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 and open-angle glaucoma (OAG) with IOP ≤21 mm Hg. FYSX (pronounced “physics”) is the first non-pharmacological, non-surgical treatment designed to lower IOP for glaucoma patients, the company said in a press release. 

This prescription-only device is indicated for reducing IOP during sleep in adult patients with OAG 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 pressure-sensing goggles designed to be worn at night, when IOP typically increases and other treatments are less effective.

In addition to allowing for instant control of a patient’s IOP, the wearable FYSX Ocular Pressure Adjusting Pump also provides clinicians with data on product usage. 

The company said it is preparing for commercialization and market access, with initial activity expected to begin in late 2025.