Sight Sciences has enrolled first patients in the ORION clinical study that evaluates OMNI Surgical System in patients with mild-to-moderate glaucoma.
The prospective, multicenter clinical trial is being conducted at ten sites across the US and aims to accelerate the commercial launch of the OMNI Surgical System.
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Sight’s OMNI Surgical System is a manually operated device designed for the delivery of small amounts of viscoelastic fluid during ophthalmic surgery.
Additionally, it is indicated for use in trabeculectomy procedures to cut trabecular meshwork tissue.
Sight Sciences CEO Paul Badawi said: “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 US, we are extremely excited to begin our trial of standalone use of OMNI in patients with mild-to-moderate glaucoma throughout the US.
“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.”
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By GlobalDataThe primary effectiveness endpoint of the ORION trial, which will enrol 110 patients, is the proportion of eyes with at least a 20% decrease in unmedicated mean diurnal intraocular pressure (DIOP) at 12 months.
The study’s safety endpoints include the rates of eye-related adverse events, a decrease in best-corrected distance visual acuity (BCVA) from baseline and the need for a secondary surgical intervention for IOP control.
ORION clinical study principal investigator Thomas Samuelson said: “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.”
Glaucoma affects 80 million people worldwide and is considered to be a leading cause of irreversible blindness in the ageing world population.
