Sight Sciences 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, as well as to cut trabecular meshwork tissue during trabeculotomy procedures. It allows surgeons to target all 3 points of aqueous humor outflow resistance: the trabecular meshwork, Schlemm’s canal, and distal collector channels.

The GEMINI study, which included 15 investigators from 15 surgery centers across the United States, enrolled 150 patients with mild to moderate OAG who were on 1 to 4 glaucoma medications. In the first 76 patients to complete 6 months of the study, interim results report a 75% reduction in the use of 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 vs 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 mmHg and 18 mmHg.

The only adverse events reported — hyphemia (4.6%), IOP spikes (2%), vitreous hemorrhage (1%), and iritis (1%) — were minor, were transient, and required no additional treatment for complete resolution. There were no incidences of recurring hyphemia or loss of visual acuity, and no patients required secondary surgical glaucoma interventions.

“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 6 months,” said Anita Campbell, MD, who presented the results, in a news release.

“We believe these interim results further validate the physiological thesis behind OMNI and the clinical benefits of comprehensively targeting all 3 points of resistance in the conventional outflow pathway,” said Paul Badawi, CEO 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.”