MENLO PARK, Calif., Aug. 26, 2020 /PRNewswire/ -- Sight Sciences, Inc., a growth-stage ophthalmic medical device company, today announced positive 6-month interim safety and efficacy results from a prospective, multicenter, historically controlled clinical trial of the OMNI® Surgical System in open angle glaucoma (OAG). The OMNI Surgical System is currently cleared for use for the delivery of small amounts of viscoelastic fluid during ophthalmic surgery, and to cut trabecular meshwork tissue during trabeculotomy procedures. Data from the study in OAG were presented at the Women in Ophthalmology (WIO) 2020 Virtual Summer Symposium held on August 21 – 23.
The GEMINI study, which included 15 investigators from 15 surgery centers across the U.S., enrolled 150 patients with mild to moderate OAG who were on one to four glaucoma medications. In the first 76 patients to complete 6 months of the study, interim results report a 75% reduction in the use of intraocular pressure (IOP)-lowering medications. Of these 76 patients, 56 (73%) did not require glaucoma medications at 6 months post-treatment allowing for an interim IOP comparison of medication-free IOP at 6 months versus baseline IOP post-medication washout. These 56 medication-free patients at 6 months experienced an average IOP reduction of 40% compared to their unmedicated baseline IOP and 95% had a >20% reduction in IOP with an IOP range between 6-18 mm Hg. The only adverse events reported – hyphema (4.6%), IOP spikes (2%), vitreous hemorrhage (1%) and iritis (1%) – were minor, transient and required no additional treatment for complete resolution. There were no incidences of recurring hyphema or loss of visual acuity, and no patient required secondary surgical glaucoma intervention. The interim results were presented by Anita Campbell, M.D., ophthalmologist with the Greene Vision Group in Wichita, Kan.
"Interim findings from the GEMINI study indicate that the OMNI Surgical System achieved a statistically significant and clinically meaningful reduction in both IOP and the use of hypotensive glaucoma medications at six months," said Dr. Campbell. "The reductions in IOP and medication use, or freedom from medications in most cases thus far, can have a truly meaningful positive impact on the quality of life for patients living with glaucoma."
"We believe these interim results further validate the physiological thesis behind OMNI and the clinical benefits of comprehensively targeting all three points of resistance in the conventional outflow pathway," said Paul Badawi, Chief Executive Officer of Sight Sciences. "We were pleased to see that our interim clinical trial outcomes from GEMINI mirror the real-world feedback shared by the surgical glaucoma community and we're looking forward to reporting on our 12-month outcomes in the first half of 2021."
About Sight Sciences Founded in 2011, Sight Sciences develops and commercializes intelligently designed and engineered products for use in procedures associated with the world's most prevalent eye diseases. The company's surgical 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.