Ocular Pressure Adjusting Pump provides sustained reduction in IOP, suggests Study
Glaucoma is a leading cause of global blindness. Intraocular pressure (IOP) remains the only clinically-validated and modifiable risk factor associated with development and progression of glaucoma. Current treatment methods all target the reduction of IOP including topical ocular medications, laser procedures, and surgeries ranging from micro-invasive glaucoma procedures to traditional filtering procedures to facilitate an alternative drainage pathway. Although the glaucoma treatment landscape has undergone considerable advancement over the last decade, the currently available treatment options have limitations and risk factors and often require the clinician to weigh effectiveness versus safety. Currently, there is no treatment option available to reduce IOP which can be categorized as non-surgical or non-pharmacological.
The Ocular Pressure Adjusting Pump, or OPAP (FYSX™ Ocular Pressure Adjusting Pump, Balance Ophthalmics, Inc., USA) is a novel treatment device that consists of a pair of pressure-sensing goggles connected to a pressure-modulating pump. When the goggles are worn by a subject, negative pressure (or vacuum) is applied to create a localized decrease in atmospheric pressure contacting the eye, leading to a corresponding decrease in IOP. This mechanism of action is based on Pascal’s law, which states that when there is a change in pressure at any point in a confined fluid, there is an equal change throughout the fluid. The design of the Ocular Pressure Adjusting Pump allows for individualized and titratable negative pressure application to each eye.
The Ocular Pressure Adjusting Pump was FDA approved in July 2024 and the IOP-lowering efficacy of the device has been well established by multiple previous studies; however, in prior work, the IOP measurements were not measured repeatedly throughout the treatment interval or involved a removal of the device to place specially designed goggles for IOP measurement during negative pressure application. Further, because no current tonometry methods allow for IOP measurements through the goggles during negative pressure application, a novel method of measurement was developed.
The present study aimed to evaluate the sustained reduction in IOP throughout an extended duration of uninterrupted negative pressure application.
Prospective, controlled, open-label, randomized, single site, pilot study. Subjects with primary open-angle glaucoma (OAG) were enrolled. One eye of each subject was randomized to receive negative pressure application; the fellow eye served as a control. The study eye negative pressure setting was programmed for 60% of the baseline IOP. Subjects wore the Ocular Pressure Adjusting Pump for 8 consecutive hours and IOP measurements occurred at 2-hour intervals for a total of 5 IOP measurements (08:00, 10:00, 12:00, 14:00, 16:00).
Nine subjects successfully enrolled and completed the study. The mean programmed negative pressure setting was −12.0 mmHg. At baseline, the mean IOP in the study eye was 21.4 ± 4.3 mmHg. The mean IOP reduction in the study eye at hours 0, 2, 4, 6, and 8 was 8.1 (37%), 6.4 (28%), 6.3 (29%), 7.3 (34%) and 6.7 (31%), respectively. All IOP measurements during negative pressure application were reduced from baseline. There were no serious adverse events.
The current IOP-lowering treatment options for glaucoma include medications, laser procedures, implantable devices, and a variety of filtering procedures. Even with the emergence and introduction of numerous novel medical and surgical options, many patients do not achieve an adequate reduction in IOP and demonstrate progression of disease despite having an apparent “controlled” IOP value. Furthermore, it is difficult to lower IOP further on patients who are already on medications or have IOPs in the low teens. This is particularly true in patients with normal-tension and severe open angle glaucoma, two subsets of glaucoma in which the current range of treatments such as lasers, medications and MIGS procedures have diminished IOP-lowering effect. Traditional, filtering surgical options offer favorable IOP-lowering results but have an increased risk profile and high rate of failure. The Ocular Pressure Adjusting Pump is a promising new treatment option that has shown consistent IOP-lowering results across multiple studies and would represent the first non-pharmacologic, non-procedural option for reduction of IOP.
The results of this study demonstrate that the IOP reduction conferred by the Ocular Pressure Adjusting Pump is sustained while the device is worn with active negative pressure with an IOP reduction exceeding 25% across 8 hours of continuous wear. Further, the safety profile of this study is consistent with prior work evaluating the device with an absence of IOP spikes following wear of the device. As the first non-surgical, non-pharmacologic option for IOP reduction, the OPAP holds promise as a potential new treatment option for patients with glaucoma.
Source: Ferguson et al; Clinical Ophthalmology 2024:18
https://doi.org/10.2147/OPTH.S492530
