International MIGS Study Confirms Long-Term Safety and Efficacy of the OMNI® Surgical System Predicate Device (VISCO360®)
12-Month Clinical Results of Micro-Invasive Canal Viscodilation in Combination with Cataract Surgery on Over 100 Consecutive Eyes Demonstrates Long-Term IOP and Medication Reduction in Mild to Moderate POAG
Oct 22, 2019, 07:11 ET
MENLO PARK, Calif., Oct. 22, 2019 /PRNewswire/ -- Sight Sciences, Inc., today 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 intraocular pressure (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 seven 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 micro-invasive 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," said Dr. Reay Brown, Chief Medical Officer of Sight Sciences. "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 (TRAB®360). 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 TRAB®360 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.
About the OMNI® Surgical System
Indications:
CE Mark: The OMNI® Surgical System is indicated for the catheterization and transluminal viscodilation of Schlemm's canal and the cutting of trabecular meshwork to reduce intraocular pressure in adult patients with open-angle glaucoma.
United States: 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® Surgical 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. Please see the full Instructions for Use (IFU) for additional warnings and precautions.
In the United States, the OMNI® Surgical System and VISCO360® 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, 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.
SOURCE Sight Sciences
