Sight Sciences, Inc. announced the publication of two-year results of the ROMEO (Retrospective, Observational, Multicenter, Evaluation of OMNI) study in Clinical Ophthalmology.
The longest multicenter study of the OMNI Surgical System technology to date in both standalone and combination-cataract surgery demonstrated that the significant reductions in intraocular pressure (IOP) and medication usage observed at 12 months were also witnessed at 24 months. In addition, there were no serious or unanticipated adverse events during the length of the two-year study.
“This longer-term data set representing patients treated at multiple centers throughout the country both at the time of cataract surgery and as a standalone treatment should give eye surgeons even greater confidence about the safety and durability of efficacy of the OMNI Surgical System technology,” said Blake Williamson, MD, of The Williamson Eye Center in Baton Rouge, LA, and a principal investigator of the study. “Knowing that OMNI maintains effectiveness through two-years, and beyond, is very reassuring, not only to me, but also to my patients.”
Sites participating in this extension study accounted for 86 percent of eyes enrolled in the original ROMEO study from seven multi-specialty ophthalmology practices in six states (Arkansas, California, Kansas, Louisiana, Missouri, and New York).
Patients with mild-moderate glaucoma received outflow restorative procedures enabled with the OMNI Surgical System technology either at the time of cataract surgery (n = 43) or as a standalone treatment (n = 29).
Patients were divided into high baseline IOP (pre-operative IOP > 18 mmHg, n = 34) and low baseline IOP cohorts (pre-operative IOP ≤ 18 mmHg, n = 38).
Average IOP in the high baseline IOP cohort fell 31% (from 21.9 mmHg to 15.2 mmHg) at two years, which included an average reduction of 28% among combination cataract patients (n = 17) and an average reduction of 33% among standalone patients (n = 17). The study also observed a 33% reduction in medication usage on average among all patients at 24 months.
“This newest two-year follow-up data from the ROMEO study demonstrates that restorative outflow procedures with our OMNI technology continue to provide consistent and long-term lowering of IOP and glaucoma medication use when performed at the time of cataract surgery and as a standalone treatment,” said Paul Badawi, co-founder and CEO of Sight Sciences. “We plan to share additional clinical data that will further illustrate the long-term benefits of our OMNI technology over the coming years.”
The OMNI Surgical System enables surgeons to provide minimally invasive, implant-free surgery to reduce IOP in adults with primary open-angle glaucoma. The procedure intends to restore outflow by targeting all three known points of resistance in the aqueous outflow system: the trabecular meshwork, Schlemm’s canal, and the collector channels. It can be used before, in combination with, or following cataract surgery.
The study, Canaloplasty and Trabeculotomy with the OMNI System in Patients with Open-Angle Glaucoma: Two-Year Results from the ROMEO Study, was published this month in Clinical Ophthalmology can be found at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10086214.