Glaucoma
Winter 2024

by Liz Hillman
Editorial Co-Director

In 2022, ASCRS and the American Glaucoma Society (AGS) issued a joint position paper that described six key areas of unmet needs in glaucoma.¹ Earlier this year, a technology was approved by the FDA that would address two of these unmet needs: the FSYX Ocular Pressure Adjusting Pump by Balance Ophthalmics. The FDA approved the FSYX Ocular Pressure Adjusting Pump in June 2024, making it the first non-surgical, non-pharmaceutical, IOP-lowering therapy for patients with open angle glaucoma.

“As a doctor, what excites me most about this approach is that it lowers IOP safely in some of our most difficult to treat patients,” said John Berdahl, MD. “Normal tension glaucoma and its accompanying nocturnal IOP elevations have been notoriously difficult to treat. Now we can get lower IOP in these patients predictably.”

Leon W. Herndon Jr., MD, said in the 2022 joint position paper, ASCRS and AGS listed the need for 24-hour IOP lowering and non-invasive IOP-lowering therapy as two of the six areas of unmet need. “That’s where the FSYX Ocular Pressure Adjusting Pump comes in. It helps to address these unmet needs in two categories that major organizations felt were important to our patients,” said Dr. Herndon, who helped with the company’s panel presentation to the FDA in March 2024. “Ever since I presented on behalf of Balance Ophthalmics to the FDA, I’ve seen several patients who might benefit. … We see patients who come in all the time with ‘controlled’ pressure during the day, but they still may be progressing. I’ve long thought that the nocturnal IOP elevation has something to do with it. I was looking at some old data back when I was a fellow. In 1995, we reviewed a paper, … and we had a conversation during journal club about needing to lower pressure when patients sleep. … Over the past several months, I thought of different scenarios where the FSYX Ocular Pressure Adjusting Pump might be beneficial, and we just need to get it into doctors’ hands.”

The FSYX Ocular Pressure Adjusting Pump system is a prescription device indicated for reducing IOP during sleep in adult patients with open angle glaucoma and IOP ≤21 mm Hg who are currently using or have undergone other IOP-lowering treatments. The device combines a quiet, compact, portable pump, a little bigger than a smartphone, with innovative pressure-sensing goggles designed to be worn at night when IOP typically goes up and most treatments are less effective. The FSYX Ocular Pressure Adjusting Pump draws a negative pressure over the eye of –5 to –20 mm Hg and results in an IOP lowering of about 50–60% of the negative pressure programmed. Patients would wear the device nightly while they sleep. 

In the multicenter randomized controlled pivotal study data, as published in the summary of the FDA’s panel meeting in March 2024, 120 eyes were analyzed at week 52 showing that 96.7% of treatment eyes versus 5.0% of control eyes met the endpoint of 20% IOP reduction at night. The mean nocturnal IOP reduction at week 52 was 8.0 mm Hg (39.1%) from a baseline of 20.4±2.5 mm Hg to 12.4±2.7 mm Hg. There were no serious adverse events.

Ocular adverse events reported in the trial included eyelid edema (11.8%), dry eye (5.4%), conjunctival hyperemia (4.3%), eye pain (3.2%), eyelid erythema (2.2%), loss of BCDVA of 10 letters or more (2.2%), and posterior vitreous detachment (2.2%). The panel reviewing the device recommended further research to ensure long-term safety with continued device use.

“I don’t know any other technology or medication that will achieve that level of success when it comes to IOP reduction, short of incisional surgery, so we’re excited about this new way to manage glaucoma,” Dr. Herndon said.

Another study that was published in September 2024 described the IOP lowering of the FSYX Ocular Pressure Adjusting Pump system as measured via direct manometry via an anterior chamber cannula that was attached to an IOP sensor, placed prior to participants’ cataract surgery.² Measurements were taken in real time at different levels of negative pressure (–10 mm Hg, –20 mm Hg, and no negative pressure). The investigators saw a dose-dependent IOP reduction and a return to baseline IOP when no negative pressure was applied. Tanner Ferguson, MD, said the study provides direct, confirmatory evidence that the device is lowering eye pressure in a consistent, repeatable fashion.

