Sight Sciences Announces the Results of the Three-Year Prospective GEMINI Trial and the Cross-Over Phase of the SAHARA RCT at the 2024 American Society of Cataract and Refractive Surgery (ASCRS) Annual Meeting
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Insights
From a clinical standpoint, the OMNI Surgical System's 36-month outcomes are noteworthy. The longevity of efficacy post-surgery is a critical factor in the management of primary open-angle glaucoma (POAG), which is a chronic condition requiring long-term treatment strategies. The sustained reduction in intraocular pressure (IOP) and medication use over a three-year period post-OMNI procedure, as indicated by the extended Gemini Study, suggests a potential shift in the treatment paradigm for POAG. This could lead to a decrease in the reliance on long-term medication, which often comes with compliance challenges and side effects. Additionally, the minimally invasive nature of the procedure aligns with the current trend towards less invasive surgical interventions, which can result in reduced recovery times and complications.
The presentation of these long-term clinical results at a high-profile event like the ASCRS Annual Meeting is likely to have a positive impact on the market perception of Sight Sciences. The data could strengthen the company's position in the ophthalmic device market, potentially influencing stock performance favorably. Investors often look for companies with a robust pipeline of evidence-backed products and the OMNI and TearCare systems appear to be differentiating themselves in a competitive space. The additional data could also aid in marketing efforts, as strong, long-term results are compelling for both clinicians and patients when considering treatment options. Furthermore, the focus on TearCare as a primary treatment for dry eye disease (DED) taps into a large patient population, expanding the potential market reach and revenue streams for Sight Sciences.
The positive clinical outcomes for both OMNI and TearCare technologies highlighted in these presentations are significant from a regulatory perspective. Demonstrating long-term efficacy and safety is important for maintaining and expanding regulatory approvals, which can directly affect market access and insurance coverage. The emphasis on TearCare as a primary treatment for DED, a condition often managed with pharmaceuticals, could lead to an expanded indication for the device. This would be a strategic win for Sight Sciences, potentially broadening its user base and increasing its competitive edge. Moreover, the ability of TearCare to show improvement in symptoms for patients already treated with cyclosporine suggests that it could be positioned as an adjunctive or alternative therapy, offering additional treatment options for clinicians and patients.
Clinical results demonstrate long-term efficacy of the OMNI® Surgical System for primary open-angle glaucoma and support use of TearCare® technology as a primary treatment for dry eye disease.
MENLO PARK, Calif., April 02, 2024 (GLOBE NEWSWIRE) -- Sight Sciences, Inc. (Nasdaq: SGHT), an eyecare technology company focused on developing and commercializing innovative, interventional technologies intended to transform care and improve patients’ lives, announced today that data from studies of two of its proprietary glaucoma and dry eye technologies, the OMNI Surgical System (“OMNI”) and the TearCare System (“TearCare”), will be presented in two oral presentations and two posters at this year’s ASCRS Annual meeting April 5th to 8th in Boston, MA.
OMNI technology facilitates surgeons’ ability to perform a comprehensive, implant-free, minimally invasive glaucoma surgical procedure in adults with primary open-angle glaucoma (“POAG”). TearCare technology enables a proprietary, interventional eyelid procedure for diseased meibomian glands and is intended for the application of localized heat therapy in adult patients with evaporative dry eye disease (“DED”) due to meibomian gland dysfunction, when used in conjunction with manual expression of the meibomian glands.
“We are excited that additional data supporting the efficacy and safety of our OMNI and TearCare technologies will be presented at ASCRS, the largest annual gathering for anterior segment surgeons,” said Paul Badawi, CEO and co-founder of Sight Sciences. “In addition to our existing robust body of clinical evidence, we now have additional data showing impressive OMNI results at 36-months, which demonstrate the vital long-term element of OMNI’s efficacy. We are also pleased that new TearCare data will be shared that supports the use of TearCare technology as a primary treatment for DED.”
Oral Presentation: OMNI Surgical System
- 36-Month Outcomes for Canaloplasty and Trabeculotomy Combined with Cataract Surgery: Extended Follow-up from the Gemini Study – oral presentation on Sunday, April 7th at 3:50 PM ET at the BCEC Meeting level 2 room 259A. Lead author: Arkadiy Yadgarov, MD
“Long-term data is key in the selection of a surgical treatment,” said Arkadiy Yadgarov, MD, of Omni Eye Services of Atlanta, GA. “The 12-month GEMINI trial demonstrated efficacy of the OMNI procedure combined with cataract surgery for IOP and medication reduction in mild-to-moderate glaucoma.1,2 This extension of the trial shows that these positive 12-month outcomes were sustained through 36 months.”
