MENLO PARK, Calif., Aug. 10, 2020 /PRNewswire/ -- Sight Sciences, Inc., a growth-stage medical device company transforming the two fastest-growing segments in ophthalmology and optometry, glaucoma and dry eye disease, today 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.
"Glaucoma affects 80 million people globally and is the leading cause of irreversible blindness in the aging world population," said Paul Badawi, Chief Executive Officer of Sight Sciences. "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."
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.
About Sight Sciences Founded in 2011, Sight Sciences develops and commercializes intelligently designed and engineered products that target the underlying causes of the world's most prevalent eye diseases. The company's surgical glaucoma product portfolio features the OMNI Surgical System, a dually-indicated MIGS device that facilitates the performance of both ab interno trabeculotomy and transluminal viscoelastic delivery. Using proprietary multi-modal functionality, OMNI allows surgeons to target all three sources of resistance in the conventional outflow pathway (trabecular meshwork, Schlemm's canal, and collector channels) with a single device and single corneal incision.
About OMNI Surgical System 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.
The OMNI System should not be used in cases where there is insufficient visualization of the anterior chamber. The following conditions may prohibit sufficient visualization required for safe and successful cannula and microcatheter placement: corneal edema, corneal haze, corneal opacity, or any other conditions that may inhibit surgeon view.
The OMNI Surgical System is a tool, not a treatment, and is indicated for use as specified above; it is not specifically cleared by the FDA to lower intraocular pressure in patients with open angle glaucoma.