The study, titled “A Clinical Registry Study of Glaucoma Medication Use in Patients with Mild Glaucoma Severity After MIGS,” will be presented Sunday by Michael Mbagwu, MD, at the American Society of Cataract and Refractive Surgery annual meeting in San Diego, California.
Sight Sciences Inc. today 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.
According to the company, 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.
The study, titled “A Clinical Registry Study of Glaucoma Medication Use in Patients with Mild Glaucoma Severity After MIGS,” will be presented Sunday 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.
According to a Sight Sciences news release, analysis of medical records of 16,789 mild glaucoma patients in the American Academy of Ophthalmology 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 alone¹. 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.
Mbagwu said it was hoped that real-world clinical data being presented 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.
“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,” Mbagwu explained in the news release. “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.”
According to the company, 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.
Moreover, 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.
Paul Badawi, co-founder and CEO of Sight Sciences, noted in the release the research marked 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,” Badawi said in a statement. “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.
¹ There was no statistical significance in the average medication reduction between Hydrus and Omni (ns, p=.131)