Balance Ophthalmics announced that the US Food and Drug Administration has granted De Novo classification to the FYSX Ocular Pressure Adjusting Pump, a new treatment category for patients with normal-tension glaucoma and open-angle glaucoma with intraocular pressure (IOP) ≤21 mmHg.

“The FDA classification of FYSX marks a tremendous advance in our mission to provide better options for doctors managing their toughest glaucoma patients,” said John Berdahl, MD, founder and chair of Balance Ophthalmics.

FYSX is the first nonpharmacologic, nonsurgical treatment designed to lower IOP during sleep for glaucoma patients. This device features a compact pump and pressure-sensing goggles. FYSX could bring new hope to normal-tension glaucoma patients, who account for about 30% of glaucoma cases, said glaucoma specialist Leon Herndon, MD, in a news release.

The wearable FYSX pump provides instant IOP control and offers clinicians data on product usage, clarifying the relationship between efficacy and patient compliance. Seph Jensen, CEO of Balance Ophthalmics, emphasized the importance of establishing reimbursement and insurance coverage to ensure access for the most vulnerable patients. Balance Ophthalmics plans for commercialization and market access activities to begin in late 2025.