MENLO PARK, Calif. – Sight Sciences today announced enrollment has begun in the Gemini clinical study, a Sight Sciences-sponsored, prospective, multi-center 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 Dr. Steve Vold, 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,” said Dr. Steve Vold, Medical Director of Vold Vision. “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 one year with an interim analysis performed at six 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.(1),(2) 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 Trab®360 and Visco360®) conducted to date.(3) 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,(4) Schlemm’s canal and the distal collector channels which make up approximately the other 40 percent of resistance.(5)
“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,” said Dr. Reay Brown, board-certified ophthalmologist and Chief Medical Officer of Sight Sciences. “We look forward to further confirming – via this large-scale, prospective, multicenter trial – that our sophisticated technology offers a compelling alternative to traditional treatments.”
About the Omni™ Surgical System
Indications: The OMNI™ Surgical System is a manually operated device for delivery of small amounts of viscoelastic fluid, for example Healon® or HealonGV® from Abbott Medical Optics (AMO), Amvisc® from Bausch & Lomb, or PROVISC® from Alcon, during ophthalmic surgery. It is also indicated to cut trabecular meshwork tissue during trabeculotomy procedures.
Warnings: The OMNI™ System should not be used in cases where there is insufficient visualization of the anterior chamber. The following conditions may prohibit sufficient visualization required for safe and successful cannula and microcatheter placement: corneal edema, corneal haze, corneal opacity, or any other conditions that may inhibit surgeon view.
The OMNI™ Surgical System is a tool, not a treatment, and is indicated for use as specified above; it is not specifically cleared by the FDA to lower intraocular pressure in patients with open angle glaucoma.
For more information, please visit www.omnisurgical.com.
About Sight Sciences
Sight Sciences is a commercial-stage medical device company dedicated to the development of intelligently designed and engineered products that address the underlying physiology of ophthalmic diseases. The company’s surgical glaucoma product portfolio features the OMNI™ Surgical System. Its non-surgical dry eye product portfolio consists of TearCare® for ophthalmologists and optometrists. For more information, please visit sightsciences.com.
- Lewis RA, von Wolff K, Tetz M, Koerber N, Kearney JR, Shingleton BJ, Samuelson TW. Canaloplasty: Circumferential viscodilation and tensioning of Schlemm canal using a flexible microcatheter for the treatment of open-angle glaucoma in adults – Two-year interim clinical study results. J Cataract Refract Surg 2009;35:814-824.
Grover DS, Smith O, Fellman RL, Godfrey DG, Gupta A, Montes de Oca I, Feuer WJ. Gonioscopy-assisted Transluminal Trabeculotomy: An Ab Interno Circumferential Trabeculotomy – 24 Months Follow-up. J Glaucoma 2018;27:393-401.
Sarkisian SR, Mathews B, Ding K, Patel A, Nicek Z. 360° ab-interno trabeculotomy in refractory primary open-angle glaucoma. Clinical Ophthalmology 2019;13:161-168.
Sight Sciences, sales data on file.
Rosenquist R, Epstein D, Melamed S, Johnson M, Grant WM. Outflow resistance of enucleated human eyes at two different perfusion pressures and different extents of trabeculotomy. Current Eye Research 1989;8:1233-1240.