03.14.19

Study Demonstrates Long-Term IOP Reduction with the OMNI Surgical System Predicate Device (TRAB 360) in MIGS

Source: Sight Sciences

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 IOP and IOP-lowering medications. 

Conducted by Steven Sarkisian, MD, 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,” Paul Badawi, Founder and Chief Executive Officer of Sight Sciences, said in a company news release. “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,” Dr. Sarkisian said in the news release. “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.

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