■ Sight Sciences, Inc., announced the publication of results from the GEMINI study showing that minimally invasive glaucoma surgery (MIGS) using the Omni Surgical System suppressed daily fluctuations in IOP. Omni is FDA approved and CE marked for canaloplasty followed by trabeculotomy to reduce IOP in adult patients with primary open-angle glaucoma and open-angle glaucoma. The manufacturer intends to continue developing Omni and obtain regulatory clearance for additional indications, according to a news release.
The prospective, 12-month, multicenter assessment, published in Clinical Ophthalmology, included 149 patients across 15 centers. Patients on existing medications were washed out before surgery, and again at the 12-month endpoint. GEMINI showed that MIGS with Omni generated a significant reduction in overall mean IOP from baseline, and less variation and amplitude of mean IOP at each diurnal time point evaluated. After surgery, 95% of patients had a diminished peak IOP compared to preoperative measurements, with an average 36% reduction in IOP at 12 months.
“We observed ... [at] 12 months, diurnal IOP monitoring off all medications, [patients’] IOP appeared stable throughout the day,” remarked Mark F. Pyfer, MD, GEMINI investigator and first author of the study, in a news release. “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.”
A higher-volume Omni device has just received an investigational device exemption from the FDA for a 459-patient clinical study to evaluate canal viscodilation in adults with primary open-angle glaucoma. The PRECISION trial will evaluate the higher-volume device from Sight Sciences compared to the iStent inject from Glaukos.
