Sight Sciences Announces Publication of a New Analysis from The ROMEO Study Showing Meaningful Pressure and Medication Reductions Achieved with OMNI® Across Mild, Moderate, and Advanced Glaucoma
Sight Sciences (Nasdaq: SGHT) announced the findings from a new analysis of the ROMEO study, which suggests that their OMNI Surgical System is effective in lowering intraocular pressure (IOP) and reducing medication usage in patients with glaucoma, regardless of disease severity. The study, published in Clinical Ophthalmology, included 129 patients categorized by glaucoma severity (mild, moderate, advanced) and showed significant reductions in IOP and medication usage at 12 months post-treatment. The majority of eyes (70%) saw IOP reduction, with 92% achieving 18 mmHg or less. Additionally, 50% to 69% of patients reduced medication usage by at least one medication. The findings challenge the belief that advanced glaucoma cannot be effectively treated with minimally invasive glaucoma surgery (MIGS) and suggest consistent treatment outcomes across all stages of the disease.
- Significant IOP reduction observed in 70% of eyes by Month 12.
- 92% of patients achieved IOP levels of 18 mmHg or less.
- Consistent IOP reduction across mild, moderate, and advanced glaucoma groups.
- 50% to 69% of patients reduced medication usage by at least one medication.
- No significant relationship between month 12 IOP and visual field loss, indicating consistent outcomes regardless of disease severity.
- OMNI technology demonstrated a strong safety profile and proven durability.
- The study sample for advanced glaucoma was small (only 6 patients), which might affect the generalizability of the results.
- The analysis was retrospective, which might introduce biases and limit the strength of the conclusions.
- Longer-term efficacy and safety data are not provided, potentially limiting the understanding of OMNI's long-term performance.
Insights
The findings from the ROMEO study could be significant for the field of ophthalmology, especially for those treating glaucoma. The data suggests that the OMNI Surgical System is able to effectively lower intraocular pressure (IOP) and reduce the need for medication across all stages of glaucoma, including advanced stages. This challenges the current belief that patients with advanced glaucoma may not benefit as much from minimally invasive glaucoma surgery (MIGS) due to potential irreversible damage to outflow pathways. The results confirm that the OMNI system can address all three areas of outflow resistance, providing a balanced and comprehensive approach to treating glaucoma. For patients, these findings could lead to broader adoption of this procedure, particularly for those who are in advanced stages and have limited treatment options.
From a financial perspective, the positive outcomes of the ROMEO study could have a considerable impact on Sight Sciences' market position and revenue growth. Currently, the company is trading under the ticker SGHT. The new data enhances the value proposition of the OMNI system, potentially increasing its adoption among ophthalmologists and securing more FDA approvals for various stages of glaucoma treatment. This could translate to higher sales and a stronger market presence. Investors should note the current price trends and volume of SGHT stocks, as positive clinical outcomes often lead to increased investor confidence and stock price appreciation. However, the long-term impact will depend on the company's ability to effectively market the OMNI system and navigate any competitive landscape in the ophthalmology device market.
From a market perspective, the advancement in the OMNI Surgical System's efficacy across different stages of glaucoma could significantly influence the positioning of Sight Sciences within the eyecare technology market. The ability to treat advanced glaucoma effectively opens up a new segment of the market that was previously underserved. This could lead to increased market share and potentially disrupt existing treatment paradigms. For retail investors, understanding the competitive landscape is crucial. Competitors in the MIGS space, such as Glaukos and Alcon, might face increased competition, prompting a reevaluation of their own product offerings and strategies. This could lead to a dynamic shift in market dynamics and possibly result in partnerships, mergers, or acquisitions as companies strive to maintain competitive advantages.
The analysis published in Clinical Ophthalmology suggests that OMNI was as effective at lowering IOP and reducing medication usage in advanced glaucoma as it was in mild and moderate glaucoma.
