Application of negative pressure to the periocular microenvironment to lower IOP in patients implanted with telemetric IOP sensor: report of two early studies of the FSYX ocular pressure adjusting pump.

Abstract

Introduction: The purpose of this study was to determine the effect on intraocular pressure (IOP) of applying negative pressure (NP) to the periocular space, as measured by an intraocular IOP sensor in human eyes.

Methods: Eyes with open-angle glaucoma (OAG) and previously implanted with the eyemate^®-IO IOP-measuring device (Implandata Ophthalmic Products GmbH (now G-Metrics GmbH)) wore an early prototype of the FSYX™ Ocular Pressure Adjusting Pump (OPAP; Balance Ophthalmics, Inc.) in two separate studies: "Eyemate 1" and "Eyemate 2." In Eyemate 1, study eyes received periorbital NP application at -10mmHg with OPAP for 70 to 110 minutes vs no NP in the fellow control eye. In Eyemate 2, eyes wore OPAP for 8 hours of continuous NP application set to 50% of the eye's baseline IOP vs no NP in the fellow control eye. In both studies, IOP was measured in real time using the implanted eyemate-IO device. The primary effectiveness endpoint in both studies was the change from baseline IOP in the study eye, as measured with eyemate-IO.

Results: All seven study eyes demonstrated immediate and sustained reductions in IOP during NP application. In Eyemate 1, three study eyes had individual mean steady-state IOP reductions of 31%, 51%, and 23% from baseline. In Eyemate 2, four study eyes had a mean 8-hour IOP reduction of 20% from baseline. All patients tolerated goggle wear and NP application.

Conclusion: These studies provided early proof-of-concept evidence that NP application to the periocular space lowers IOP, as measured by an implanted intraocular sensor, and was well tolerated over short-term use. Given the small, uncontrolled or open-label designs, these findings are hypothesis-generating; larger, controlled studies are required to confirm efficacy and characterize safety.