Eyeworld

WINTER 2024 | EYEWORLD | 81 G Contact Berdahl: john.berdahl@ vancethompsonvision.com Ferguson: tanner.ferguson@ vancethompsonvision.com Herndon: leon.herndon@duke.edu References 1. Downs JC, Fleischman D. Unmet needs in the detection, di- agnosis, monitoring, treatment, and understanding of primary open-angle glaucoma: a position statement of the American Glaucoma Society and the Amer- ican 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 "I don't know any other technology or med- ication that will achieve that level of success when it comes to IOP reduction, short of inci- sional surgery, so we're excited about this new way to manage glaucoma," Dr. Herndon said. Another study that was published in Sep- tember 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 pres- sure 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 low- ering 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 base- line 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 pro- gressing 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 noctur- nal 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 poor- ly 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 topi- cal medications, so they could go this route." When asked about the FSYX Ocular Pres- sure 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 contraindi- cation. 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 con- trolled 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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