Efficacy of the Three Most Commonly Used MIGS Technologies plus Cataract Surgery and Cataract Surgery Alone Were Evaluated and Compared in over 100,000 Glaucoma Patient Eyes
MENLO PARK, Calif., Oct. 03, 2023 (GLOBE NEWSWIRE) — Sight Sciences, Inc. (Nasdaq: SGHT) (“Sight Sciences”), an eyecare technology company focused on developing and commercializing innovative technology intended to transform care and improve patients’ lives, today announced the results of the large scale, comparative real-world clinical outcomes study of patients treated by three leading minimally invasive glaucoma surgery (“MIGS”) technologies, which were recently presented at the 41st Congress of the European Society of Cataract and Refractive Surgeons (“ESCRS”) in Vienna, Austria.
Using the American Academy of Ophthalmology (“Academy”) IRIS® Registry (“Intelligent Research in Sight”), the largest specialty society clinical data registry in all of medicine and the first comprehensive eye disease clinical registry in the United States, this large-scale MIGS study evaluated long-term 2-year post-surgical outcomes among patients with glaucoma treated with the three most commonly used FDA approved/cleared ab interno MIGS devices in the U.S. (OMNI Surgical System, Hydrus® Microstent, and iStent inject®) combined with cataract surgery, as well as for cataract surgery alone.
Trabeculocanalicular Outflow Restoration (“TCOR”) powered by OMNI Surgical System technology describes a unique implant-free, ab interno procedure that comprehensively addresses the three primary points of outflow resistance. OMNI technology has been cleared by the FDA for canaloplasty followed by trabeculotomy to reduce intraocular pressure in adult patients with primary open-angle glaucoma.
Baseline Patient Characteristics:
- The entire study cohort consisted of 77,391 glaucoma patients and 109,745 glaucomatous eyes
- 6,632 patients and 9,000 eyes received a MIGS procedure in combination with cataract surgery and the remainder received cataract surgery alone
- The full study patient population was homogenous. Each cohort at baseline had a similar mean intraocular pressure (“IOP”) and a similar mean number of IOP-lowering medications (see table below)
- The primary treatment goal for the high baseline IOP group was IOP reduction, with a secondary goal to reduce medication burden. The primary treatment goal for the low baseline IOP group was to reduce medication burden
| Baseline | Group 1 Pre-op
(> 18mmHg IOP Stratification) |
Group 2 Pre-op
(≤ 18mmHg IOP Stratification) |
||
| Mean IOP (mmHg) | Number of IOP-Lowering Medications | Mean IOP (mmHg) | Number of IOP-Lowering Medications | |
| TCOR using OMNI Surgical System | 22.5 | 1.95 | 14.1 | 2.01 |
| Hydrus Microstent | 22.5 | 1.89 | 14.2 | 1.89 |
| iStent inject | 22.2 | 1.58 | 14.4 | 1.58 |
| Cataract-Surgery Alone | 22.8 | 1.60 | 14.5 | 1.62 |
Clinical Outcomes:
- At 24 months, high baseline IOP (>18 mmHg) patients who received the TCOR procedure using OMNI technology had:
- the greatest numerical reduction in IOP, and
- the greatest numerical reduction in medication use
- At 24 months, low baseline IOP (≤18 mmHg) patients who received the TCOR procedure using OMNI technology had:
- the greatest numerical reduction in IOP, and
- a statistically significant greater mean medication reduction compared to all other treatment groups at 24 months
- Link to full presentation: https://ssi.onl/3PXM0He
|
Post Treatment |
Group 1 > 18mmHg IOP
Clinical Outcomes @ 24 Mo |
Group 2 ≤ 18mmHg IOP
Clinical Outcomes @ 24 Mo |
||
| Mean Reduction in IOP(mmHg) | Mean Medication Reduction | Mean Reduction in IOP(mmHg) | Mean Medication Reduction | |
| TCOR using OMNI Surgical System | -6.64 | -1.34 | -0.47 | -1.42 |
| Hydrus Microstent | -5.71 | -1.2 | +0.03 | -1.18 |
| iStent inject | -4.96 | -0.86 | -0.17 | -0.95 |
| Cataract-Surgery Alone | -5.55 | -0.67 | -0.07 | -0.65 |
“Given the global patient compliance challenges and eventual limitations inherent in topical IOP-lowering medications, the long-term reduction in both IOP and medication usage for mild, moderate, and severe glaucoma patients with the TCOR procedure using OMNI Surgical System technology is significant,” stated Dr. Andrew Tatham, consultant ophthalmic surgeon at Princess Alexandra Eye Pavilion, Edinburgh, Honorary Senior Lecturer at University of Edinburgh, and NHS Scotland Career Research Fellow. “Glaucoma is an around-the-clock disease. The value of TCOR is that it offers sustained IOP-control. This analysis shows meaningful differences in the clinical outcomes for the most commonly used minimally invasive glaucoma surgeries in the real-world setting on a large scale.”
