Sight Sciences, Inc. 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 a mean IOP reduction of 8.2 mmHg (-34%). A post-hoc analysis of diurnal IOP fluctuations at one year in the GEMINI study showed that after surgery with OMNI, IOP fluctuations were significantly reduced compared to pre-surgical measurements. GEMINI 2 Clinical Outcomes: Through three years, data from the GEMINI trial and GEMINI 2 study extension reported a 20% or more reduction of IOP in patients on the same or reduced medication at 24 months (mean of 27% IOP reduction) and at 36 months (mean of 29% IOP reduction).

Sustained medication reductions at 24 and 36 months were also reported, with 77% of study patients medication-free at two years and 74% of study patients medication-free at three years post-procedure. The published 36-month long-term follow-up data from the GEMINI 2 multi-center trial, along with the published 2-year long-term follow-up data from the ROMEO 2 multi-center study, demonstrate that the beneficial reductions in IOP and medication use observed at the 12-month timepoint with the OMNI procedure were sustained for two and three years post-operatively. The low rate (1.5% over three years) of secondary surgical interventions observed over the study period suggests that patients treated with the OMNI procedure are unlikely to require more aggressive and invasive glaucoma surgery for a meaningful period of time.

Authors and affiliations: Michael D. Greenwood MD of Vance Thompson Vision, Arkadiy Yadgarov MD of Omni Eye Services, Brian E. Flowers MD of Ophthalmology Associates, Steven R. Sarkisian Jr. MD of Oklahoma Eye Surgeons, Jaime E. Dickerson Jr., PhD of Sight Sciences and North Texas Health Science Center, and Afua Ohene-Nyako of Sight Sciences. Paper Reference: Greenwood MD et al. 36-Month Outcomes from the Prospective GEMINI Study: Canaloplasty and Trabeculotomy Combined with Cataract Surgery for Patients with Primary Open-Angle Glaucoma.

Clinical Ophthalmology.