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Sight Sciences reveals real-world data that show the safety, efficacy, and durability of effect of its Omni Surgical System for use in a standalone procedure to reduce IOP and medication burden.
Sight Sciences Inc. has revealed favorable 24-month outcomes from a single center open-label study of its surgical system (OMNI) conducted in Germany.
The findings were published in Clinical Ophthalmology.1
The surgical system is cleared by the 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).
According to the company, it intends to further develop the surgical system, and to seek regulatory clearance, for expanded indications.
Results from the study, conducted and co-authored by Karsten Klabe, MD, and Hakan Kaymak, MD, report that use of the surgical system to perform a standalone MIGS procedure (not combined with cataract surgery) in mild to moderate open-angle glaucoma resulted in statistically significant reductions in both IOP and IOP-lowering medication use at 24 months.
The study included long-term (24-month) outcomes from 38 eyes of 27 subjects with open-angle glaucoma. Klabe, the lead author, directly performed canaloplasty followed by trabeculotomy on each patient using the surgical system at his practice in Düsseldorf, Germany.
According to Klabe, by comprehensively addressing the entire conventional outflow pathway circumferentially with the surgical system, clinicians can address outflow resistance wherever it
“OMNI offers clinicians a safe, effective and minimally invasive option for treating both phakic and pseudophakic patients outside of cataract surgery,” Klabe said. “I am excited to see these outcomes further validate my clinical experience and success using OMNI on a standalone basis.”
Mean baseline IOP in the study decreased from 24.6 mmHg preoperatively to 14.7 and 14.9 mm Hg at months 12 and 24, respectively, reductions of approximately 10 mm Hg or approximately 40%.
All subjects in the study, and 100% of eMean baseline IOP-lowering medication also decreased from 1.9 average medications per patient to 0.5 medications at month 24.
At 24 months, nearly 60% of eyes were free of IOP-lowering medication. Both IOP and IOP-lowering medication reduction outcomes in the study were statistically significant (p<.0001).
Importantly, the study cohort included primary open-angle glaucoma (71%) and pseudoexfoliation glaucoma (29%) patients, as well as phakic (74%) and pseudophakic (eye with an intraocular lens; 26%) eyes.
Outcomes for these subgroups were observed to be similar to the overall results. Adverse events were observed to be consistent with those expected in angle or minimally invasive glaucoma surgery (MIGS).
The most frequent was transient postoperative hyphema (17 eyes, 44%), in all cases 1 mm or less.
Other adverse events included choroidal effusion (three eyes, 7.9%), anterior synechiae (two eyes, 5.3%), and transient lens-cornea touch associated with shallow anterior chamber (seen in one eye).
All of these events were reported to have resolved spontaneously without intervention and with no sequelae. No secondary procedures were required to address adverse events.
Paul Badawi, co-founder and CEO of Sight Sciences, said in a statement that the results are particularly meaningful because they support the long-term benefits of the surgical system for use in a standalone procedure, regardless of lens status, to reduce IOP and the burden of medication in adult patients with POAG.
“We believe that OMNI uniquely enables clinicians to perform two implant-free procedures to address all three points of resistance in the diseased conventional outflow pathway with a single device through a single clear corneal microincision,” he said in a statement. “We believe that these results may support OMNI’s potential for expanded indications in other glaucoma patient populations.”
1. Klabe K, Kaymak H. Standalone Trabeculotomy and Viscodilation of Schlemm’s Canal and Collector Channels in Open-Angle Glaucoma Using the OMNI Surgical System: 24-Month Outcomes. Published July 2021: 3121-3129. doi.org/10.2147/OPTH.S325394