FDA Grants DeNovo Classification to FYSX™ Ocular Pressure Adjusting Pump

FDA Grants DeNovo Classification to FYSX™ Ocular Pressure Adjusting Pump

July 01, 2024

Balance Ophthalmics has been granted FDA’s DeNovo Classification to their FYSX™ Ocular Pressure Adjusting Pump. This novel device represents a new category of treatment specifically designed for patients suffering from Normal Tension Glaucoma (NTG) and Open-Angle Glaucoma (OAG) with intraocular pressure (IOP) ≤ 21 mmHg.

Revolutionizing Glaucoma Care with Physics-Based Technology

Dr. John Berdahl, founder and Chair of Balance Ophthalmics, expressed enthusiasm about the FDA's decision, stating, "The FDA classification of FYSX marks a tremendous advance in our mission to provide better options for doctors managing their toughest glaucoma patients. 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™ Ocular Pressure Adjusting Pump Unveiled

FYSX, pronounced as "physics," represents the first non-pharmacological, non-surgical treatment aimed at lowering 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 other IOP-lowering treatments. The device includes a quiet, compact, portable pump integrated with innovative pressure-sensing goggles designed to be worn at night, when IOP tends to rise and conventional treatments may be less effective.

Impact on Normal Tension Glaucoma (NTG) Patients

Dr. Leon Herndon, a glaucoma specialist based in Durham, North Carolina, commented on the potential impact of FYSX, particularly for NTG patients: "I believe FYSX will bring new hope to normal tension glaucoma patients, who account for about 30% of glaucoma patients and represents those with the fewest effective treatment options. Safely and effectively lowering IOP in normal tension glaucoma is one of the biggest unmet needs in my practice. With the novel approach of FYSX, we can now manage pressures during sleep—when the optic nerve appears to be at additional risk."

Real-Time Monitoring: Enhancing Patient Management

In addition to its therapeutic benefits, the FYSX Ocular Pressure Adjusting Pump offers real-time monitoring capabilities that provide valuable insights for clinicians. Seph Jensen, CEO of Balance Ophthalmics, highlighted this aspect, stating, "For the first time, doctors will be able to definitively know if and when their patients are using the prescribed therapy. 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."

Jensen emphasized the company's commitment to ensuring accessibility of the new treatment option, noting, "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."

Balance Ophthalmics is currently preparing for commercialization and market access, with initial activities expected to commence in late 2025. This development marks a significant step forward in glaucoma treatment, offering new hope for patients and clinicians alike grappling with this challenging condition.

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