Sight Sciences Announces Long-Term Safety and Effectiveness Data of Standalone Use of the OMNI® Surgical System in Patients with Open Angle Glaucoma
Sight Sciences (Nasdaq: SGHT) released three-year follow-up data showing the effectiveness of the OMNI Surgical System in treating open-angle glaucoma. The study revealed a mean reduction in intraocular pressure (IOP) of over 20% for all 26 patients, with IOP decreasing from 24.6 mmHg preoperatively to 15.0 mmHg at 36 months. Additionally, the mean number of IOP-lowering medications dropped significantly. Adverse events were minimal and resolved without intervention in most cases. This data underscores the long-term safety and efficacy of the OMNI system as a standalone treatment.
- Mean IOP reduction of over 20% achieved at 36 months follow-up.
- Significant decrease in the mean number of IOP-lowering medications.
- Durable results suggest long-term effectiveness of the OMNI Surgical System.
- None.
Three-year, standalone (not combined with cataract surgery) data shows the non-implantable minimally invasive glaucoma surgery effectively reduces intraocular pressure and reduces need for IOP-lowering medications in open-angle glaucoma patients
MENLO PARK, Calif., Aug. 16, 2022 (GLOBE NEWSWIRE) -- Sight Sciences, Inc. (Nasdaq: SGHT), an eyecare technology company focused on developing and commercializing innovative solutions intended to transform care and improve patients’ lives, today announced 36-month post-surgery follow-up results of the OMNI® Surgical System. The data demonstrates that the OMNI Surgical System delivers safe, consistent, and durable results in adult patients with open-angle glaucoma (OAG) on a standalone basis.
The study showed that canaloplasty followed by trabeculotomy using the OMNI® Surgical System achieved a mean reduction in intraocular pressure (IOP) of at least 20 percent for all 26 patients (38 eyes) at 36 months follow-up. At 12, 24 and 36 months after surgery, patients’ mean preoperative IOP post medication washout decreased from 24.6±3.2 mmHg to 14.5±1.7 mmHg, 14.2±2.0 mmHg and 15.0±1.9, respectively. The mean number of IOP-lowering medications was reduced from 1.9±0.7 to 0.4±0.6, 0.6±0.7 and 0.5±0.7 at 12, 24 and 36-months. The post operative IOP and medication use reduction at 12 months remained consistent over three years, suggesting robust durable effectiveness of the OMNI Surgical System when used as a standalone intervention either in phakic or pseudophakic eyes. Only a minimal number of adverse events were reported, all of which resolved without any intervention except one eye required secondary IOP lowering intervention.
“As we continue to evaluate this patient group with the OMNI Surgical System, the results consistently show the minimally invasive procedure has the potential to offer long-standing benefits for patients with open-angle glaucoma,” said Karsten Klabe, MD, Principal Investigator, Head Surgeon of Breyer, Kaymak & Klabe Augenchirurgie. “Most patients experienced an IOP reduction of at least 20 percent and required significantly less medication, meeting the study's objective. By effectively reducing IOP and the medication burden, the OMNI Surgical System is transforming how glaucoma is cared for in both combination cataract and standalone glaucoma patients.”
The clinical observation included 38 eyes from 26 patients with OAG treated with the OMNI Surgical System. Follow-up visits were done on day 1, week 1 and months 1, 3, 6, 12, 18, 24, 30 and 36 after surgery. This trial is an extension of 24-month data that was published in Clinical Ophthalmology in June 2021.
“The OMNI Surgical System is supported by a robust clinical development program, which includes this treatment evaluation over three years in patients with open-angle glaucoma. These results highlight the long-term effectiveness and strong safety profile of the OMNI Surgical System. This non-implantable procedure has shown effectiveness without the known IOP-lowering assistance of cataract surgery. We look forward to ongoing data collection and evaluating the durability at further intervals post-microinvasive canal surgery with OMNI,” said Paul Badawi, Co-Founder and CEO, Sight Sciences.
The data results were presented in June at the 15th European Glaucoma Society (EGS) Congress in Athens, Greece.
