MENLO PARK, Calif., Aug. 24, 2021 (GLOBE NEWSWIRE) — Sight Sciences, Inc. (Nasdaq: SGHT), a growth-stage medical device company focused on developing and commercializing devices designed to address the underlying causes of the world’s most prevalent eye diseases, today announced publication in Clinical Ophthalhmology of favorable 24-month outcomes from a single center open-label study of the OMNI® Surgical System conducted in Germany.
OMNI is cleared by the U.S. Food and Drug Administration (FDA) and CE-Marked for canaloplasty followed by trabeculotomy to reduce intraocular pressure (IOP) in adult patients with primary open-angle glaucoma (POAG) (FDA) and open-angle glaucoma (CE).* Sight Sciences intends to further develop OMNI, and to seek regulatory clearance, for expanded indications.
Results from the study, conducted and co-authored by Karsten Klabe, M.D. and Hakan Kaymak, M.D., report that use of OMNI to perform a standalone MIGS procedure (not combined with cataract surgery) in mild to moderate open-angle glaucoma resulted in statistically significant reductions in both IOP and IOP-lowering medication use at 24 months. The study included long-term (24-month) outcomes from 38 eyes of 27 subjects with open-angle glaucoma. First author, Dr. Klabe, directly performed canaloplasty followed by trabeculotomy on each patient using OMNI at his practice in Düsseldorf, Germany.
Mean baseline IOP in the study decreased from 24.6 mmHg preoperatively to 14.7 and 14.9 mmHg at months 12 and 24, respectively, reductions of approximately 10 mmHg or approximately 40%. All subjects in the study, and 100% of eyes, had at least a 20% IOP reduction at 24 months. Mean baseline IOP-lowering medication also decreased from 1.9 average medications per patient to 0.5 medications at month 24. At 24 months, nearly 60% of eyes were free of IOP-lowering medication. Both IOP and IOP-lowering medication reduction outcomes in the study were statistically significant (p<.0001). Importantly, the study cohort included primary open-angle glaucoma (71%) and pseudoexfoliation glaucoma (29%) patients, as well as phakic (74%) and pseudophakic (eye with an intraocular lens; 26%) eyes. Outcomes for these subgroups were observed to be similar to the overall results. Adverse events were observed to be consistent with those expected in angle or minimally invasive glaucoma surgery (MIGS). The most frequent was transient postoperative hyphema (17 eyes, 44%), in all cases 1 mm or less. Other adverse events included choroidal effusion (three eyes, 7.9%), anterior synechiae (two eyes, 5.3%), and transient lens-cornea touch associated with shallow anterior chamber (seen in one eye). All of these events were reported to have resolved spontaneously without intervention and with no sequelae. No secondary procedures were required to address adverse events. “These results are particularly meaningful because they support the long-term benefits of OMNI for use in a standalone procedure, regardless of lens status, to reduce IOP and the burden of medication in adult patients with POAG,” said Paul Badawi, Co-Founder and CEO, Sight Sciences. “We believe that OMNI uniquely enables clinicians to perform two implant-free procedures to address all three points of resistance in the diseased conventional outflow pathway with a single device through a single clear corneal microincision. We believe that these results may support OMNI’s potential for expanded indications in other glaucoma patient populations.” “By comprehensively addressing the entire conventional outflow pathway circumferentially with OMNI, clinicians can address outflow resistance wherever it occurs,” said Dr. Klabe. “OMNI offers clinicians a safe, effective and minimally invasive option for treating both phakic and pseudophakic patients outside of cataract surgery. I’m excited to see these outcomes further validate my clinical experience and success using OMNI on a standalone basis.” 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 currently markets two products, the OMNI® Surgical System and the TearCare® System. For more information, visit www.sightsciences.com.
About OMNI® Surgical System
The OMNI® Surgical System is a handheld, single use therapeutic device for minimally invasive glaucoma surgery (MIGS). OMNI allows surgeons to access 360 degrees and all three primary points of resistance of an eye’s diseased conventional outflow pathway (trabecular meshwork, Schlemm’s canal, and collector channels) through a single clear corneal microincision.
*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 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® is a registered trademark of Sight Sciences.
© 2021 Sight Sciences. All rights reserved.
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 or during the earnings call 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”); and 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.