Sight Sciences, Inc. announced the results from a 12-month retrospective sub-analysis of IOP-lowering medication use following the three most commonly performed, FDA approved (or cleared) MIGS procedures in patients with mild stage glaucoma.
The study titled, “A Clinical Registry Study of Glaucoma Medication Use in Patients with Mild Glaucoma Severity After MIGS,” was presented on May 7 by Michael Mbagwu, MD, Adjunct Clinical Instructor of Ophthalmology at Stanford University School of Medicine and Senior Medical Director of Verana Health, during the American Society of Cataract and Refractive Surgery annual meeting in San Diego, California.
Analysis included 16,789 patients in 4 different cohorts: 1) procedures enabled by OMNI Surgical System technology in combination with cataract 2) iStent Inject in combination with cataract 3) Hydrus in combination with cataract or 4) cataract surgery alone.
Analysis of medical records of 16,789 mild glaucoma patients in the American Academy of Ophthalmology (Academy) IRIS Registry (Intelligent Research in Sight), one of the largest specialty society clinical data registries in all of medicine, showed that patients in the OMNI technology cohort experienced the greatest average medication reduction with a mean reduction from baseline of 1.01 glaucoma medications at 12 months post-operatively.
This was a statistically significantly greater medication reduction (p<0.001) when compared to the medication reductions observed for the iStent Inject in combination with cataract surgery as well as cataract surgery alone. The retrospective analysis was performed in partnership with Verana Health, the exclusive end-to-end data curation and analytics partner for the Academy’s IRIS Registry.
“We hope the real-world clinical data we are presenting at the ASCRS annual meeting will encourage stakeholders to reevaluate treatment paradigms for glaucoma patients – whether it be patients seeking to reduce their daily medication burden, surgeons looking for clinically effective options, or payors interested in cost-effective treatments,” said Dr. Mbagwu. “Given the limitations and challenges inherent in topical IOP lowering medications, such as long-term adherence and adverse events that contribute towards discontinuation, the meaningful reduction in medication usage for patients with mild glaucoma with the OMNI technology is significant. As physicians, we should be open to tailoring treatment options in a patient specific way, including offering MIGS as a means for both IOP and medication reduction. This sub-analysis shows differential outcomes for the most commonly used MIGS in the real-world setting and should inform future conversations.”
There was no statistical significance in the average medication reduction between Hydrus and Omni (ns, p=.131)
The collaboration between Sight Sciences and Verana Health reviewed real-world clinical outcomes data from MIGS devices and procedures within the IRIS Registry database from 2018-2020. The study’s primary endpoint evaluated and compared IOP and medication reduction among FDA-approved or cleared MIGS used in combination with cataract surgery as well as cataract procedures alone at pre-specified time intervals up to 24 months.
“This is the first large-scale comparative study leveraging the IRIS Registry with the most comprehensive MIGS dataset ever assembled using pharmacy claims data to understand glaucoma medication utilization, and tells a very compelling story in terms of how the most commonly used MIGS procedures perform in the real world. We believe such reliable, real world, and large-scale third party de-identified data from the Academy’s database will be very informative to MIGS decision-making going forward and we look forward to continuing to educate physicians and payors that outflow restorative procedures enabled by our technology can deliver meaningful and sustained reductions in intraocular pressure and medication use,” said Paul Badawi, co-founder and CEO of Sight Sciences. “We look forward to presenting additional data from this large-scale project at upcoming medical meetings and sharing the comprehensive data set in a leading peer reviewed publication in 2023.”
The IRIS Registry is the first comprehensive eye disease clinical registry in the United States. Launched in 2014, it has amassed over 490 million billable patient visits and 79 million unique de-identified patients from nearly 56 electronic health records systems (EHRs) and more than 15,000 ophthalmologists and other eye care professionals across the U.S., as of April 1, 2023.
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 current portfolio includes multiple technologies including the OMNI Surgical System, SION Surgical Instrument, and TearCare.
Visit SightSciences.com for more information.
About the OMNI Surgical System
The OMNI Surgical System technology is a handheld, single-use therapeutic technology for minimally invasive glaucoma surgery (MIGS). OMNI technology enables surgeons to access 360 degrees and 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's FDA-cleared indication is 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 technology is protected by a global patent portfolio including 32 issued patents worldwide. OMNI is a registered trademark of Sight Sciences.
Visit www.OMNIsurgical.com for more information.