Glaucoma, Neovascular

TYLER, Texas , June 21, 2023 /PRNewswire/ -- The Bethesda Health Clinic, a nonprofit organization that provides healthcare services to the uninsured and underinsured residents of the Tyler East Texas community, successfully implemented AEYE-DS, an autonomous diabetic retinopathy screening solution developed by AEYE Health, to provide free diabetic retinopathy screenings to its patients. AEYE-DS uses FDA-cleared AI technology to provide instant diagnostic results instead of referring patients to a specialist. The screening procedure takes less than two minutes to perform and rarely requires dilation. Local retinal specialist Dr. Ming Lu and the Bethesda Health Clinic initiated this program to evaluate both the logistical implications and health benefits that AI-based diabetic eye exams can have on this specific patient population. A total of 126 patients were screened over the course of the three-week program, with 19 (15%) found positive for referable diabetic retinopathy. Retinal images were obtained using the Topcon NW400, a non-mydriatic, fully automated retinal camera. Images were uploaded to AEYE-DS and a diagnostic result was provided on the spot. A PDF report with the result was printed out and provided to patients along with recommendations for a follow-up screening in 12 months or a referral to an eye specialist for further treatment. The screening procedure does not require a doctor to perform or interpret. Following basic training, clinic staff were able to operate the retinal camera and upload images to the AI system for analysis. Some patients were scheduled for screening due to open care gaps, while others underwent screening while awaiting their doctor's appointment. "I am excited by the idea that AI can make healthcare more accessible to underserved communities. As a retina specialist, I am a big advocate of AI technology taking over the task of screening patients. This will allow me to spend more time with patients that actually need my expertise in treating their disease, rather than screening many patients, most of which do not need treatment," said Dr. Ming Lu, the chief of ophthalmology at Christus Trinity Clinic Eye Center in Tyler who sponsored the pilot project at The Bethesda Health Clinic. "I was amazed to see that most patients could get a reading in 1 to 2 minutes. The outcomes of this pilot are fantastic and I hope to leverage them to secure funding to permanently deploy the technology at The Bethesda Health Clinic and also at Christus Health." "We are very pleased to see another successful implementation of our unique solution, and that our efforts to develop a practical solution that can perform screenings quickly and accurately are paying off." said Zack Dvey-Aharon, Ph.D., Founder & CEO of AEYE Health. About The Bethesda Health Clinic The Bethesda Health Clinic is a nonprofit organization dedicated to providing healthcare services to the uninsured and underinsured in the Tyler community. The clinic offers a range of healthcare services, including primary care, chronic disease management, preventive care, mental health services, women's health, and limited dental services. The clinic relies heavily on the support of volunteer healthcare professionals, including physicians, nurses, and other medical staff, who generously donate their time and expertise to serve patients. The Bethesda Health Clinic is supported by community donations, grants, and partnerships with local healthcare providers and organizations to help fulfill their mission. About AEYE Health AEYE Health is a technology company specializing in the development of AI solutions for diagnosing a broad range of diseases using retinal images. Its screening solution for diabetic retinopathy is FDA-cleared in 2022 and designed to allow primary care providers to perform diabetic eye exams in their clinics instead of referring to specialists. About Dr. Ming Lu Dr. Lu is a magna cum laude graduate from Harvard Medical School, a retina specialist and chief of ophthalmology at Christus Trinity Clinic Eye Center in Tyler, Texas. He sponsored the free screening for diabetic retinopathy at the Bethesda Clinic. In 1994 Dr. Lu proposed the VEGF hypothesis for diabetic retinopathy after learning the concept of tumor angiogenesis as a medical student, in hope for a restorative treatment of the bleeding retina rather than the conventional destructive laser therapy. After sleeping with experimental animals for 5 years, Dr. Lu won the Nesmith Award from Schepens International Society in 1999 for his discovery of the central role of VEGF in diabetic retinopathy, providing the scientific basis for anti-VEGF therapy. Since 2004 anti-VEGFs such as Avastin, Lucentis, Eylea, and Vabysmo have become the mainstay treatment for retinopathy due to diabetes, macular degeneration, vascular occlusions, neovascular glaucoma and prematurity, much more effective than the traditional laser burns. Since 2010 he has championed the free digital screening and AI-based screening of diabetic retinopathy at all 89 Christus Trinity Clinic satellites (47,380 diabetic patients), improving the screening rate from 27% in remote East Texas 13 years ago to 61% now. CONTACT: Amit Wohl [email protected] SOURCE AEYE Health