Oral and Paper Presentations: TearCare System
- Tear Break-up, Meibomian Gland, and Dry Eye Symptom Improvement for Cyclosporine-Treated Patients after Localized Heat Therapy Treatment (SAHARA Cross-Over/phase 2) – oral presentation on Sunday, April 7 at 3:30 PM ET at the BCEC Meeting level 2, room 259B. Lead author: Brandon Ayres, MD
- Rapid Improvement in the Signs and Symptoms of Dry Eye Disease with Localized Heat Therapy (LHT) or Cyclosporine Ophthalmic Emulsion (CsA) (SAHARA subanalysis) – poster presentation. Lead author: Julio Echegoyen, MD, PhD
- Localized Heat Therapy (LHT) Compared to Cyclosporine Ophthalmic Emulsion (CsA): A Subanalysis on Age, Gender, and Disease Burden (SAHARA subanalysis) – poster presentation. Lead author: Jennifer Loh, MD
“These data once again support the conclusion that TearCare should be a preferred treatment for DED associated with meibomian gland dysfunction,” says Brandon Ayres, MD, of Wills Eye Hospital, Philadelphia, PA. “In phase 1 of the SAHARA trial, we found the interventional TearCare procedure provided statistically superior and sustained improvement in tear break-up time and multiple measures of meibomian gland secretion when compared to treatment with Restasis.3 In phase 2 (cross-over) of the study, we found that a single TearCare procedure improved signs and symptoms for patients beyond what was achieved with six months of Restasis.”
Red Carpet Event
Additionally, at ASCRS, Sight Sciences will be hosting a red carpet event at its booth (#545), where the company will celebrate its shared commitment to elevating eyecare for the benefit of patients. The event will be on Saturday, April 6, 2024, from 3:45 PM to 4:30 PM ET. Learn more about this and other Sight Sciences activities at ASCRS at www.sightsciences.com/ascrs
About Sight Sciences
Sight Sciences is an eyecare technology company focused on developing and commercializing innovative and interventional 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 an implant-free glaucoma surgery technology (i) indicated in the United States to reduce intraocular pressure in adult patients with primary open-angle glaucoma; and (ii) CE Marked for the catheterization and transluminal viscodilation of Schlemm’s canal and cutting of the trabecular meshwork to reduce intraocular pressure in adult patients with open-angle glaucoma. Glaucoma is 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 clearance of gland obstructions by physicians to address the leading cause of dry eye disease. The Company’s SION® Surgical Instrument is a manually operated device used in ophthalmic surgical procedures to excise trabecular meshwork. Visit sightsciences.com for more information.
Sight Sciences and TearCare are trademarks of Sight Sciences registered in the United States. OMNI and SION are trademarks of Sight Sciences registered in the United States, European Union and other territories. Restasis is a registered trademark of Allergan, an AbbVie company.
All educational content of the ASCRS Annual Meeting is planned by its program committee, and ASCRS does not endorse, promote, approve, or recommend the use of any products, devices, or services.
© 2024 Sight Sciences. All rights reserved. 04/2024 SS-3165-US.v1
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 timing for presentation of OMNI and TearCare-related clinical trial results and use of TearCare as a preferred treatment for DED associated with meibomian gland dysfunction. 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 forward-looking statements are subject to and involve numerous risks, uncertainties and assumptions, including those 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, and you should not place undue reliance on these statements. These cautionary statements 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.
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1. Gallardo MJ, Pyfer MF, Vold SD, et al. Canaloplasty and Trabeculotomy Combined with Phacoemulsification for Glaucoma: 12-Month Results of the GEMINI Study. Clin Ophthalmol. 2022;16:1225-1234. Published 2022 Apr 21. doi:10.2147/OPTH.S362932
2. Greenwood MD, Yadgarov A, Flowers BE, et al. 36-Month Outcomes from the Prospective GEMINI Study: Canaloplasty and Trabeculotomy Combined with Cataract Surgery for Patients with Primary Open-Angle Glaucoma. Clin Ophthalmol. 2023;17:3817-3824. Published 2023 Dec 12. doi:10.2147/OPTH.S446486
3. Ayres BD, Bloomenstein MR, Loh J, et al. A Randomized, Controlled Trial Comparing Tearcare® and Cyclosporine Ophthalmic Emulsion for the Treatment of Dry Eye Disease (SAHARA). Clin Ophthalmol. 2023;17:3925-3940. Published 2023 Dec 18. doi:10.2147/OPTH.S442971
FAQ
What technologies were highlighted in the press release by Sight Sciences, Inc. (Nasdaq: SGHT)?
Where will the data from studies of the OMNI Surgical System and TearCare System be presented?
What is the purpose of the OMNI Surgical System in relation to primary open-angle glaucoma?
What is the intended application of the TearCare System for dry eye disease?
When will the oral presentation on the OMNI Surgical System 36-Month Outcomes be held?
