Sight Sciences, Inc. has announced the enrollment of the first patients in the ORION Clinical Study. The purpose of the study is to build upon the growing body of clinical evidence and accelerating commercial use of the OMNI® Surgical System in pseudophakic eyes (eyes which had previously undergone cataract surgery) by providing ophthalmic surgeons with prospective, multicenter clinical trial data from 10 sites across the United States.
The OMNI Surgical System is a manually operated device for delivery of small amounts of viscoelastic fluid, for example Healon® or HealonGV® from Abbott Medical Optics (AMO), Amvisc® from Bausch & Lomb, or PROVISC® from Alcon, during ophthalmic surgery. It is also indicated to cut trabecular meshwork tissue during trabeculotomy procedures. Sight Sciences announced the launch of the OMNI system for microinvasive glaucoma surgery (MIGS) procedures.
The ORION trial will enroll and treat a total of 110 patients. The primary effectiveness endpoint is the proportion of eyes with at least a 20% decrease in unmedicated mean diurnal intraocular pressure (DIOP) at 12 months. Secondary endpoints at 12 months include the mean change in unmedicated DIOP from baseline as well as the proportion of eyes that attain unmedicated mean DIOP between 6 and 18 mmHg. The study’s safety endpoints are the rates of eye-related adverse events; a reduction in best corrected distance visual acuity (BCVA) from baseline; and the need for a secondary surgical intervention for IOP control.
“To date, the growing microinvasive glaucoma surgery (MIGS) category consists predominantly of glaucoma surgery performed concomitantly with cataract surgery. There remains a large unmet need for a gold standard surgical solution for the millions of phakic and pseudophakic, mild-to-moderate glaucoma patients who do not need cataract surgery but require glaucoma surgery as a standalone intervention,” said Paul Badawi, Chief Executive Officer of Sight Sciences.
“Having just completed and submitted for publication our exciting retrospective review of 12-month clinical outcomes from standalone OMNI procedures in mild-to-moderate glaucoma at 11 sites across the United States, we are extremely excited to begin our trial of standalone use of OMNI in patients with mild-to-moderate glaucoma throughout the United States.”
Full press release: https://omnisurgical.com/sight-sciences-announces-first-patients-enrolled-in-orion-a-prospective-multicenter-clinical-trial-of-the-omni-surgical-system-in-pseudophakic-mild-to-moderate-glaucoma-patients/