■ Encompassing the longest follow-up on the Omni Surgical System to date, 2-year results of the multicenter ROMEO study were published in Clinical Ophthalmology. With the technology employed both as a standalone procedure and in combination with cataract surgery, patients had continued significant reductions in IOP and medication usage at 24 months. There were no serious or unanticipated adverse events.
“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, Louisiana, and a principal investigator of the study. “Knowing that Omni maintains effectiveness through 2 years, and beyond, is very reassuring, not only to me, but also to my patients.”
Patients with mild to 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). The average pressure in patients with high baseline IOP fell 31% (21.9 mmHg to 15.2 mmHg) at 2 years. The study also observed an average 33% reduction in medication usage among all patients at 24 months.
Sight Sciences also announced 12-month results from the first MIGS comparative analysis of real-world data using the AAO’s IRIS Registry. Patients undergoing Omni experienced a greater average reduction in IOP-lowering medication usage compared to other MIGS procedures or cataract surgery alone.
The retrospective subanalysis presented at ASCRS 2023 in San Diego evaluated IOP-lowering medication use following the 3 most performed, FDA approved (or cleared) MIGS procedures in patients with mild glaucoma. There were 16,789 patients included who had (1) procedures enabled by Omni in combination with cataract surgery, (2) iStent Inject (Glaukos) in combination with cataract surgery, (3) Hydrus (Alcon) in combination with cataract or (4) cataract surgery alone.
Patients in the Omni cohort experienced the greatest average medication reduction with a mean reduction from baseline of 1.01 glaucoma medications at 12 months (P<.001) when compared to iStent Inject in combination with cataract surgery as well as cataract surgery alone.
“We should be open to tailoring treatment options in a patient-specific way, including offering MIGS as a means for both IOP and medication reduction,” said presenter Michael Mbagwu, MD, adjunct clinical instructor of ophthalmology at Stanford University School of Medicine and senior medical director of Verana Health, in a news release from Sight Sciences.
Sight Sciences also announced that Cigna Healthcare has updated its policy to cover ab interno canaloplasty and goniotomy (trabeculotomy) procedures, including Omni.
“We are pleased that Cigna has expanded coverage and increased patient access to more minimally invasive glaucoma surgeries,” stated Elena Sturman, president and CEO of the Glaucoma Foundation, in a news release. “Glaucoma is the leading cause of irreversible blindness in the United States. Improving access to less invasive outflow restorative procedures (associated with Omni technology) is an important addition for glaucoma patients.”
Cigna Healthcare’s updated Glaucoma Surgical Procedures policy can be found here: https://static.cigna.com/assets/chcp/pdf/coveragePolicies/medical/mm_0035_coveragepositioncriteria_viscocanolostomy.pdf .