MENLO PARK, Calif., May 28, 2024 (GLOBE NEWSWIRE) -- Sight Sciences, Inc. (Nasdaq: SGHT) ("Sight Sciences" or the "Company"), an eyecare technology company focused on developing and commercializing innovative, interventional technologies intended to transform care and improve patients' lives, today announced the results as published in the journal Clinical Ophthalmology of a new analysis of the ROMEO (Retrospective, Observational, Multicenter Evaluation of OMNI) study data. This new analysis evaluated the association between the severity of glaucoma and the intraocular pressure ("IOP") and medication outcomes for patients treated with the OMNI Surgical System ("OMNI"). OMNI enables a procedure intended to restore aqueous outflow of glaucomatous eyes by addressing the three areas of outflow resistance associated with the disease.
The findings suggest that ab interno canaloplasty coupled with trabeculotomy using OMNI was as effective at lowering IOP and reducing medication usage in advanced glaucoma patients as it was in mild and moderate glaucoma patients. This data challenges the belief that advanced disease stage is a barrier to successful treatment outcomes for minimally invasive glaucoma surgery ("MIGS").
"There had been some debate about the efficacy of MIGS in advanced glaucoma patients, with speculation that prolonged disease may cause irreversible harm to the distal outflow pathway," said Dr. Jaime E. Dickerson, Jr., Vice President of Medical and Clinical Affairs at Sight Sciences. "The current study suggests that treatment with OMNI technology, which has a strong safety profile and proven durability, is still effective in patients with more extensive visual field damage."
ROMEO was an Institutional Review Board ("IRB") approved retrospective case series conducted at eleven ophthalmology practices in the United States. Participants were mainly primary open-angle glaucoma patients (122 of 129, or
Eyes were categorized based on visual field mean deviation ("MD"), with participants assigned to a group with severity rated as mild (n=79, median MD -2.7 dB), moderate (n=42, median MD -8.0 dB) or advanced (n=6, median MD -13.3). The study compared outcomes at 12 months.
Key findings reported in the study include:
- Significant reductions in both IOP and IOP-reducing medications were observed.
- The majority of eyes (
70% ) experienced a reduction in IOP at Month 12, with most achieving levels of 18 mmHg or less (92% ). - The percentage of IOP reduction was consistent across severity groups, with month 12 mean IOP ranging between 14 mmHg and 16 mmHg.
- Medication reductions were observed across all severity groups, with the majority of patients showing a reduction of at least 1 medication (
50% to69% ), indicating the effectiveness of the treatment approach. - Regression analysis found no significant relationship between month 12 IOP and visual field loss, suggesting treatment outcomes were consistent irrespective of disease severity.
"Clinical trials and real-world results continue to demonstrate favorable OMNI treatment outcomes across different stages of glaucoma," said Paul Badawi, Co-Founder and CEO of Sight Sciences. "These findings reinforce our dedication to offering effective treatment options for glaucoma patients at every stage of the disease and also fuel our initiatives to continue reimagining eyecare with transformative technology and an interventional mindset."
Authors and affiliations:
Jaime E. Dickerson Jr., PhD; Alison E. Harvey, PhD; and Reay H. Brown, MD, all from Sight Sciences.
Paper Reference:
Jamie E. Dickerson, Alison E. Harvey, Reay H. Brown, Ab Interno Canaloplasty and Trabeculotomy Outcomes for Mild, Moderate, and Advanced Open-Angle Glaucoma: A ROMEO Analysis, Clinical Ophthalmology, 2024:18
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 ("POAG"); 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 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") when used in conjunction with manual expression of the meibomian glands, 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 is a trademark 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.
© 2024 Sight Sciences. All rights reserved. 05/2024 OM-3212-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, 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 clinical outcomes and our initiatives to continue reimagining eyecare with transformative technology and an interventional mindset. 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.
Media contact:
pr@SightSciences.com
Investor contact:
Philip Taylor
Gilmartin Group
415.937.5406
Investor.Relations@SightSciences.com
FAQ
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