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
