Microinvasive Glaucoma Surgery with the OMNI® Surgical System is Associated with Diminished Diurnal IOP Fluctuations, a Significant, Independent Risk Factor for Glaucoma Progression
12-Month OMNI data from the prospective, multicenter GEMINI clinical trial show statistically significant postoperative reductions in mean IOP and suppression of daily IOP fluctuations
MENLO PARK, Calif., Nov. 17, 2021 (GLOBE NEWSWIRE) -- Sight Sciences, Inc. (Nasdaq: SGHT), an eyecare technology company focused on creating innovative solutions intended to transform standards of care and improve patients’ lives, today announced publication in Clinical Ophthalmology of favorable data showing that microinvasive glaucoma surgery (MIGS) using the OMNI® Surgical System suppressed daily fluctuations in intraocular pressure (IOP) – a meaningful and independent risk factor for the progression of glaucoma.
OMNI is cleared by the U.S. Food and Drug Administration (FDA) and CE-Marked for canaloplasty followed by trabeculotomy to reduce IOP in adult patients with primary open-angle glaucoma (POAG) (FDA) and open-angle glaucoma (CE).* Sight Sciences intends to further develop OMNI and seek regulatory clearance for expanded indications.
The importance of IOP reduction to limit or halt disease progression is well known and has been demonstrated in landmark studies such as the Advanced Glaucoma Intervention Study (AGIS) and the Early Manifest Glaucoma Trial (EMGT). The importance of daily IOP fluctuation in glaucoma progression is also generally accepted. Results from the GEMINI study showed that MIGS using the OMNI Surgical System resulted in a significant reduction in overall mean IOP from baseline, and in a post hoc analysis, a reduction in the variation and amplitude of mean IOP was observed at each diurnal time point evaluated. In the study, 95% of patients had a diminished peak IOP postoperatively when compared to preoperative measurements. The difference between “high” and “low” IOP at 12 months reduced an average of 36% compared to preoperative measurements.
“Post hoc analysis of the GEMINI data suggests that ab-interno canaloplasty plus goniotomy using the OMNI Surgical System combined with cataract surgery has the potential to control IOP fluctuations, a known risk factor for the progression of glaucoma,” said Mark F. Pyfer, M.D., Northern Ophthalmic Associates, Jenkintown, Pa., GEMINI investigator and first author of the study. “We observed that when many of our GEMINI study patients returned for 12-month diurnal IOP monitoring off all medications, their IOP appeared stable throughout the day. This observation motivated our post hoc analysis of the GEMINI study data, showing that the 12-month variability of patients’ IOP measurements decreased significantly from preoperative levels, essentially “flattening” the diurnal curve during the daytime.”
The GEMINI study was a prospective, 12-month, multicenter study of the effectiveness and safety of the OMNI Surgical System used in combination with cataract surgery in patients with mild to moderate open-angle glaucoma. The study enrolled 149 patients across 15 centers in the U.S., with 15 participating surgeons. Patients were “washed out” of their pre-study IOP-lowering medications before surgery, and again at the 12-month endpoint, to ensure study results were not confounded by medication use.
“We believe this post hoc analysis of the GEMINI study is meaningful because it shows that OMNI not only lowers IOP by addressing all three points of resistance in the conventional pathway (trabecular meshwork, Schlemm’s canal, distal collector channels), but treatment with OMNI also decreased the magnitude of daily IOP fluctuations, known to be a significant and independent risk factor for disease progression,” said Paul Badawi, Co-Founder and CEO, Sight Sciences. “OMNI uniquely enables clinicians to perform canaloplasty followed by trabeculotomy and address all three points of resistance in the diseased conventional outflow pathway with a single device through a single clear corneal microincision. We believe, with this post hoc analysis, we are the first company to observe a ‘flattened diurnal curve,’ an important clinical finding that further supports OMNI’s differentiated clinical outcomes and our forward-thinking leadership in the MIGS category.”
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.
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. 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 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 31 global patents.
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 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.