OMNI is the first microinvasive glaucoma surgery (MIGS) device indicated to lower IOP in adult patients
Sight Sciences Receives FDA Clearance for Expanded Indication for OMNI Surgical System. (Credit: David Mark from Pixabay.)
Sight Sciences, Inc., a growth-stage medical device company focused on addressing the underlying causes of the world’s most prevalent eye conditions, today announced U.S. Food and Drug Administration (FDA) 510(k) clearance of the OMNI® Surgical System (OMNI) for canaloplasty (microcatheterization and transluminal viscodilation of Schlemm’s canal) followed by trabeculotomy (cutting of trabecular meshwork) to reduce intraocular pressure (IOP) in adult patients with primary open–angle glaucoma. While OMNI is already used for the delivery of small amounts of viscoelastic fluid during ophthalmic surgery and to cut trabecular meshwork tissue during trabeculotomy procedures, this clearance establishes OMNI as the first FDA cleared, ab interno device for standalone microinvasive glaucoma procedures (MIGS) in adult patients with primary open-angle glaucoma. Primary open-angle glaucoma is estimated to affect over 4 million people in the U.S. and over 65 million people globally, and is one of the leading causes of blindness worldwide.
Historically, the vast majority of MIGS procedures have been performed solely in combination with cataract surgery given limitations on the indications for use of MIGS implants. Sight Sciences estimates that approximately 10% of U.S. primary open-angle glaucoma patients require combination cataract surgery. This has left mild-to-moderate primary open-angle glaucoma patients who do not have a cataract without a device or procedure indicated for lowering IOP from an ab interno approach. The expanded label positions OMNI as the first comprehensive MIGS device cleared for use across the spectrum of primary open-angle glaucoma patients.
The differentiated OMNI Surgical System uniquely targets all three points of resistance (trabecular meshwork, Schlemm’s canal and collector channels) in the conventional outflow pathway. The procedure is implant-free and canal-based, offering ophthalmic surgeons and patients a safe and effective device for reducing IOP in adult primary open-angle glaucoma patients.
“This expanded indication positions OMNI for leadership in the glaucoma surgery market,” said Paul Badawi, founder and Chief Executive Officer of Sight Sciences. “The industry is rapidly moving towards our treatment algorithm of addressing all three points of outflow resistance in the conventional outflow pathway. We expect to continue to lead the way with a robust clinical roadmap that contemplates the initiation of several randomized controlled trials in the U.S. and Europe before the end of the year, which we also expect will further demonstrate that OMNI is a comprehensive and consistently effective surgical option for both standalone and combination glaucoma procedures.”
“With its expanded indication, I expect OMNI to become a standard of care in my practice for adult patients with primary open-angle glaucoma due to not only the appealing implant-free, microcatheter-based approach, but also the consistent IOP lowering results from treating more than a single quadrant of the diseased outflow anatomy and doing so at all three levels of outflow resistance,” said Dr. Reay Brown, a world-renowned glaucoma specialist and the company’s Chief Medical Officer. “OMNI allows me to combine two distinct angle procedures sequentially to address all three points of resistance with a single device and a single corneal incision. This expanded indication establishes the safety and efficacy of this comprehensive MIGS device in both combination cataract and standalone primary open-angle glaucoma patients.”
Source: Company Press Release