Sight Sciences announced the enrollment of the first patients in the ORION clinical study. The purpose of the study is to build upon the body of clinical evidence and commercial use of the OMNI Surgical System in pseudophakic eyes by providing ophthalmic surgeons with prospective, multicenter clinical trial data from 10 sites across the United States.
The primary effectiveness endpoint of the ORION trial is the proportion of eyes with at least a 20% decrease in unmedicated mean diurnal intraocular pressure (DIOP) at 12 months. A total of 110 patients will be enrolled and treated at 10 study sites in the U.S. 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.
“Glaucoma affects 80 million people globally and is the leading cause of irreversible blindness in the aging world population,” Paul Badawi, Chief Executive Officer of Sight Sciences, said in a company news release. “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. 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. We are also thrilled to announce that Dr. Mark Gallardo, a world class glaucoma specialist and one of the foremost canal physiology experts, has just performed the first five successful treatments in ORION.”
“The ORION study is among several planned multicenter retrospective and prospective MIGS clinical trials evaluating the OMNI Surgical System and we’re excited that ORION enrollment has officially begun with Dr. Gallardo’s first cases,” said Thomas Samuelson, MD, attending surgeon and founding partner of Minnesota Eye Consultants, who serves as the principal investigator of the study. “I have personally been using OMNI in many of my pseudophakic glaucoma patients because the device addresses three distinct points of potential resistance in the conventional outflow pathway — the trabecular meshwork, Schlemm’s canal, and the distal collector system –all within a single surgery. I am looking forward to a well-executed, prospective standalone ORION study in collaboration with the Sight Sciences team and an exceptional group of clinical investigators across the country. Based on my personal experience with standalone OMNI surgery and the encouraging results thus far, I believe it is time to investigate this option further in this formal, well controlled study to help benefit patients with mild-to-moderate glaucoma who have already undergone cataract surgery.”