Retrospective Clinical Data from Seven US Sites Published in Clinical Ophthalmology Sustained and clinically meaningful IOP reductions observed at 12 months persisted through 24 months Sustained and clinically meaningful reductions in glaucoma medication use observed at 12 months also persisted through 24 months Confirmed safety and efficacy of OMNI Surgical System technology in both standalone and combination cataract procedures Longest published multicenter clinical results of OMNI Surgical System to date MENLO PARK, Calif., May 23, 2023 (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 the publication of two-year results of the ROMEO (Retrospective, Observational, Multicenter, Evaluation of OMNI) study in Clinical Ophthalmology. The longest multicenter study of the OMNI® Surgical System technology to date in both standalone and combination-cataract surgery demonstrated that the significant reductions in IOP and medication usage observed at 12 months were also witnessed at 24 months. In addition, there were no serious or unanticipated adverse events during the length of the two-year study. "This longer-term data set representing patients treated at multiple centers throughout the country both at the time of cataract surgery and as a standalone treatment should give eye surgeons even greater confidence about the safety and durability of efficacy of the OMNI Surgical System technology," said Blake Williamson, MD, of The Williamson Eye Center in Baton Rouge, LA, and a principal investigator of the study. "Knowing that OMNI maintains effectiveness through two-years, and beyond, is very reassuring, not only to me, but also to my patients." Sites participating in this extension study accounted for 86 percent of eyes enrolled in the original ROMEO study from seven multi-specialty ophthalmology practices in six states (Arkansas, California, Kansas, Louisiana, Missouri, and New York). Patients with mild-moderate glaucoma received outflow restorative procedures enabled with the OMNI Surgical System technology either at the time of cataract surgery (n = 43) or as a standalone treatment (n = 29). Patients were divided into high baseline IOP (pre-operative IOP > 18 mmHg, n = 34) and low baseline IOP cohorts (pre-operative IOP ≤ 18 mmHg, n = 38). Average IOP in the high baseline IOP cohort fell 31% (from 21.9 mmHg to 15.2 mmHg) at two years, which included an average reduction of 28% among combination cataract patients (n = 17) and an average reduction of 33% among standalone patients (n = 17). The study also observed a 33% reduction in medication usage on average among all patients at 24 months. "This newest two-year follow-up data from the ROMEO study demonstrates that restorative outflow procedures with our OMNI technology continue to provide consistent and long-term lowering of IOP and glaucoma medication use when performed at the time of cataract surgery and as a standalone treatment," said Paul Badawi, co-founder and CEO of Sight Sciences. "We plan to share additional clinical data that will further illustrate the long-term benefits of our OMNI technology over the coming years." The OMNI Surgical System enables surgeons to provide minimally invasive, implant-free surgery to reduce intraocular pressure (IOP) in adults with primary open-angle glaucoma. The procedure intends to restore outflow by targeting all three known points of resistance in the aqueous outflow system: the trabecular meshwork, Schlemm's canal, and the collector channels. It can be used before, in combination with, or following cataract surgery. The study, Canaloplasty and Trabeculotomy with the OMNI System in Patients with Open-Angle Glaucoma: Two-Year Results from the ROMEO Study, was published this month in Clinical Ophthalmology can be found at . 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) technology 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. In addition, the Company's TearCare® System technology 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. Visit SightSciences.com for more information. About the OMNI Surgical System The OMNI® Surgical System technology is a handheld, single-use therapeutic device for minimally invasive glaucoma surgery (MIGS). OMNI allows surgeons to access 360 degrees and 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's FDA-cleared indication is 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 technology is protected by a global patent portfolio including 32 issued patents worldwide. OMNI is a registered trademark of Sight Sciences. Visit for more information. © 2023 Sight Sciences. All rights reserved. Media contact - Glaucoma Carmen Caricchio C2M Group pr@SightSciences.com Investor contact Philip Taylor Gilmartin Group 415.937.5406 Investor.Relations@Sightsciences.com

