- Suppression of diurnal, or daily, fluctuations in IOP, is a significant and independent risk factor for the progression of glaucoma
- These 12-month outcomes were also confirmed by results from a subset of the study, assessing the Hispanic patient population
MENLO PARK, Calif., May 31, 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 publication in Clinical Ophthalmology of its 12-month outcomes in the GEMINI study, including results from a Hispanic population subset. The final study results demonstrated that canaloplasty and trabeculotomy performed as an implant-free minimally invasive glaucoma surgery (MIGS) using the OMNI® Surgical System in conjunction with cataract surgery significantly reduced unmedicated mean diurnal intraocular pressure (IOP), medication use and daily fluctuations in IOP in patients with open-angle glaucoma (OAG).
The GEMINI study exhibited a mean unmedicated diurnal IOP reduction of 35%, from 23.8 (3.1) mmHg at baseline to 15.6 (4.0) at month 12 and a medication reduction (before washout) of 80% from 1.8 (0.9) at baseline to 0.4 (0.9) at month 12. At month 12, 84.2% of eyes achieved IOP reductions > 20% from baseline, 80% of eyes were medication-free, and 76% of eyes achieved IOP between 6– 18 mmHg, inclusive. 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. Suppression of diurnal, or daily, fluctuations in IOP, is a significant and independent risk factor for the progression of glaucoma.
In the Hispanic population subset of the GEMINI study, the unmedicated mean diurnal IOP was reduced from 22.8 mmHg (2.5) to 14.9 (3.6) at 12 months – also a 35% reduction, as with the larger study. Data show that 97% of patients had an IOP reduction, and 85% had ≥20% reduction. At month 12, medications were reduced from 0.43 to 0.15 (P<0.001) and the majority (87%) of patients required no medications. As the Hispanic population is the second largest racial or ethnic demographic in the U.S.1, with a higher predisposition to glaucoma2, this published data provides visibility of results from MIGS, specifically the OMNI Surgical System, that corroborate the larger study findings while providing specific data for the Hispanic population, which has been limited up to this point.
“Effective treatment backed by robust clinical evidence is critical for eyecare professionals who treat patients with glaucoma. We now have 12 months of prospective, multicenter data showing 360° canaloplasty and 180° trabeculotomy performed with the OMNI Surgical System at the time of cataract surgery significantly reduced unmedicated mean diurnal IOP and medication use at 12 months postoperatively,” said Mark J. Gallardo, MD, El Paso Eye Surgeons. “This conclusion was also observed in the Hispanic population, where there’s increased prevalence of glaucoma with a higher proportion who are undiagnosed. These results are particularly encouraging for eye care professionals and their patients who are ultimately all looking for a treatment option that may reduce the medication burden and offer sustained results.”
The GEMINI study was a prospective, 12-month, multicenter study to measure 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. The Hispanic (Northern Mexico/mestizo) open-angle glaucoma population encompassed 39 subjects from a tertiary referral glaucoma center in El Paso, Texas. The study had an excellent safety profile and no serious adverse events.
"The GEMINI study is yet another testament to the safety, efficacy, and durability of our micro-invasive, implant-free OMNI procedure. By circumferentially and comprehensively addressing all three points of resistance in the conventional outflow pathway, OMNI is redefining MIGS and elevating the clinical expectations within the category," said Paul Badawi, Co-Founder and CEO, Sight Sciences. "Sight Sciences is committed to providing the eyecare professional community and the patients they serve with solutions to help limit the progression of glaucoma, the world's leading cause of irreversible blindess.3”
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 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:
Shay Smith
Health+Commerce
707.971.9779
shay@healthandcommerce.com
Investor contact:
Philip Taylor
Gilmartin Group
415.937.5406
Investor.Relations@Sightsciences.com
- Noe-Bustamante, Luis, et al. “U.S. Hispanic Population Surpassed 60 Million in 2019, but Growth Has Slowed.” Pew Research Center, Pew Research Center, 2020
- Varma R, Ying-Lai M, Francis BA, et al. Prevalence of open-angle glaucoma and ocular hypertension in Latinos: the Los Angeles Latino Eye Study. Ophthalmology. 2004
- Centers for Disease Control and Prevention. 2020
