Sight Sciences announces publication of analysis from ROMEO study

Sight Sciences announced the results as published in the journal Clinical Ophthalmology of a new analysis of the ROMEO study data. This new analysis evaluated the association between the severity of glaucoma and the intraocular pressure and medication outcomes for patients treated with the OMNI Surgical System. OMNI enables a procedure intended to restore aqueous outflow of glaucomatous eyes by addressing the three areas of outflow resistance associated with the disease. The findings suggest that ab interno canaloplasty coupled with trabeculotomy using OMNI was as effective at lowering IOP and reducing medication usage in advanced glaucoma patients as it was in mild and moderate glaucoma patients. This data challenges the belief that advanced disease stage is a barrier to successful treatment outcomes for minimally invasive glaucoma surgery. ROMEO was an Institutional Review Board approved retrospective case series conducted at eleven ophthalmology practices in the United States. Participants were mainly primary open-angle glaucoma patients who had undergone the implant-free OMNI procedure, which has been cleared by the FDA for canaloplasty followed by ab interno trabeculotomy to reduce intraocular pressure in adult patients with primary open-angle glaucoma, either combined with cataract surgery or as a standalone procedure. Eyes were categorized based on visual field mean deviation, with participants assigned to a group with severity rated as mild, moderate or advanced. The study compared outcomes at 12 months. Key findings reported in the study include: Significant reductions in both IOP and IOP-reducing medications were observed. The majority of eyes experienced a reduction in IOP at Month 12, with most achieving levels of 18 mmHg or less. The percentage of IOP reduction was consistent across severity groups, with month 12 mean IOP ranging between 14 mmHg and 16 mmHg. Medication reductions were observed across all severity groups, with the majority of patients showing a reduction of at least 1 medication, indicating the effectiveness of the treatment approach. Regression analysis found no significant relationship between month 12 IOP and visual field loss, suggesting treatment outcomes were consistent irrespective of disease severity.