{"id":459,"date":"2019-03-27T22:45:05","date_gmt":"2019-03-27T19:45:05","guid":{"rendered":"https:\/\/www.sightsciences.com\/ous\/?p=459"},"modified":"2019-03-27T22:45:05","modified_gmt":"2019-03-27T19:45:05","slug":"first-subjects-enrolled-in-clinical-study-to-evaluate-safety-and-efficacy-of-omni-surgical-system-for-multiple-micro-invasive-glaucoma-surgery-procedures","status":"publish","type":"post","link":"https:\/\/www.sightsciences.com\/ous\/first-subjects-enrolled-in-clinical-study-to-evaluate-safety-and-efficacy-of-omni-surgical-system-for-multiple-micro-invasive-glaucoma-surgery-procedures\/","title":{"rendered":"First Subjects Enrolled in Clinical Study to Evaluate Safety and Efficacy of OMNI\u2122 Surgical System for Multiple Micro-Invasive Glaucoma Surgery Procedures"},"content":{"rendered":"

MENLO PARK, Calif. \u2013\u00a0<\/strong>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\u2122 Surgical System in performing two sequential Micro-Invasive Glaucoma Surgery (MIGS) procedures \u2013 transluminal viscoelastic delivery and trabeculotomy.<\/p>\n

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\u2122 Surgical System was treated in March 2019 by Dr. Steve Vold, Medical Director of Vold Vision.<\/p>\n

\u201cThe 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.\u201d<\/p><\/blockquote>\n

\u201cThrough 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,\u201d said Dr. Steve Vold, Medical Director of Vold Vision. \u201cThe 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.\u201d<\/p>\n

The largest clinical study to date to evaluate the OMNI\u2122 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.<\/p>\n

Numerous short- and long-term benefits of the procedures that OMNI\u2122 Surgical System facilitates\u00a0 \u2013 transluminal viscoelastic delivery and trabeculotomy \u2013 have been established through multiple studies.(1),(2)\u00a0\u00a0<\/sup>In addition, there is a growing compendium of clinical experience with Sight Sciences devices totaling more than 14,000 procedures (between the OMNI\u2122 Surgical System and its predicate devices Trab\u00ae360 and Visco360\u00ae) conducted to date.(3)\u00a0<\/sup>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)<\/sup>\u00a0Schlemm\u2019s canal and the distal collector channels which make up approximately the other 40 percent of resistance.(5)<\/sup><\/p>\n

\u201cSight Sciences is committed to building upon a strong foundation of scientific evidence to help inform surgeons\u2019 clinical decisions and help them select technologies that are best suited for their individual patients,\u201d said Dr. Reay Brown, board-certified ophthalmologist and Chief Medical Officer of Sight Sciences. \u201cWe look forward to further confirming \u2013 via this large-scale, prospective, multicenter trial \u2013 that our sophisticated technology offers a compelling alternative to traditional treatments.\u201d<\/p>\n

About the Omni\u2122 Surgical System<\/strong><\/p>\n

Indications:<\/u>\u00a0The OMNI\u2122 Surgical System is a manually operated device for delivery of small amounts of viscoelastic fluid, for example Healon\u00ae or HealonGV\u00ae from Abbott Medical Optics (AMO), Amvisc\u00ae from Bausch & Lomb, or PROVISC\u00ae from Alcon, during ophthalmic surgery. It is also indicated to cut trabecular meshwork tissue during trabeculotomy procedures.<\/p>\n

Warnings:<\/u>\u00a0The OMNI\u2122 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.<\/p>\n

The OMNI\u2122 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.<\/p>\n

For more information, please visit\u00a0www.omnisurgical.com<\/strong><\/a>.\u00a0<\/strong><\/p>\n

About Sight Sciences<\/strong><\/p>\n

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\u2019s surgical glaucoma product portfolio features the OMNI\u2122 Surgical System. Its non-surgical dry eye product portfolio consists of TearCare\u00ae for ophthalmologists and optometrists. For more information, please visit\u00a0sightsciences.com<\/a>.<\/p>\n

MEDIA CONTACT:
\nKelly Bassett, Whistle Communications\/Schaefer Advertising for Sight Sciences
\nkelly@whistlepr.com<\/a>
\npr@schaeferadvertising.com<\/a>
\n214-403-8472<\/p>\n

    \n
  1. Lewis RA, von Wolff K, Tetz M, Koerber N, Kearney JR, Shingleton BJ, Samuelson TW. Canaloplasty:\u00a0 Circumferential viscodilation and tensioning of Schlemm canal using a flexible microcatheter for the treatment of open-angle glaucoma in adults \u2013 Two-year interim clinical study results.\u00a0 J Cataract Refract Surg 2009;35:814-824.<\/li>\n
  2. 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 \u2013 24 Months Follow-up. J Glaucoma 2018;27:393-401.<\/li>\n
  3. Sarkisian SR, Mathews B, Ding K, Patel A, Nicek Z. 360\u00b0 ab-interno trabeculotomy in refractory primary open-angle glaucoma. Clinical Ophthalmology 2019;13:161-168.<\/li>\n
  4. Sight Sciences, sales data on file.<\/li>\n
  5. 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.<\/li>\n<\/ol>\n","protected":false},"excerpt":{"rendered":"

    MENLO PARK, Calif. \u2013\u00a0Sight 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\u2122 Surgical System in performing two sequential Micro-Invasive Glaucoma Surgery (MIGS) procedures \u2013 transluminal viscoelastic delivery and trabeculotomy. Subjects must have mild-to-moderate primary open angle glaucoma […]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[5],"tags":[],"class_list":["post-459","post","type-post","status-publish","format-standard","hentry","category-omni"],"acf":[],"yoast_head":"\nFirst Subjects Enrolled in Clinical Study to Evaluate Safety and Efficacy of OMNI\u2122 Surgical System for Multiple Micro-Invasive Glaucoma Surgery Procedures - International<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.sightsciences.com\/ous\/first-subjects-enrolled-in-clinical-study-to-evaluate-safety-and-efficacy-of-omni-surgical-system-for-multiple-micro-invasive-glaucoma-surgery-procedures\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"First Subjects Enrolled in Clinical Study to Evaluate Safety and Efficacy of OMNI\u2122 Surgical System for Multiple Micro-Invasive Glaucoma Surgery Procedures\" \/>\n<meta property=\"og:description\" content=\"MENLO PARK, Calif. \u2013\u00a0Sight 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\u2122 Surgical System in performing two sequential Micro-Invasive Glaucoma Surgery (MIGS) procedures \u2013 transluminal viscoelastic delivery and trabeculotomy. 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