FDA grants de novo classification to Fysx ocular pressure adjusting pump

Key Takeaways

• The FDA granted de novo classification to the Fysx ocular pressure adjusting pump for patients with normal-tension glaucoma or open-angle glaucoma with intraocular pressure (IOP) of 21 mm Hg or less.
• Fysx, which is the first, nonpharmacological, nonsurgical treatment to reduce IOP, may be especially helpful for people with normal tension glaucoma. 

The FDA granted de novo classification to the Fysx ocular pressure adjusting pump for patients with normal-tension glaucoma or open-angle glaucoma with IOP of 21 mm Hg or less, according to a press release from Balance Ophthalmics. (A de novo classification means, among other things, that the device is authorized to be marketed in the US).  “We are introducing an entirely new category of glaucoma care to the market,” Seph Jensen, CEO of Balance Ophthalmics, told Healio.

Fysx is the first nonpharmacological, nonsurgical treatment to reduce IOP. The device features a quiet, compact, portable pump as well as pressure-sensing goggles that are worn at night, when IOP typically increases and other treatments are less effective, according to the release. It is indicated in patients who are using or have undergone another IOP-lowering treatment. The device also provides clinicians with data on its usage.

“Our technology leverages physics, making efficacy largely independent of baseline intraocular pressure for the first time,” John Berdahl, MD, founder and chairman of Balance Ophthalmics, 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.” 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.

The company is preparing for commercialization and market access, expected to begin in late 2025, according to the release.

Edited by Miriam Kaplan, PhD

Sources:

Alex Young and Anthony DeFino, Healio Ocular Surgery News, June 28, 2024; see source article

David Hutton, “FDA grants DeNovo classification to Balance Ophthalmics’ FYSX ocular pressure adjusting pump.” Ophthalmology Times, July 9, 2024; see source article