About Sight Sciences
Sight Sciences is an eyecare technology company focused on developing and commercializing innovative solutions intended to transform care and improve patients’ lives. Using minimally invasive or non-invasive approaches to target the underlying causes of the world’s most prevalent eye diseases, Sight Sciences seeks to create more effective treatment paradigms that enhance patient care and supplant conventional outdated approaches. The Company’s OMNI® Surgical System is a minimally invasive glaucoma surgery (MIGS) device indicated to reduce intraocular pressure in adult patients with primary open-angle glaucoma (POAG), the world’s leading cause of irreversible blindness. The Company’s TearCare® System is 510(k) cleared in the United States for the application of localized heat therapy in adult patients with evaporative dry eye disease due to meibomian gland dysfunction (MGD), enabling office-based clearance of gland obstructions by physicians to address the leading cause of dry eye disease.
For more information, visit www.sightsciences.com.
About the OMNI® Surgical System
The OMNI® Surgical System is a handheld, single-use therapeutic device for minimally invasive glaucoma surgery (MIGS). It 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.
Through a single clear corneal microincision, OMNI® allows surgeons to access all 360 degrees of Schlemm’s canal and treat all three sources of outflow resistance within the eye’s diseased conventional outflow pathway (trabecular meshwork, Schlemm’s canal, and collector channels).
OMNI® is indicated by the FDA 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. OMNI has a CE Mark 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.
OMNI® should not be used in any situations where the iridocorneal angle is compromised or has been damaged since it may not be possible to visualize the angle or to properly pass the microcatheter. Do not use the OMNI® in patients with angle recession; neovascular glaucoma; chronic angle closure; narrow-angle glaucoma; traumatic or malignant glaucoma; or narrow inlet canals with plateau iris or in quadrants with previous MIGS implants.
OMNI® received its first FDA clearance in 2017 and is protected by a global patent portfolio including 32 issued patents worldwide.
OMNI® is a registered trademark of Sight Sciences.
Forward-Looking Statements
This press release, together with other statements and information publicly disseminated by the Company, contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. The Company intends such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995 and includes this statement for purposes of complying with these safe harbor provisions. Any statements made in this press release that are not statements of historical fact, including statements about our beliefs and expectations, are forward-looking statements and should be evaluated as such. Forward-looking statements include information concerning possible or assumed future results of operations, including descriptions of our business plan and strategies. These statements often include words such as “anticipate,” “expect,” “suggests,” “plan,” “believe,” “intend,” “estimates,” “targets,” “projects,” “should,” “could,” “would,” “may,” “will,” “forecast” and other similar expressions. We base these forward-looking statements on our current expectations, plans and assumptions that we have made in light of our experience in the industry, as well as our perceptions of historical trends, current conditions, expected future developments and other factors we believe are appropriate under the circumstances at such time. Although we believe that these forward-looking statements are based on reasonable assumptions at the time they are made, you should be aware that many factors could affect our business, results of operations and financial condition and could cause actual results to differ materially from those expressed in the forward-looking statements. These statements are not guarantees of future performance or results. The forward-looking statements are subject to and involve risks, uncertainties and assumptions, and you should not place undue reliance on these forward-looking statements. These forward-looking statements include, but are not limited to, statements concerning the following: estimates of our total addressable market, future revenue, expenses, capital requirements, and our needs for additional financing; our ability to enter into and compete in new markets; the impact of the COVID-19 pandemic on our business, our customers’ and suppliers’ businesses and the general economy; our ability to compete effectively with existing competitors and new market entrants; our ability to scale our infrastructure; our ability to manage and grow our business by expanding our sales to existing customers or introducing our products to new customers; our ability to establish and maintain intellectual property protection for our products or avoid claims of infringement; potential effects of extensive government regulation; our abilities to obtain and maintain regulatory approvals and clearances for our products that support our revenue projections, business strategies and growth; our ability to successfully execute our clinical trial roadmap; our ability to obtain and maintain sufficient reimbursement for our products; our abilities to protect and scale our intellectual property portfolio; our ability to hire and retain key personnel; our ability to obtain financing in future offerings; the volatility of the trading price of our common stock; our expectation regarding the time during which we will be an emerging growth company under the Jumpstart Our Business Startups Act (the “JOBS Act”); our ability to maintain proper and effective internal controls; and the other important factors discussed under the caption “Risk Factors” in our filings with the U.S. Securities and Exchange Commission, as may be updated from time to time in subsequent filings. These cautionary statements should not be construed by you to be exhaustive and are made only as of the date of this press release. We undertake no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law.
Media contact:
Carmen Caricchio
C2M Group
PR@Sightsciences.com
Investor contact:
Philip Taylor
Gilmartin Group
415.937.5406
Investor.Relations@Sightsciences.com
FAQ
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