The Ergo-Series maximizes ergonomics and surgical ease-of-use while continuing to enable surgeons to perform minimally invasive, implant-free glaucoma procedures MENLO PARK, Calif., March 09, 2023 (GLOBE NEWSWIRE) -- Sight Sciences, Inc. (Nasdaq: SGHT), an eyecare technology company focused on developing and commercializing innovative technology that provides solutions intended to transform care and improve patients' lives, today announced the United States launch of the Ergo-Series of the OMNI® Surgical System, a technology that facilitates surgeons’ ability to perform minimally invasive, implant-free glaucoma procedures in adults with primary open-angle glaucoma. The OMNI Surgical System enables a minimally invasive glaucoma surgery (MIGS) that addresses all three known points of resistance in the aqueous outflow system: the trabecular meshwork, Schlemm’s canal, and the collector channels. It can be used before, in combination with, or following cataract surgery. The new features of the Ergo-Series include: Improved Handle Ergonomics: New enhancements enable surgeons to more easily rotate and position the cannula tip within Schlemm’s canal with precise finger rotations versus wrist adjustments. Simplified Viscoelastic Preparation: The handle’s viscoelastic luer connector is now removable and detaches when the viscoelastic cartridge is removed, resulting in more clearance with the surgical microscope. New Cannula Tip Design: The Ergo-Series cannula tip has a new pro enables gentle and precise access to Schlemm's canal while continuing to enable full 360-degree catheterization associated with the OMNI procedure. Reay Brown, MD, a Glaucoma Specialist and Sight Science's Chief Medical Officer, said "The Ergo-Series maintains the same therapeutic functionality as the second-generation OMNI Surgical System. The technology enhancements provide additional benefits that enable surgeons to perform an innovative, minimally invasive glaucoma surgery." “For me, the new cannula tip technology is the biggest improvement,” said Zarmeena Vendal, MD, glaucoma surgeon and founder of Westlake Eye Specialists in Austin, Texas. “The pro the tip enables me to score the trabecular meshwork more confidently and makes entry into Schlemm’s canal gentler. In addition, when I deploy the catheter, I can follow the path of the Schlemm’s canal a bit more naturally. In our glaucoma surgery practice, access to the OMNI Surgical System lets us provide these new technology procedures for the benefit of our patients.” OMNI Surgical System, Ergo-Series enables surgeons to provide a minimally invasive, implant-free surgery to reduce intraocular pressure (IOP) in adults with primary open-angle glaucoma. The device’s indications for use, contraindications, warning, and precautions remain unchanged. The OMNI Surgical System is indicated for canaloplasty (microcatheterization and transluminal viscodilation of Schlemm’s canal) followed by trabeculotomy (cutting of trabecular meshwork) to reduce intraocular pressure in adult patients with primary open-angle glaucoma. It can be used before, in combination with, or following cataract surgery. Paul Badawi, CEO and co-founder of Sight Sciences, added, “OMNI is an innovative technology developed to enable a surgeon to perform a circumferential and complete outflow procedure that addresses all three known points of resistance in the aqueous outflow system through a single clear corneal incision. We are committed to continually innovating and improving our core technologies alongside our surgeon partners in order to provide the greatest benefit to patients suffering from primary open-angle glaucoma. Based on the initial feedback, we are confident the Ergo-Series of the OMNI Surgical System will continue to raise the bar.” The Ergo-Series of the OMNI Surgical System is expected to be available outside the United States later this year. 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 SightSciences.com. About the OMNI Surgical System The OMNI® Surgical System technology consists of a handheld, single-use therapeutic device for minimally invasive glaucoma surgery (MIGS). OMNI allows surgeons to access 360 degrees and 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's FDA-cleared indication is 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 technology is protected by a global patent portfolio including 32 issued patents worldwide. For more information, visit 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 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; execution of our market strategies; 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 Carmen Caricchio C2M Group pr@SightSciences.com Investor contact Philip Taylor Gilmartin Group 415.937.5406 Investor.Relations@Sightsciences.com © 2023 Sight Sciences. All rights reserved. Dr. Vendal is a paid consultant of Sight Sciences. OMNI and SION are trademarks or registered trademarks of Sight Sciences. 02/2023 OM-2790-US.v1 A photo accompanying this announcement is available at: Ergo-Series of the OMNI® Surgical System by Sight Sciences, Inc. The Ergo-Series maximizes ergonomics and surgical ease-of-use while continuing to enable surgeons to perform minimally invasive, implant-free glaucoma procedures