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Sight Sciences Announces the Acceptance for Publication of GEMINI 2, a Three Year, Prospective, Multicenter Trial Demonstrating Sustained, Significant IOP and Medication Reductions Enabled with the OMNI® Surgical System Technology
Prospective, long-term trial results are consistent with the significant body of published clinical evidence demonstrating the durable safety and
About this update from Sight Sciences, Inc.
[{"type":"text","content":"Prospective, long-term trial results are consistent with the significant body of published clinical evidence demonstrating the durable safety and effectiveness of procedures enabled with the OMNI Surgical System technology MENLO PARK, Calif., Dec. 08, 2023 (GLOBE NEWSWIRE) -- Sight Sciences, Inc. (Nasdaq: SGHT) (“Sight Sciences”), an eyecare technology company focused on developing and commercializing innovative technology intended to transform care and improve patients’ lives, today announced the acceptance for publication in Clinical Ophthalmology of the prospective, multi-center, three-year GEMINI 2 trial with long-term clinical outcomes for patients treated with the OMNI® Surgical System technology (“OMNI”). Publication is currently expected by December 31, 2023. GEMINI 2, a prospective, multi-center, medication washout trial designed to obtain 36-month follow-up for patients treated in the original 12-month GEMINI trial, has been completed. Favorable results demonstrate sustained and clinically significant intraocular pressure (“IOP”) reduction of greater than 20% and clinically significant IOP lowering medication reduction at 36 months. The prospective 3-year clinical outcomes in the GEMINI 2 trial confirm and extend the previously published 12-month data from the original GEMINI trial. GEMINI 2 included 66 patients across eleven participating sites, and all patients underwent medication wash-out at the two-year and three-year endpoints so that the IOP-lowering effect of the OMNI procedure could be better isolated and assessed. The GEMINI study was the first prospective, multi-center clinical trial to assess the safety and effectiveness of OMNI procedures used in combination with cataract surgery in patients with mild to moderate primary open-angle glaucoma (“POAG”). GEMINI was designed to have eligibility criteria and pre-planned endpoints similar to the pivotal Micro Invasive Glaucoma Surgery (“MIGS”) trabecular bypass stent trials for Hydrus® Microstent and iStent inject® following ANSI Z80.27 guidelines including medication washout pre-surgically and at the endpoint. GEMINI was statistically powered and had a priori hypotheses of superiority compared to the historical control group (cataract surgery only) derived from the two stent studies. In the original GEMINI study, at 12 months, OMNI plus cataract surgery achieved...