Eyeworld

80 | EYEWORLD | WINTER 2024 G UCOMA by Liz Hillman Editorial Co-Director 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 I n 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 technol- ogy 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-pharma- ceutical, 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 Ocu- lar 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 base- line 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. First-of-its-kind tool for glaucoma management The FSYX Ocular Pressure Adjusting Pump system combines a compact, portable pump with pressure-sensing goggles designed to be worn at night. Source: Balance Ophthalmics

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