FDA grants DeNovo classification to Balance Ophthalmics' FYSX ocular pressure adjusting pump

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Balance Ophthalmics announced the FDA has granted DeNovo classification of the FYSX Ocular Pressure Adjusting Pump, a new category of treatment for patients with normal-tension glaucoma (NTG) and open-angle glaucoma (OAG) with intraocular pressure (IOP) ≤ 21 mm Hg.

John Berdahl, MD, founder and chairman of Balance Ophthalmics, pointed out in a news release the FDA classification of FYSX marks a tremendous advance in the company’s mission to provide better options for doctors managing their toughest glaucoma patients.

“Our technology leverages physics, making efficacy largely independent of baseline intraocular pressure for the first time,” he said in the news release. “This breakthrough makes normal tension glaucoma much more treatable, even for patients already on other treatments. Clinicians now have a predictable way to manage IOP in their most challenging cases.”

According to the company, FYSX is the first non-pharmacological, non-surgical treatment designed to lower IOP for glaucoma patients.

Moreover, according to the news release, the prescription-only device is indicated for reducing IOP during sleep in adult patients with open-angle glaucoma and IOP ≤ 21 mm Hg who are currently using or have undergone another IOP-lowering treatment.

FYSX features a quiet, compact, portable pump combined with innovative pressure sensing goggles designed to be worn at night, when IOP typically increases and other treatments are less effective.

Leon Herndon Jr., MD, a glaucoma specialist based in Durham, North Carolina, pointed out the device offers hope to patients diagnosed with normal tension glaucoma, who account for about 30% of glaucoma patients and represents those with the fewest effective treatment options.

“Safely and effectively lowering IOP in normal tension glaucoma is one of the biggest unmet needs in my practice,” Herndon said in the news release. “With the novel approach of FYSX, we can now manage pressures during sleep—when the optic nerve appears to be at additional risk.”

The wearable pump offers instant control of a patient’s IOP and also provides clinicians with data on product usage.

“For the first time, doctors will be able to definitively know if and when their patients are using the prescribed therapy,” said Seph Jensen, CEO of Balance Ophthalmics.

Jensen said the confirmation will clarify the relationship between efficacy and patient compliance, and has the potential to develop into truly personalized therapy.

“We understand and recognize the critical need to establish reimbursement and insurance coverage to ensure access for the most vulnerable glaucoma patients who require a new effective treatment option,” Jensen said in the news release.

According to the news release, Balance Ophthalmics is now preparing for commercialization and market access, with initial activity expected to begin in late 2025.