FDA grants de novo classification to Fysx ocular pressure adjusting pump
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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.
“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 portable pump as well as pressure-sensing googles that are worn at night, when IOP typically increases, 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.
The company is preparing for commercialization and market access, expected to begin in late 2025, according to the release.
“The FDA de novo classification of Fysx brings an important new option for clinicians as we need more predictable options to take care of our toughest to treat glaucoma patients,” John Berdahl, MD, founder and chair of the board of Balance Ophthalmics, told Healio.
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