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