Key Takeaways
- Balance Ophthalmics advances commercialization of FSYX, its ocular pressure adjusting pump technology for the treatment of glaucoma.
- Chris Lee, MS, MBA, joins the company as vice president of clinical to lead post-market research and medical affairs.
- Under HCPCS Level II code E2403, the FSYX pump is reimbursed as a capped rental at approximately $1,352.58 per month for months for the first 3 months and $1,014.44 per month for months 4 through 13.
Final Medicare payment amounts for Balance Ophthalmics’ FSYX ocular pressure adjusting pump (OPAP) and associated goggles became effective Octobter 1, the company announced.
Under HCPCS Level II code E2403, the FSYX (pronounced “physics”) pump is reimbursed as a capped rental at approximately $1,352.58 per month for months for the first 3 months and $1,014.44 per month for months 4 through 13, 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, have a final 2026 fee schedule amount of approximately $167.99 per unit.
The FDA 510(k) cleared the wireless-enabled FSYX system earlier this year and patient access as Balance moves into broader commercial execution. FSYX is a noninvasive therapy designed to lower IOP during sleep in adults with open-angle glaucoma. The system uses pressure-modulating goggles and a compact pump to apply gentle negative pressure to the eyes, providing an additional approach to IOP reduction. In clinical trials, FSYX demonstrated a 39% mean IOP reduction in nighttime eye pressure with no device-related serious adverse events reported.1 The system transmits patient usage data to the prescribing practice for greater visibility into at-home therapy use.
The company also announced the appointment of Chris Lee, MS, MBA, as vice president of clinical. Mr. Lee will lead Balance’s FDA post-market study in partnership with the clinical research organization True North. He will also lead medical affairs strategy, including key opinion leader engagement, scientific publications, and presence at major ophthalmic and optometric society meetings, while overseeing inbound research interest and helping evaluate future clinical research opportunities.
“As Medicare payment for FSYX takes effect, we are simultaneously building the team and capabilities needed to successfully bring a first-in-kind technology into clinical practice,” said Seph Jensen, chief executive officer of Balance Ophthalmics. “Chris brings a unique combination of ophthalmic clinical research, medical affairs, and commercial experience that aligns directly with where Balance is today. His leadership will be instrumental as we fulfill our post-market commitments, expand our clinical evidence, and work with physicians to establish OPAP as a meaningful new category in glaucoma care.”
1. Ferguson TJ, Samuelson TW, Herndon LW, et al. Negative pressure application by the ocular pressure adjusting pump to lower intraocular pressure in normal-tension glaucoma: HERCULES study. Am J Ophthalmol. 2025;275:121-134. doi: 10.1016/j.ajo.2025.03.030.