First Subjects Enrolled in Clinical Study to Evaluate Safety and Efficacy of OMNI Surgical System for MIGS Procedures
Sight Sciences announced that enrollment has begun in the Gemini clinical study, a Sight Sciences-sponsored, prospective, multicenter study to evaluate the safety and efficacy of the OMNI Surgical System in performing two sequential micro-invasive glaucoma surgery (MIGS) procedures—transluminal viscoelastic delivery and trabeculotomy.
Subjects must have mild-to-moderate primary open angle glaucoma (POAG) and be scheduled to undergo cataract surgery to be in the study. The first Gemini study subject to have surgery performed with the OMNI Surgical System was treated in March 2019 by Steve Vold, MD, Medical Director of Vold Vision.
“Through this rigorously designed study, we hope to further validate the long-term treatment benefits associated with performing multiple MIGS procedures during one surgery. Our goal of intervening earlier in the disease stage with multiple mechanisms of action is to generate the most efficacy possible while maintaining the optimal safety profile of MIGS,” Dr. Vold said in a company news release. “The OMNI Surgical System targets the three points of resistance in the conventional outflow pathway; this medical technology has the potential to become a leading option in the MIGS space.”
The largest clinical study to date to evaluate the OMNI Surgical System, the Gemini study will enroll up to 130 subjects from 10 to 15 medical centers in the United States. Participants will be followed for 1 year with an interim analysis performed at 6 months.
Numerous short- and long-term benefits of the procedures that OMNI Surgical System facilitates – transluminal viscoelastic delivery and trabeculotomy – have been established through multiple studies. In addition, there is a growing compendium of clinical experience with Sight Sciences devices totaling more than 14,000 procedures (between the OMNI Surgical System and its predicate devices Trab360 and Visco360) conducted to date. These procedures target the three potential points of resistance in the conventional outflow pathway: the trabecular meshwork which accounts for approximately 60 percent of the resistance, Schlemm’s canal and the distal collector channels which make up approximately the other 40 percent of resistance.
“Sight Sciences is committed to building upon a strong foundation of scientific evidence to help inform surgeons’ clinical decisions and help them select technologies that are best suited for their individual patients,” Reay Brown, MD, board-certified ophthalmologist and Chief Medical Officer of Sight Sciences, said in the news release. “We look forward to further confirming – via this large-scale, prospective, multicenter trial – that our sophisticated technology offers a compelling alternative to traditional treatments.”