Today's Date: April 12, 2021
United States Mint Announces First Two Honorees in American Women Quarters Program   •   HEINZ Partners With The LEE Initiative to Help Preserve Black-Owned Restaurants’ Cultural Legacy   •   California State Parks and Hipcamp Announce First of Its Kind Open Data Integration   •   Suburban Propane Teams Up with Tanger Outlets and the Charleston RiverDogs to Provide Clothing Kits and Essentials to Lowcountry   •   Meet Mini Bloom, A Clean Baby Care Brand Rooted In Nature And Backed By Science   •   Khoros Appoints April Downing as Chief Financial Officer and Sejal Amin as Chief Technology Officer   •   Reprise Commerce Lands DeMert Brands as Its First Direct US Client   •   GrandPad launches "Grand Rewards" for Mother's Day shopping to help families save money and stay connected   •   Expensify Releases First Season of New Podcast: Live Rich, Have Fun, Save the World   •   The Children's Heart Foundation's Board of Directors Names Gail Roddie-Hamlin as President and CEO   •   Ancestry® Launches New Impact Program to Foster More Connected, Resilient Communities   •   Varian Wins Best After-Sales Service Award for Radiotherapy Products in China for Fourth Consecutive Year   •   University of Phoenix Hosting Educational Equity Webinar “Healing Racism Beyond the Dialogue: What is Racism?”   •   CarMax and Dunkin’ are “Doin’ Donuts” for New 24-Hour Test Drive Experience   •   CPSC and Maxtrade Warn Consumers to Stop Using Maxtrade Coolster Youth ATVs Due to Crash Hazard and Violation of Mandatory Safet   •   Introducing Vencapital's 5th Class of Minority & Female VC Fellows   •   One Year Into the Pandemic, Groupon Study Shows People Are Ready for JODO (Joy of Doing the Ordinary)   •   Malcolm Gladwell, Ijeoma Oluo, Thomas Friedman, and Rana Foroohar to Headline National Workplace Summit, Presented by the Confer   •   Corporate Reputations Improve During a Year of Crises according to The RepTrak Company   •   Major League Baseball and SiriusXM Expand Agreement; Games Now Available to SiriusXM's Streaming-Only Subscribers
Bookmark and Share

Sight Sciences Receives FDA Clearance for Expanded Indication for OMNI Surgical System

Sight Sciences Receives FDA Clearance for Expanded Indication for OMNI Surgical System

OMNI is the first microinvasive glaucoma surgery (MIGS) device indicated to lower IOP in adult patients with primary open-angle glaucoma in a standalone, ab interno procedure

PR Newswire

MENLO PARK, Calif., March 4, 2021 /PRNewswire/ -- 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."

About Sight Sciences:

Founded in 2011, Sight Sciences develops and commercializes intelligently designed and engineered products that target the underlying causes of the world's most prevalent eye diseases. The company's surgical glaucoma product portfolio features the OMNI Surgical System, a dually-indicated MIGS device that facilitates the sequential performance of ab interno canaloplasty and ab interno trabeculotomy. Using proprietary multi-modal functionality, OMNI allows surgeons to target all three sources of resistance in the conventional outflow pathway (trabecular meshwork, Schlemm's canal, and collector channels) with a single device and single corneal incision.

About OMNI Surgical System:

The OMNI Surgical System is indicated for canaloplasty (the microcatheterization and viscodilation of Schlemm's canal) followed by trabeculotomy (the cutting of trabecular meshwork) to reduce intraocular pressure in adult patients with primary open-angle glaucoma.

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.

OMNI received its first FDA clearance in 2017 and is protected by 50 global patents.

For more information, please visit sightsciences.com.

OMNI® is a registered trademark of Sight Sciences.

© 2021 Sight Sciences. All rights reserved.

Media contact:

Shay Smith

Health+Commerce

707.971.9779

shay@healthandcommerce.com

Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/sight-sciences-receives-fda-clearance-for-expanded-indication-for-omni-surgical-system-301241080.html

SOURCE Sight Sciences, Inc.



Back to top
| Back to home page
Video

White House Live Stream
LIVE VIDEO EVERY SATURDAY
alsharpton Rev. Al Sharpton
9 to 11 am EST
jjackson Rev. Jesse Jackson
10 to noon CST


Video

LIVE BROADCASTS
Sounds Make the News ®
WAOK-Urban
Atlanta - WAOK-Urban
KPFA-Progressive
Berkley / San Francisco - KPFA-Progressive
WVON-Urban
Chicago - WVON-Urban
KJLH - Urban
Los Angeles - KJLH - Urban
WKDM-Mandarin Chinese
New York - WKDM-Mandarin Chinese
WADO-Spanish
New York - WADO-Spanish
WBAI - Progressive
New York - WBAI - Progressive
WOL-Urban
Washington - WOL-Urban

Listen to United Natiosns News