pressure pushing down on the outside of the eye is reduced, the pressure inside the eye is also reduced,” Jensen says.
FYSX has a feature that allows physicians to know when patients use the pump, allowing for personalized therapy. “By understanding the amount of time and vacuum level that a patient receives during treatment, a provider can establish a new baseline of disease,” says Brian Shafer, MD, a cataract, refractive, cornea, and glaucoma surgeon at Shafer Vision Institute in Plymouth Meeting, Pennsylvania, who conducted research using the device. “If disease progresses, a provider can increase the vacuum or amount of time that the goggles are in place to further lower IOP.”
By wearing the device when sleeping, patients can experience consistent IOP lowering tailored to their specific needs, Jensen says. The device flattens their 24-hour diurnal curve by reducing or avoiding nocturnal IOP elevations.
Although some patients express concerns about their ability to get a restful night’s sleep while wearing the goggles, most of Dr. Shafer’s patients have rapidly adapted to the device, he says. Furthermore, during clinical trials, patients who used the device reported minimal discomfort and disruption during sleep.2,3
Clinical Applications
The US Food and Drug Administration has approved the FSYX system for adult patients with open-angle glaucoma who have IOP of 21 mmHg or less who are currently using or have undergone another IOP-lowering treatment, because the pump has only been studied in this cohort.
Jensen believes FYSX can benefit patients who are both early and advanced in their glaucoma journey. “If a patient is faced with a filtering procedure, such as a trabeculectomy or glaucoma filtering surgical procedures that use tubes, FYSX may represent an attractive alternative to try and slow or stop their visual field progression,” he says. “Equally, however, we believe FYSX is an excellent option for patients early in their disease who hope to stabilize their glaucoma and avoid invasive procedures altogether.”
“We’re excited about continuing our studies in a postmarketing environment and learning more about where our technology can continue to benefit patients,” Jensen says. “For now, we believe it’s important that patients also have other therapy options to manage their daytime IOP.”
Final Thoughts
The only treatments that have been proven to effectively lower IOP for normal-tension glaucoma patients are primarily filtering procedures, such as a trabeculectomy or glaucoma filtering surgical procedures that use tubes, Jensen says. These procedures are widely recognized to have inconsistent outcomes and poor safety profiles.
When using FYSX, however, studies have shown that every patient at every measurement experienced some level of IOP lowering across literally thousands of measurements.2,3
“For the first time, we can instantaneously lower a patient’s IOP in a titratable and reversible fashion using physics rather than relying on biology,” Dr. Shafer concludes. “We’re able to eliminate the variability of a tissue’s response to both drops and surgery.” GP
References
1. Ophthalmic Devices Panel of the Medical Devices Advisory Committee Meeting. March 21, 2024. Accessed December 18, 2024. https://www.youtube.com/watch?v=-MtrgURZTFs
2. Swan RJ, Ferguson TJ, Shah M, et al. Evaluation of the IOP-lowering effect of a multi-pressure dial at different negative pressure settings. Transl Vis Sci Technol. 2020;9(12):19. doi:10.1167/tvst.9.12.19
3. Samuelson TW, Ferguson TJ, Brubaker JW, et al. Negative pressure application via a multi-pressure dial to lower IOP in patients with suspected glaucoma or open angle glaucoma. J Glaucoma. 2023;32(8):708-720. doi:10.1097/IJG.0000000000002231.
