FDA Grants DeNovo Classification to Balance Ophthalmics' FYSX Ocular Pressure Adjusting Pump

Balance Ophthalmics announced that the FDA has granted DeNovo Classification of the FYSX Ocular Pressure Adjusting Pump, a new category of treatment for patients with normal tension glaucoma (NTG) and open-angle glaucoma (OAG) with 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,” John Berdahl, MD, founder and Chair of Balance Ophthalmics, said in a company news release. “Our technology leverages physics, making efficacy largely independent of baseline intraocular pressure for the first time. 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.”

FYSX (pronounced “physics”) is the first non-pharmacological, non-surgical treatment designed to lower IOP for glaucoma patients. This prescription-only device is indicated for reducing IOP during sleep in adult patients with open-angle glaucoma and IOP ≤ 21 mmHg 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.

The wearable FYSX Ocular Pressure Adjusting Pump allows for instant control of a patient’s IOP and provides clinicians with data on product usage, according to FYSX.

“For the first time, doctors will be able to definitively know if and when their patients are using the prescribed therapy,” said Seph Jensen, CEO of Balance Ophthalmics. “This confirmation will clarify the relationship between efficacy and patient compliance, and has the potential to develop into truly personalized therapy. It’s incredibly exciting.”  

“We understand and recognize the critical need to establish reimbursement and insurance coverage to ensure access for the most vulnerable glaucoma patients who require a new effective treatment option," Mr. Jensen said. 

Balance Ophthalmics is now preparing for commercialization and market access, with initial activity expected to begin in late 2025.