Sight Sciences, Inc. has announced the publication in Clinical Ophthalmology of its 12-month outcomes in the GEMINI study, including results from a Hispanic population subset. The final study results demonstrated that canaloplasty and trabeculotomy performed as an implant-free minimally invasive glaucoma surgery (MIGS) using the OMNI® Surgical System in conjunction with cataract surgery significantly reduced unmedicated mean diurnal intraocular pressure (IOP), medication use and daily fluctuations in IOP in patients with open-angle glaucoma (OAG).
The GEMINI study exhibited a mean unmedicated diurnal IOP reduction of 35% at month 12 and a medication reduction (before washout) of 80%. At month 12, 84.2% of eyes achieved IOP reductions > 20% from baseline, 80% of eyes were medication-free, and 76% of eyes achieved IOP between 6–18 mmHg, inclusive. In a post hoc analysis, a reduction in the variation and amplitude of mean IOP was observed at each diurnal time point evaluated. In the study, 95% of patients had a diminished peak IOP postoperatively when compared to preoperative measurements. The difference between “high” and “low” IOP at 12 months reduced an average of 36% compared to preoperative measurements. Suppression of diurnal, or daily, fluctuations in IOP, is a significant and independent risk factor for the progression of glaucoma.
In the Hispanic population subset of the GEMINI study, the unmedicated mean diurnal IOP was reduced at 12 months – also a 35% reduction, as with the larger study. At month 12, medications were reduced from 0.43 to 0.15 and the 87% of patients required no medications. As the Hispanic population is the second largest racial or ethnic demographic in the U.S., with a higher predisposition to glaucoma, this published data provides visibility of results from MIGS, specifically the OMNI Surgical System, that corroborate the larger study findings while providing specific data for the Hispanic population, which has been limited up to this point.
The GEMINI study was a prospective, 12-month, multicenter study to measure the effectiveness and safety of the OMNI Surgical System used in combination with cataract surgery in patients with mild to moderate open-angle glaucoma. The study enrolled 149 patients across 15 centers in the U.S., with 15 participating surgeons. The Hispanic (Northern Mexico/mestizo) open-angle glaucoma population encompassed 39 subjects from a tertiary referral glaucoma center in El Paso, Texas. The study had an excellent safety profile and no serious adverse events.
“The GEMINI study is yet another testament to the safety, efficacy, and durability of our micro-invasive, implant-free OMNI procedure. By circumferentially and comprehensively addressing all three points of resistance in the conventional outflow pathway, OMNI is redefining MIGS and elevating the clinical expectations within the category,” said Paul Badawi, Co-Founder and CEO, Sight Sciences. “Sight Sciences is committed to providing the eyecare professional community and the patients they serve with solutions to help limit the progression of glaucoma, the world’s leading cause of irreversible blindess.”
Read the full press release from Sight Sciences.