Dr. Ferguson, who served as the primary medical writer for the company and prepared for the FDA’s panel review, said the fact that the FSYX Ocular Pressure Adjusting Pump is non-pharmaceutical and non-surgical, from a safety standpoint, is attractive. “If a patient is not tolerating the device, they just take it off,” he said. “It represents a new category for lowering IOP, which is the mainstay for glaucoma treatment options.”

Another appeal of the FSYX Ocular Pressure Adjusting Pump is that it is effective at lowering IOP in patients who already have a lower baseline eye pressure. “We envision patients wearing it at night at a time when our regular therapies are less effective. SLT and drops are effective at lowering eye pressure, but they have diminished efficacy at night. The FSYX Ocular Pressure Adjusting Pump is a very effective treatment for nocturnal IOP. [There are] patients who are progressing at low eye pressure, where they come into your office and their IOP seems controlled based on your measurements, but they continue to progress based on visual field and structural testing. Those patients are likely having nocturnal IOP spikes. I think that’s where this device fits to combat the nocturnal IOP that occurs in a lot of glaucoma patients,” Dr. Ferguson said.

He continued that he thinks the system will have “important applicability in the glaucoma treatment paradigm.” For example, he said it could be a bridge for patients who aren’t doing well from a compliance standpoint on drops.

“I would much rather be proactive than reactive in the treatment of glaucoma, and I think that’s the interventional mindset that’s currently being talked about. If a patient has had a number of prior procedures, including a surgical procedure, and their pressure seems low, but you’re worried about them having IOP spikes at night, I think having the patient wear the goggles at night instead of taking a poorly tolerated eye drop is a possible use of the device,” he said. “There are motivated glaucoma patients out there who don’t do well with topical medications, so they could go this route.”

When asked about the FSYX Ocular Pressure Adjusting Pump ever being considered a first-line therapy, Dr. Ferguson said he doesn’t think it’s going to replace something like SLT or even drops as a first-line treatment. There’s still value in a one-time treatment, like SLT. The goggles, conversely, need to be worn every night. “I think from a patient perspective, it’s still more appealing to do a laser, have a sustained reduction in IOP, and not have to do something daily, especially for mild glaucoma. I still think SLT positions itself well as a first-line treatment option,” he said.

When asked if there were contraindications to the FSYX Ocular Pressure Adjusting Pump, Dr. Ferguson said if the patient had an allergy to the goggle material, that would be a contraindication. He also noted that further study should be performed on patients who have had prior filtering procedures. 

“I think the physicians who take care of patients from mild to severe are excited about this option,” Dr. Ferguson said. “It’s going to be used more in low tension glaucoma patients or patients with a low or normal baseline IOP who continue to progress despite apparent controlled daytime IOP measurements. I think over time, the use could broaden, depending on the data.”

The FSYX Ocular Pressure Adjusting Pump was not yet available commercially at the time this article went to press.

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About the physicians

John Berdahl, MD
Vance Thompson Vision
Founder, Balance Ophthalmics
Sioux Falls, South Dakota

Tanner Ferguson, MD
Vance Thompson Vision
Sioux Falls, South Dakota
South Sioux City, Nebraska

Leon W. Herndon Jr., MD
Duke University
Durham, North Carolina

References

1. Downs JC, Fleischman D. Unmet needs in the detection, diagnosis, monitoring, treatment, and understanding of primary open-angle glaucoma: a position statement of the American Glaucoma Society and the American Society of Cataract and Refractive Surgery. Ophthalmol Glaucoma. 2022;5:465–467.
2. Peters KS, et al. Manometric intraocular pressure reduction with negative pressure using ocular pressure adjusting pump goggles. Ophthalmol Glaucoma. 2024. Online ahead of print.

Relevant disclosures

Berdahl: Balance Ophthalmics
Ferguson: Balance Ophthalmics
Herndon: Balance Ophthalmics

Contact

Berdahl: john.berdahl@vancethompsonvision.com
Ferguson: tanner.ferguson@vancethompsonvision.com
Herndon: leon.herndon@duke.edu