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Clinical Study Demonstrates Long Term IOP Reduction with the OMNI® Surgical System Predicate Device (TRAB®360) in Micro-Invasive Glaucoma Surgery
MENLO PARK, Calif., March 14, 2019 /PRNewswire/ -- A new, single center retrospective study of glaucoma surgery patients published in the January 2019 issue of Clinical Ophthalmology shows that ab-interno trabeculotomy using one of Sight Sciences' OMNI® Surgical System's Predicate Devices (TRAB®360) provides a favorable safety profile and substantial long-term reductions in both intraocular pressure (IOP) and IOP-lowering medications.
Conducted by Steven Sarkisian, M.D., at the Dean A. McGee Eye Institute, the consecutive case series included data on a total of 81 eyes from 69 glaucoma patients undergoing standalone micro-invasive trabeculotomy.* Nearly two-thirds of the eyes (50/81, 61.7 percent) had undergone prior glaucoma surgery.
"We are excited to announce the first publication of long-term clinical data on micro-invasive trabeculotomy with one of the OMNI® Surgical System's two predicate devices, the TRAB®360," said Paul Badawi, Founder and Chief Executive Officer of Sight Sciences. "Dr. Sarkisian was the first surgeon in the world to perform single incision 360-degree trabeculotomy in 2013, so this is a major milestone recognizing his pioneering work in circumferential canal-based MIGS."
Key study findings through the 12-month endpoint include:
- Standalone glaucoma surgery on all patients.
- 7.3mmHg mean IOP reduction from a mean medicated baseline IOP of 23.7mmHg to a mean 12-month IOP of 15.7mmHg.
- 67 percent of eyes with preoperative IOP values of ≥25 mmHg achieved ≥20 percent reduction in IOP and IOP <18 mmHg with the same or fewer numbers of IOP-lowering medications compared with those at baseline.
- The most common adverse event was transient hyphema (50.6%); 90 percent of these cases were classified as mild.
"The findings of this study are consistent with the historical body of literature on the long-term safety and efficacy of circumferential trabeculotomy in adults," said Dr. Sarkisian. "Performed in a tertiary care setting, these surgeries represent an advanced and clinically diverse patient population including POAG, pigmentary glaucoma, congenital glaucoma, neovascular glaucoma, and other types of glaucoma."
The OMNI® Surgical System is a next-generation technology that combines the distinct functions of its two predicate devices – TRAB®360 for trabeculotomy and VISCO360® for transluminal viscoelastic delivery – into one device so that all three sources of resistance in the conventional outflow pathway (trabecular meshwork, Schlemm's canal, and collector channels) can be targeted with a single device and single surgery.
"With the recent evolution from the single purpose TRAB®360 trabeculotomy device that I have been using for years to the multi-functional OMNI® Surgical System, I am pleased to offer my patients two sequential procedures in one surgical setting that can target all three sources of potential resistance in the conventional outflow pathway," said Dr. Sarkisian.
* Sarkisian SR, Mathews B, Ding K, Patel A, Nicek Z. 360° ab-interno trabeculotomy in refractory primary open-angle glaucoma. Clin Ophthalmol. 2019;13:161-168. Dr. Sarkisian is a consultant to and equity owner in Sight Sciences. This research was supported by a grant from Sight Sciences, Inc.
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.
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 TRAB®360 Trabeculotomy System is a trabeculotome, a manual surgical ophthalmic instrument used to mechanically cut trabecular meshwork.
The OMNI® Surgical System and TRAB®360 Trabeculotomy System are tools, not treatments, and are indicated for use as specified above; they are not specifically cleared by the FDA to lower intraocular pressure in patients with open angle glaucoma.
For more information, including warnings and precautions, 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.
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SOURCE Sight Sciences