10.22.19

Sight Sciences: International MIGS Study Confirms Long-Term Safety and Efficacy of the OMNI Surgical System Predicate Device (VISCO360)

Source: Sight Sciences

Sight Sciences announced a new, single center study of glaucoma surgery patients published in the July 2019 issue of Clinical Ophthalmology, which shows that ab-interno microcatheterization and 360˚ viscodilation of Schlemm’s Canal using one of the OMNI Surgical System’s predicate devices (VISCO360) provides a favorable safety profile and substantial long-term reductions in both IOP and IOP-lowering medications. 

Conducted by Dr. Simon Ondrejka and Dr. Norbert Korber, the study was a retrospective analysis of 106 eyes from 71 consecutive patients with mild to moderate primary open-angle glaucoma (POAG) who were treated with the VISCO360 in combination with cataract surgery at Eye Center Cologne in Cologne, Germany.

Key findings of the study include:

  • Ab interno canal viscodilation using VISCO360 in combination with cataract surgery resulted in substantial IOP and IOP-lowering medication reductions at 12 months.
    • 41 percent IOP reduction (24.6 mmHg to 14.6 mmHg) at 12 months in eyes with a baseline pressure of 18 mmHg or more (n=72)
    • 86 percent of all eyes were medication free at 12 months
  • The most common adverse event was hyphema (13 percent of eyes). In all cases, hyphema resolved within 7 days without any intervention.
  • No eyes required additional surgical intervention to control IOP over the 12-month follow-up period.

“We are excited to announce the first publication of long-term clinical data on microinvasive viscodilation of Schlemm’s canal with one of the OMNI Surgical System’s two predicate devices, the VISCO360. The findings of this study show a consistency in IOP and medication reduction between ab interno canal viscodilation and ab externo canal viscodilation,” Dr. Reay Brown, Chief Medical Officer of Sight Sciences, said in a company news release. “These exciting clinical results from one of OMNI’s two predicate devices (VISCO360) follow on the heels of the 2019 publication of the long-term safety and efficacy of ab interno trabeculotomy using OMNI’s second predicate device (TRAB360). We continue our commitment to building a very robust retrospective and prospective clinical data set on OMNI and its two procedures – canal viscodilation and trabeculotomy – that have been combined together using OMNI so that anterior segment surgeons can efficiently and sequentially target all three sources of outflow resistance in the conventional outflow pathway for the first time using a single device in back-to-back procedures.”

Commercially launched in early 2018, the OMNI Surgical System combines the distinct functions of its two predicate devices – VISCO360 for transluminal viscoelastic delivery and TRAB360 for transluminal trabeculotomy – into one device. In so doing, the sequential OMNI procedures enable the comprehensive targeting of all three sources of resistance in the conventional outflow pathway (trabecular meshwork/trabeculotomy, Schlemm’s canal/viscodilation, and collector channels/viscodilation) using a single device and a single clear corneal incision.

 

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