MIGS with OMNI system linked with diminished diurnal IOP fluctuations, a risk factor for glaucoma progression

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The 12-Month OMNI data from the prospective, multicenter GEMINI clinical trial show statistically significant postoperative reductions in mean IOP and suppression of daily IOP fluctuations.

Sight Sciences Inc. has announced favorable data showing that microinvasive glaucoma surgery (MIGS) using the OMNI Surgical System suppressed daily fluctuations in IOP – a meaningful and independent risk factor for the progression of glaucoma.

The results were published in Clinical Ophthalmology.

According to the company, OMNI is cleared by the FDA and CE-Marked for canaloplasty followed by trabeculotomy to reduce IOP in adult patients with primary open-angle glaucoma (POAG) (FDA) and open-angle glaucoma (CE).* Sight Sciences intends to further develop OMNI and seek regulatory clearance for expanded indications.

The importance of IOP reduction to limit or halt disease progression is well known and has been demonstrated in landmark studies such as the Advanced Glaucoma Intervention Study (AGIS) and the Early Manifest Glaucoma Trial (EMGT). The importance of daily IOP fluctuation in glaucoma progression is also generally accepted.

Results from the GEMINI study showed that MIGS using the OMNI Surgical System resulted in a significant reduction in overall mean IOP from baseline, and in a post hoc analysis, a reduction in the variation and amplitude of mean IOP was observed at each diurnal time point evaluated. In the study, 95% of patients had a diminished peak IOP postoperatively when compared to preoperative measurements. The difference between “high” and “low” IOP at 12 months reduced an average of 36% compared to preoperative measurements.

“Post hoc analysis of the GEMINI data suggests that ab-interno canaloplasty plus goniotomy using the OMNI Surgical System combined with cataract surgery has the potential to control IOP fluctuations, a known risk factor for the progression of glaucoma,” Mark F. Pyfer, MD, of Northern Ophthalmic Associates in Jenkintown, Pennsylvania, GEMINI investigator and first author of the study, said in a statement.

Pyfer noted that the team observed that when many of its GEMINI study patients returned for 12-month diurnal IOP monitoring off all medications, their IOP appeared stable throughout the day.

“This observation motivated our post hoc analysis of the GEMINI study data, showing that the 12-month variability of patients’ IOP measurements decreased significantly from preoperative levels, essentially flattening the diurnal curve during the daytime,” he said.

The GEMINI study was a prospective, 12-month, multicenter study of the effectiveness and safety of the OMNI Surgical System used in combination with cataract surgery in patients with mild to moderate open-angle glaucoma. The study enrolled 149 patients across 15 centers in the U.S., with 15 participating surgeons. Patients were “washed out” of their pre-study IOP-lowering medications before surgery, and again at the 12-month endpoint, to ensure study results were not confounded by medication use.

Paul Badawi, co-founder and CEO, Sight Sciences, said the company believes this post hoc analysis of the GEMINI study is meaningful because it shows that OMNI not only lowers IOP by addressing all three points of resistance in the conventional pathway (trabecular meshwork, Schlemm’s canal, distal collector channels), but treatment with OMNI also decreased the magnitude of daily IOP fluctuations, known to be a significant and independent risk factor for disease progression.

“OMNI uniquely enables clinicians to perform canaloplasty followed by trabeculotomy and address all three points of resistance in the diseased conventional outflow pathway with a single device through a single clear corneal microincision,” he said in a statement. “We believe, with this post hoc analysis, we are the first company to observe a ‘flattened diurnal curve,’ an important clinical finding that further supports OMNI’s differentiated clinical outcomes and our forward-thinking leadership in the MIGS category.”

Reference
1. Pyfer MF, Gallardo M. Suppression of Diurnal (9AM–4PM) IOP Fluctuations with Minimally Invasive Glaucoma Surgery: An Analysis of Data from the Prospective, Multicenter, Single-Arm GEMINI Study. Clinical Ophthalmology. Published September 24, 2021: 3131-3138. doi.org/10.2147/OPTH.S325394