FOR IMMEDIATE RELEASE

Balance Ophthalmics Receives FDA 510(k) Clearance for Wireless-Enabled Next-Generation FSYX™ Ocular Pressure Adjusting Pump

Next-generation device delivers wireless patient usage data to eye care practices, advancing nocturnal IOP management for glaucoma patients

SIOUX FALLS, South Dakota – May 12, 2026 – Balance Ophthalmics, a medical device company advancing non-pharmacological, non-surgical treatment options for glaucoma, today announced that the FDA has granted 510(k) clearance for a wireless-enabled, next-generation version of the FSYX™ Ocular Pressure Adjusting Pump (OPAP). Building on the company’s De Novo-classified platform, the first device designed specifically for nocturnal intraocular pressure (IOP) reduction. The updated FSYX OPAP system adds wireless communication, enabling eye care practices to access real-world patient usage data from at-home therapy.

FSYX (pronounced “physics”) is the first and only non-pharmacological, non-surgical treatment designed to lower IOP during sleep in patients with glaucoma. The prescription-only system includes a compact pump and pressure-modulating goggles worn during sleep to target a critical period when IOP typically rises and conventional therapies may be less effective. Across 12 clinical studies involving more than 600 eyes, FSYX demonstrated a 39% mean IOP reduction in nighttime eye pressure with no device-related serious adverse events reported[1]. The system is designed to be used alongside existing glaucoma therapies, including prior surgical interventions. The next-generation device adds wireless connectivity, transmitting objective usage data directly to the prescribing practice to provide visibility into therapy adherence.

“Many glaucoma patients progress at night when IOP runs highest and current therapies are least effective. The OPAP is the first device designed to protect them during that window. The new wireless capability helps us detect, patient by patient, whether they're actually receiving that protection while resting comfortably in their own home.” said Thomas W. Samuelson, MD, Founding Partner and Attending Surgeon, Minnesota Eye Consultants. 

“Receiving 510(k) clearance for our next-generation FSYX OPAP builds directly on the foundation established with our De Novo classification. Wireless communication transforms the device into a connected clinical tool, giving practices insight into patient behavior at home. We are proud to bring this capability to glaucoma patients and the practices that care for them,” said Seph Jensen, Chief Executive Officer of Balance Ophthalmics.

Balance Ophthalmics anticipates availability of the next-generation wireless FSYX OPAP to eye care practices beginning in Q4 2026. The prescription-only device is delivered directly to patients for home use. Practices interested in learning more may contact Balance Ophthalmics at info@balanceophthalmics.com.

About FSYX™
FSYX™ Ocular Pressure Adjusting Pump® (OPAP) is the first and only non-invasive, non-pharmaceutical therapy designed to lower intraocular pressure (IOP) during sleep in adults with open-angle glaucoma. Developed by Balance Ophthalmics, the FSYX system combines pressure-sensing goggles with a compact pump that applies gentle negative pressure to the eyes to reduce IOP while patients sleep. The system is designed to work alongside existing glaucoma therapies, including prior surgical interventions, and enables physicians to monitor patient usage patterns to support informed, personalized care. Please visit www.balanceophthalmics.com/fsyx for more information.

About Balance Ophthalmics
Balance Ophthalmics is a medical device company developing innovative technologies to address unmet needs in glaucoma care for eye care providers and their patients. The company is focused on advancing glaucoma management through novel approaches to intraocular pressure reduction. Balance Ophthalmics is the developer of the FSYX™ Ocular Pressure Adjusting Pump® (OPAP), a non-invasive therapy designed to lower intraocular pressure during sleep in adults with open-angle glaucoma. More information can be found at www.balanceophthalmics.com.

Media Contact:
Cassy Dump
Shine Communications
Cassy@heyshine.com

[1] Ferguson TJ, Samuelson TW, Herndon LW, et al. Negative pressure application by the ocular pressure adjusting pump to lower intraocular pressure in normal-tension glaucoma: HERCULES study. Am J Ophthalmol. 2025;275:121-134. doi:10.1016/j.ajo.2025.03.034.