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Sight Sciences Announces Publication of Clinical Data Demonstrating Standalone Effectiveness of the OMNI® Surgical System in Pseudophakic Glaucoma Patients with Uncontrolled Pressure Following a Previous Combination Cataract Stent Procedure

May 28, 2024

 

Multicenter Clinical Data from Five US sites Published in International Ophthalmology

 

  • Worldwide, more than one million trabecular microbypass stents have been implanted in combination with cataract surgery.
  • Despite glaucoma medications and prior microbypass stenting, target IOP may no longer be achieved over time.
  • During 3 to 42 months follow-up, the majority of these standalone study patients treated with OMNI regained IOP control and avoided traditional surgery.

MENLO PARK, Calif., Nov. 03, 2022 (GLOBE NEWSWIRE) — Sight Sciences, Inc. (Nasdaq: SGHT), an eyecare technology company focused on creating innovative solutions intended to transform care and improve patients’ lives, today announced International Ophthalmology has published clinical data demonstrating the safety and effectiveness of the OMNI Surgical System as a minimally invasive, implant-free standalone (not in combination with cataract surgery) glaucoma procedure for pseudophakic glaucoma patients with a history of trabecular microbypass stent implantation (iStent® or iStent Inject®) whose pressure is no longer controlled by the bypass stent and IOP-lowering medications.

“Glaucoma is a chronic disease, and most patients will need a variety of treatments over the course of their lives. Compliance with daily glaucoma medications can be low, and depending on the patient and stage of disease progression, some interventions such as bypass stents and/or IOP-lowering medications may run their natural course and no longer control the disease,” said Deepan Selvadurai, MD, a glaucoma specialist and cataract surgeon at Buffalo Ophthalmology in Buffalo, New York, and a clinical investigator and co-author of the study. “The OMNI Surgical System offers a potent implant-free procedure that I have found to be effective and durable in my pseudophakic patients where I had previously implanted trabecular bypass stents at the time of cataract surgery. This study showed that canaloplasty followed by trabeculotomy with OMNI as a standalone procedure in pseudophakic eyes with stents was highly effective in reducing IOP.”

The OMNI Surgical System is an implant-free procedure that uniquely addresses all three known points of resistance in the aqueous outflow system: the trabecular meshwork, Schlemm’s canal, and the collector channels. Because it offers a comprehensive mechanism of action through sequential canaloplasty and trabeculotomy, OMNI surgeons can successfully intervene in the same conventional outflow pathway anatomy when trabecular bypass implants and medications are no longer able to control IOP.

“More than one million eyes have received trabecular microbypass stent implants. Over time, these patients may progress to the point where their IOP is no longer adequately controlled by the implant and/or IOP-lowering medications,” said Paul Badawi, CEO and co-founder of Sight Sciences. “Substantial data supports OMNI’s effectiveness in combination with cataract surgery as well as its standalone use. This important multi-center data shows that OMNI can also help our customers address this large, existing, and growing subset of pseudophakic stented glaucoma patients. We view this as additional validation that OMNI has the unique potential to provide benefit throughout the entire life cycle of glaucoma disease – performed before, during, and after cataract surgery.”

Authors and affiliations: Daniel C. Terveen MD, Adam R. Bleeker MD of Vance Thompson Vision, Steven R. Sarkisian Jr., MD of Oklahoma Eye Surgeons, Steven D. Vold MD of Vold Vision, Deepan Selvadurai MD of Buffalo Ophthalmology, Blake K. Williamson MD, The Williamson Eye Center, Deborah G. Ristvedt MD of Vance Thompson Vision, Kavita Dhamdhere Phd of Sight Sciences and Mahatma Gandhi Medical College, Jaime E. Dickerson Jr., PhD, of Sight Sciences and North Texas Eye Research Institute.

Paper Reference: Terveen, D.C., Sarkisian, S.R., Vold, S.D. et al. Canaloplasty and trabeculotomy with the OMNI® surgical system in OAG with prior trabecular microbypass stenting. Int Ophthalmol (2022). https://doi.org/10.1007/s10792-022-02553-6

iStent and iStent Inject are registered trademarks of Glaukos Corporation.

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.

For more information, visit www.OMNIsurgical.com.

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 SION™ Surgical Instrument is a bladeless, manually operated device used in ophthalmic surgical procedures to excise trabecular meshwork. 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.

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 – Glaucoma:
Carmen Caricchio
C2M Group
pr@sightsciences.com

Investor contact:
Philip Taylor
Gilmartin Group
415.937.5406
Investor.Relations@Sightsciences.com

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