Sight Sciences Announces Long-Term Safety and Efficacy Data for Standalone Use of the OMNI® Surgical System in Patients With Open-Angle Glaucoma


Three-year stand-alone data (not combined with cataract surgery) shows minimally invasive, non-implantable glaucoma surgery effectively reduces intraocular pressure and reduces the need for IOP-lowering drugs in patients with open-angle glaucoma

MENLO PARK, Calif., Aug. 16, 2022 (GLOBE NEWSWIRE) — Vision Sciences, Inc. (Nasdaq: SGHT), an eye care technology company focused on developing and commercializing innovative solutions to transform care and improve the lives of patients, today announced post-operative follow-up results from 36 OMNI month® Surgical system. The data demonstrates that the OMNI Surgical System provides safe, consistent, and durable results in adult patients with open-angle glaucoma (OAG) on a stand-alone basis.

The study showed that canaloplasty followed by trabeculotomy using the OMNI® Surgical System achieved a mean intraocular pressure (IOP) reduction of at least 20% for all 26 patients (38 eyes) at 36 months of follow-up. At 12, 24, and 36 months after surgery, patients’ mean preoperative IOP after drug withdrawal 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 drugs 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 . Postoperative IOP and reduction in medication use at 12 months remained constant over three years, suggesting robust and long-lasting efficacy of the OMNI Surgical System when used as a stand-alone intervention in phakic or pseudophakic eyes. Only a minimal number of adverse events were reported, all of which resolved without any intervention except for one eye which required secondary IOP reduction intervention.

“As we continue to evaluate this group of patients with the OMNI Surgical System, the results consistently show that the minimally invasive procedure has the potential to provide long-term benefits to patients with open-angle glaucoma,” Karsten said. Klabe, MD, Principal Investigator, Chief Surgeon of Breyer, Kaymak & Klabe Augenchirurgie. “Most patients experienced an IOP reduction of at least 20% and required significantly less medication, which is the goal of the study. By effectively reducing IOP and medication burden , the OMNI Surgical System transforms the way glaucoma is managed in both patients with combined cataract and autonomic glaucoma.

The clinical observation included 38 eyes of 26 OAG patients treated with the OMNI Surgical System. Follow-up visits were performed on day 1, week 1, and months 1, 3, 6, 12, 18, 24, 30, and 36 after surgery. This test is an extension of 24 month data published in Clinical Ophthalmology in June 2021.

“The OMNI Surgical System is supported by a robust clinical development program, which includes this three-year treatment evaluation in patients with open-angle glaucoma. These results highlight the long-term efficacy and strong safety profile of the OMNI Surgical System. This non-implantable procedure has been shown to be effective without the known IOP-lowering aid of cataract surgery. We look forward to ongoing data collection and sustainability assessment at additional intervals after micro-invasive root canal surgery with OMNI,” said Paul Badawi, co-founder and CEO of Sight Sciences.

Data results were presented in June at the 15e Congress of the European Glaucoma Society (EGS) in Athens, Greece.

About vision science

Sight Sciences is an eye care technology company focused on developing and commercializing innovative solutions to transform care and improve the lives of patients. By 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 improve patient care and supplant outdated conventional approaches. The OMNI of society® The 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. Company TearCare® The system is 510(k) cleared in the United States for the application of localized heat therapy in adult patients with evaporative dry eye due to Meibomian Gland Dysfunction (MGD), allowing physicians to eliminate office blockages of the glands to treat the primary cause of dry eye.

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About OMNI® Surgical system

THE OMNI® Surgical System is a portable, single-use therapy 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 the 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 360 degrees of Schlemm’s canal and address all three sources of flow resistance in the eye’s diseased conventional outflow pathway (trabecular, Schlemm’s canal and collecting ducts).

OMNI® is indicated by the FDA for canaloplasty (the microcatheterization and viscodilation of Schlemm’s canal) followed by trabeculotomy (the cutting of the trabecular meshwork) to reduce intraocular pressure in adult patients with primary open-angle glaucoma. OMNI is CE marked for catheterization and transluminal viscodilation of Schlemm’s canal and cutting of the trabecular meshwork to reduce intraocular pressure in adult patients with open-angle glaucoma.

OMNI® should not be used in situations where the iridocorneal angle is compromised or has been damaged as it may be impossible to visualize the angle or pass the microcatheter properly. Do not use the OMNI® in patients with angular recession; neovascular glaucoma; chronic angle closure; angle-closure glaucoma; traumatic or malignant glaucoma; or narrow entry channels with plateau or quadrant irises with anterior MIGS implants.

OMNI® received its first FDA clearance in 2017 and is protected by a global patent portfolio comprising 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 released 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 that such forward-looking statements 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 the purposes of complying with such safe harbor provisions. All 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 regarding possible or expected future operating results, including descriptions of our business plan and strategies. These statements often include words such as “anticipate”, “expect”, “suggest”, “plan”, “believe”, “intend”, “estimate”, “target”, “project”. , “should”, “could”, “would”, “may”, “will”, “plan” 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 that we deem appropriate. under the circumstances at that 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 differ significantly from those expressed. in forward-looking statements. These statements are not guarantees of future performance or results. Forward-looking statements are subject to and involve risks, uncertainties and assumptions, and you should not place undue reliance on such forward-looking statements. These forward-looking statements include, but are not limited to, statements regarding the following: estimates of our total addressable market, future revenues, expenses, capital requirements and our additional funding requirements; our ability to enter and compete in new markets; the impact of the COVID-19 pandemic on our business, the businesses of our customers and suppliers and the economy generally; 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 infringement claims; the potential effects of extensive governmental 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 ability to protect and evolve our intellectual property portfolio; our ability to hire and retain key personnel; our ability to obtain financing in connection with future offerings; the volatility of our common stock price; our expectations regarding the period during which we will be an emerging growth company under the Jumpstart Our Business Startups Act (the “JOBS Act”); our ability to maintain appropriate and effective internal controls; and other important factors discussed under “Risk Factors” in our filings with the United States Securities and Exchange Commission, as may be updated from time to time in subsequent filings. These cautionary statements should not be construed by you as being exhaustive and speak 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

[email protected]

Investor contacts:
Philip Taylor
Gilmartin Group

[email protected]

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