“Many industry stakeholders have asked us how OMNI compares to other MIGS technologies in the real-world. To better understand the clinical value proposition of the most commonly used MIGS technologies, we collaborated with Verana Health® to leverage the IRIS Registry to create what we believe is the most comprehensive MIGS dataset ever assembled. Independent data from the IRIS Registry is valuable and we believe it will inform surgeons’ decision-making when considering the best treatment option for their glaucoma patients. We look forward to sharing this analysis and educating Medicare and healthcare insurers about the TCOR comprehensive MIGS procedure enabled by OMNI technology. Consistent with our many prior published peer-reviewed studies, the TCOR procedure delivers clinically meaningful and durable reductions in both intraocular pressure and medication use,” said Paul Badawi, co-founder and CEO of Sight Sciences.
“Our mission at Sight Sciences is to elevate the standard of care for patients by furnishing eye doctors with the best technology to improve patient outcomes. We believe that our two core technologies, OMNI and TearCare, clearly elevate the standard of care for the millions of patients suffering from glaucoma and dry eye disease,” continued Mr. Badawi. “I’d like to thank our dedicated employees for steadfastly delivering on our patient-centric mission as we help advance new treatment paradigms in glaucoma and dry eye disease. I’d also like to thank the team at Verana Health for partnering with the Academy to make the critical, real-world, large-scale, clinical outcome information in the IRIS Registry available for all stakeholders, including eyecare providers, industry, and researchers.”
About Sight Sciences
Sight Sciences is an eyecare technology company focused on developing and commercializing innovative solutions 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 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 Company’s TearCare® System technology 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”) when used in conjunction with manual expression of the meibomian glands, enabling office-based 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.
For more information, visit www.sightsciences.com.
OMNI, TearCare, and SION are registered trademarks of Sight Sciences, Inc.
TCOR is a trademark of Sight Sciences, Inc.
Hydrus is a registered trademark of Alcon Vision LLC.
iStent inject is a registered trademark of Glaukos Corporation.
IRIS is a registered trademark of the American Academy of Ophthalmology.
Verana Health is a registered trademark of Verana Health.
© 2023 Sight Sciences. All rights reserved.
About Verana Health
Verana Health® (Verana) is revolutionizing patient care and clinical research by unlocking the potential of real-world data. Verana has an exclusive real-world data network of 90 million de-identified patients from more than 20,000 clinicians, stemming from its exclusive data partnerships with three leading medical societies. Verana harnesses deep expertise, secure advanced technology, and direct access to exclusive, near real-time data sources to deliver actionable quality insights that help companies make sense of the data. For more information, visit www.veranahealth.com.
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, which statements are subject to considerable risks and uncertainties. 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 herein include, without limitation, statements concerning the perceived benefits of the IRIS Registry analysis in informing future conversations and decision-making when considering treatment options for glaucoma patients, and; the intent to share the IRIS Registry analysis with Medicare and healthcare insurers and to educate them about the TCOR comprehensive MIGS procedure enabled by OMNI technology. 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 management believes these forward-looking statements are based upon reasonable assumptions at the time they are made, management cannot guarantee their accuracy or completeness. Forward-looking statements are subject to and involve risks, uncertainties and assumptions that may cause the Company’s actual results, performance or achievements to be materially different from any future results, performance, or achievements predicted, assumed or implied by such forward-looking statements. Some of the risks and uncertainties that may cause actual results to materially differ from those expressed or implied by these forward-looking statements are discussed under the caption “Risk Factors” in the Company’s filings with the SEC, 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. Sight Sciences undertakes 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.
Investor contact:
Philip Taylor
Gilmartin Group
415.937.5406
Investor.Relations@Sightsciences.com
