Balance Ophthalmics said the FDA has granted 510(k) clearance for a wireless-enabled version of its FSYX Ocular Pressure Adjusting Pump (OPAP), a prescription device intended to lower intraocular pressure (IOP) during sleep in adults with open-angle glaucoma. The next-generation system adds wireless connectivity that allows ophthalmology practices to remotely monitor patient usage data from at-home therapy, according to the company. Balance Ophthalmics said the device is expected to become available in the fourth quarter of 2026. The FSYX system consists of pressure-modulating goggles connected to a compact pump that applies negative pressure to the eyes during sleep, targeting nocturnal IOP elevation, a period associated with glaucoma progression and reduced efficacy of some daytime therapies.
“Many glaucoma patients progress at night when IOP runs highest and current therapies are least effective," said Thomas W. Samuelson, founding partner and attending surgeon at Minnesota Eye Consultants, in a news release. "The OPAP is the first device designed to protect them during that window."
Balance Ophthalmics described FSYX as the first nonpharmacologic, nonsurgical device designed specifically for nocturnal IOP reduction. The company cited findings from 12 clinical studies involving more than 600 eyes that demonstrated a mean 39% reduction in nighttime IOP, with no device-related serious adverse events reported. The supporting evidence includes the HERCULES study, published in the American Journal of Ophthalmology in 2025, which evaluated negative pressure therapy in patients with normal-tension glaucoma. The device is intended for use alongside existing glaucoma therapies, including prior surgical interventions.
The multicenter HERCULES trial evaluated the FSYX ocular pressure adjusting pump in 93 patients with normal-tension glaucoma, with one eye randomized to overnight negative-pressure treatment and the fellow eye serving as a control. After 52 weeks, 88.3% of treated eyes achieved at least a 20% daytime IOP reduction, compared with 1.7% of control eyes, and mean nocturnal IOP decreased by 39.1%, from 20.4 mmHg to 12.4 mmHg. Investigators reported no serious adverse events, with the most common device-related effects limited to transient lid and periorbital edema.
Balance Ophthalmics anticipates availability of the next-generation wireless FSYX OPAP to eye care practices beginning in the 4th quarter of 2026. GP