Microinvasive Glaucoma Surgery with the OMNI® Surgical System is Associated with Diminished Diurnal IOP Fluctuations, a Significant, Independent Risk Factor for Glaucoma Progression
Sight Sciences (Nasdaq: SGHT) announced significant data from the 12-month GEMINI clinical trial showing that the OMNI Surgical System effectively reduces intraocular pressure (IOP) and stabilizes daily IOP fluctuations in patients with open-angle glaucoma. The study included 149 patients, demonstrating that 95% achieved lower peak IOP post-surgery, with a 36% decrease in variability compared to preoperative levels. The results support the device’s potential to improve patient outcomes in glaucoma treatments, encouraging future regulatory developments.
- Statistically significant reduction in mean IOP in patients with mild to moderate open-angle glaucoma.
- 95% of patients experienced diminished peak IOP post-surgery compared to preoperative measurements.
- 36% reduction in daily IOP fluctuations observed, indicating a flattening of the diurnal curve.
- None.
12-Month OMNI data from the prospective, multicenter GEMINI clinical trial show statistically significant postoperative reductions in mean IOP and suppression of daily IOP fluctuations
MENLO PARK, Calif., Nov. 17, 2021 (GLOBE NEWSWIRE) -- Sight Sciences, Inc. (Nasdaq: SGHT), an eyecare technology company focused on creating innovative solutions intended to transform standards of care and improve patients’ lives, today announced publication in Clinical Ophthalmology of favorable data showing that microinvasive glaucoma surgery (MIGS) using the OMNI® Surgical System suppressed daily fluctuations in intraocular pressure (IOP) – a meaningful and independent risk factor for the progression of glaucoma.
OMNI is cleared by the U.S. Food and Drug Administration (FDA) and CE-Marked for canaloplasty followed by trabeculotomy to reduce IOP in adult patients with primary open-angle glaucoma (POAG) (FDA) and open-angle glaucoma (CE).* Sight Sciences intends to further develop OMNI and seek regulatory clearance for expanded indications.
The importance of IOP reduction to limit or halt disease progression is well known and has been demonstrated in landmark studies such as the Advanced Glaucoma Intervention Study (AGIS) and the Early Manifest Glaucoma Trial (EMGT). The importance of daily IOP fluctuation in glaucoma progression is also generally accepted. Results from the GEMINI study showed that MIGS using the OMNI Surgical System resulted in a significant reduction in overall mean IOP from baseline, and 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,
“Post hoc analysis of the GEMINI data suggests that ab-interno canaloplasty plus goniotomy using the OMNI Surgical System combined with cataract surgery has the potential to control IOP fluctuations, a known risk factor for the progression of glaucoma,” said Mark F. Pyfer, M.D., Northern Ophthalmic Associates, Jenkintown, Pa., GEMINI investigator and first author of the study. “We observed that when many of our GEMINI study patients returned for 12-month diurnal IOP monitoring off all medications, their IOP appeared stable throughout the day. This observation motivated our post hoc analysis of the GEMINI study data, showing that the 12-month variability of patients’ IOP measurements decreased significantly from preoperative levels, essentially “flattening” the diurnal curve during the daytime.”
The GEMINI study was a prospective, 12-month, multicenter study of 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. Patients were “washed out” of their pre-study IOP-lowering medications before surgery, and again at the 12-month endpoint, to ensure study results were not confounded by medication use.
“We believe this post hoc analysis of the GEMINI study is meaningful because it shows that OMNI not only lowers IOP by addressing all three points of resistance in the conventional pathway (trabecular meshwork, Schlemm’s canal, distal collector channels), but treatment with OMNI also decreased the magnitude of daily IOP fluctuations, known to be a significant and independent risk factor for disease progression,” said Paul Badawi, Co-Founder and CEO, Sight Sciences. “OMNI uniquely enables clinicians to perform canaloplasty followed by trabeculotomy and address all three points of resistance in the diseased conventional outflow pathway with a single device through a single clear corneal microincision. We believe, with this post hoc analysis, we are the first company to observe a ‘flattened diurnal curve,’ an important clinical finding that further supports OMNI’s differentiated clinical outcomes and our forward-thinking leadership in the MIGS category.”
About Sight Sciences
Founded in 2011, Sight Sciences develops and commercializes intelligently designed and engineered products that target the underlying causes of the world’s most prevalent eye diseases. The company currently markets two products, the OMNI® Surgical System and the TearCare® System. For more information, visit www.sightsciences.com.
About OMNI®
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. OMNI allows surgeons to access 360 degrees and all 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 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 31 global patents.
OMNI® is a registered trademark of Sight Sciences.
© 2021 Sight Sciences. All rights reserved.
Forward-Looking Statements
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Media contact:
Shay Smith
Health+Commerce
707.971.9779
shay@healthandcommerce.com
Investor contact:
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Gilmartin Group
415.937.5406
Investor.Relations@Sightsciences.com
FAQ
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What does the 36% reduction in IOP fluctuations mean for patients using OMNI according to Sight Sciences (SGHT)?
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