Sight Sciences begins enrollment in ORION study
Sight Sciences has initiated patient enrollment in the ORION clinical study of the Omni surgical system in pseudophakic eyes, according to a press release.
The prospective, multicenter clinical trial will include more than 110 patients with mild to moderate glaucoma at 10 sites across the U.S.
The primary endpoint is the proportion of eyes with at least a 20% decrease in unmedicated mean diurnal IOP at 12 months. Secondary endpoints include the mean change in diurnal IOP from baseline and the proportion of eyes that achieve unmedicated mean diurnal IOP between 6 mm Hg and 18 mm Hg. Safety endpoints include the rate of eye-related adverse events, reduction in best corrected distance visual acuity from baseline and the need for a secondary surgery for IOP control, according to the release.
“Having just completed and submitted for publication our exciting retrospective review of 12-month clinical outcomes from stand-alone Omni procedures in mild to moderate glaucoma at 11 sites across the United States, we are extremely excited to begin our trial of stand-alone use of Omni in patients with mild to moderate glaucoma throughout the United States,” Paul Badawi, CEO of Sight Sciences, said in the release.
The Omni system delivers a small amount of viscoelastic fluid during ophthalmic surgery, and it is indicated to cut the trabecular meshwork during trabeculotomy procedures. It is not cleared by the FDA to lower IOP in patients with open-angle glaucoma.