Key Takeaways
- CMS establishes final payment amounts for FSYX pump and goggles effective October 1.
- The FSYX Ocular Pressure Adjusting Pump is a noninvasive therapy designed to lower IOP during sleep.
- Under HCPCS Level II code E2403, the FSYX pump will be reimbursed as a capped rental at approximately $1,352.58 per month for 1 to 3 months and $1,014.44 per month for 4 to 13 months, resulting in a total capped Medicare payment of $14,202.09 per beneficiary following 13 months of continuous use.
Balance Ophthalmics, announced that the Centers for Medicare & Medicaid Services (CMS) has established final 2026 Medicare payment amounts for the FSYX Ocular Pressure Adjusting Pump (OPAP) and associated goggles, which take effect October 1, 2026.
Under HCPCS Level II code E2403, the FSYX pump will be reimbursed as a capped rental at approximately $1,352.58 per month for the first 3 months and $1,014.44 per month for 4 to 13 months, resulting in a total capped Medicare payment of $14,202.09 per beneficiary following 13 months of continuous use. The FSYX goggles, assigned HCPCS Level II code A6610, received a final 2026 fee schedule amount of approximately $167.99 per unit.
“Final Medicare pricing is an important validation of the OPAP category and another meaningful milestone as we prepare to commercialize FSYX,” said Seph Jensen, chief executive officer of Balance Ophthalmics. “With FDA clearance, HCPCS coding and now final Medicare payment amounts in place, the infrastructure of Balance is coming together to support physician adoption and patient access. We believe this creates a strong foundation not only for the launch of FSYX, but for establishing OPAP as a meaningful new category in glaucoma care.”
FSYX (pronounced “physics”) is a prescription-only, noninvasive therapy designed to lower IOP during sleep in adults with open-angle glaucoma. The system combines pressure-modulating goggles with a pump that applies gentle negative pressure to the eyes while patients sleep. Across 12 clinical studies involving more than 600 eyes, FSYX demonstrated a 39% mean reduction in nighttime IOP with no device-related serious adverse events reported.
The wireless-enabled FSYX system also transmits objective patient usage data directly to the prescribing practice, providing clinicians with greater visibility into at-home therapy use. The system is designed to be used alongside existing glaucoma therapies, including prior surgical interventions.
Balance Ophthalmics anticipates availability of FSYX OPAP to eye care practices in Q4 2026.
