Sight Sciences’ OMNI® Surgical System Reduces IOP, Daily Fluctuations in IOP and Medication Use, as Shown in Newly Published 12-Month Clinical Data
- Suppression of diurnal, or daily, fluctuations in IOP, is a significant and independent risk factor for the progression of glaucoma
- These 12-month outcomes were also confirmed by results from a subset of the study, assessing the Hispanic patient population
MENLO PARK, Calif., May 31, 2022 (GLOBE NEWSWIRE) -- Sight Sciences, Inc. (Nasdaq: SGHT), an eyecare technology company focused on developing and commercializing innovative solutions intended to transform care and improve patients’ lives, today announced publication in Clinical Ophthalmology of its 12-month outcomes in the GEMINI study, including results from a Hispanic population subset. The final study results demonstrated that canaloplasty and trabeculotomy performed as an implant-free minimally invasive glaucoma surgery (MIGS) using the OMNI® Surgical System in conjunction with cataract surgery significantly reduced unmedicated mean diurnal intraocular pressure (IOP), medication use and daily fluctuations in IOP in patients with open-angle glaucoma (OAG).
The GEMINI study exhibited a mean unmedicated diurnal IOP reduction of 35%, from 23.8 (3.1) mmHg at baseline to 15.6 (4.0) at month 12 and a medication reduction (before washout) of 80% from 1.8 (0.9) at baseline to 0.4 (0.9) at month 12. At month 12, 84.2% of eyes achieved IOP reductions > 20% from baseline, 80% of eyes were medication-free, and 76% of eyes achieved IOP between 6– 18 mmHg, inclusive. 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, 95% of patients had a diminished peak IOP postoperatively when compared to preoperative measurements. The difference between “high” and “low” IOP at 12 months reduced an average of 36% compared to preoperative measurements. Suppression of diurnal, or daily, fluctuations in IOP, is a significant and independent risk factor for the progression of glaucoma.
In the Hispanic population subset of the GEMINI study, the unmedicated mean diurnal IOP was reduced from 22.8 mmHg (2.5) to 14.9 (3.6) at 12 months – also a 35% reduction, as with the larger study. Data show that 97% of patients had an IOP reduction, and 85% had ≥20% reduction. At month 12, medications were reduced from 0.43 to 0.15 (P<0.001) and the majority (87%) of patients required no medications. As the Hispanic population is the second largest racial or ethnic demographic in the U.S.1, with a higher predisposition to glaucoma2, this published data provides visibility of results from MIGS, specifically the OMNI Surgical System, that corroborate the larger study findings while providing specific data for the Hispanic population, which has been limited up to this point.
“Effective treatment backed by robust clinical evidence is critical for eyecare professionals who treat patients with glaucoma. We now have 12 months of prospective, multicenter data showing 360° canaloplasty and 180° trabeculotomy performed with the OMNI Surgical System at the time of cataract surgery significantly reduced unmedicated mean diurnal IOP and medication use at 12 months postoperatively,” said Mark J. Gallardo, MD, El Paso Eye Surgeons. “This conclusion was also observed in the Hispanic population, where there’s increased prevalence of glaucoma with a higher proportion who are undiagnosed. These results are particularly encouraging for eye care professionals and their patients who are ultimately all looking for a treatment option that may reduce the medication burden and offer sustained results.”
The GEMINI study was a prospective, 12-month, multicenter study to measure 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. The Hispanic (Northern Mexico/mestizo) open-angle glaucoma population encompassed 39 subjects from a tertiary referral glaucoma center in El Paso, Texas. The study had an excellent safety profile and no serious adverse events.
"The GEMINI study is yet another testament to the safety, efficacy, and durability of our micro-invasive, implant-free OMNI procedure. By circumferentially and comprehensively addressing all three points of resistance in the conventional outflow pathway, OMNI is redefining MIGS and elevating the clinical expectations within the category," said Paul Badawi, Co-Founder and CEO, Sight Sciences. "Sight Sciences is committed to providing the eyecare professional community and the patients they serve with solutions to help limit the progression of glaucoma, the world's leading cause of irreversible blindess.3”
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 Company’s TearCare® System 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), enabling office-based clearance of gland obstructions by physicians to address the leading cause of dry eye disease.
For more information, visit www.sightsciences.com.
About the OMNI® Surgical System
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.
Through a single clear corneal microincision, OMNI® allows surgeons to access all 360 degrees of Schlemm’s canal and treat all three sources of outflow resistance within the eye’s diseased conventional outflow pathway (trabecular meshwork, Schlemm’s canal, and collector channels).
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 a global patent portfolio including 32 issued patents worldwide.
OMNI® is a registered trademark of Sight Sciences.
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- Noe-Bustamante, Luis, et al. “U.S. Hispanic Population Surpassed 60 Million in 2019, but Growth Has Slowed.” Pew Research Center, Pew Research Center, 2020
- Varma R, Ying-Lai M, Francis BA, et al. Prevalence of open-angle glaucoma and ocular hypertension in Latinos: the Los Angeles Latino Eye Study. Ophthalmology. 2004
- Centers for Disease Control and Prevention. 2020