Sight Sciences Announces Publication of 2-Year Outcomes of Standalone Use of the OMNI Surgical System
Sight Sciences announced publication in Clinical Ophthalhmology of favorable 24-month outcomes from a single center open-label study of the OMNI Surgical System conducted in Germany.
OMNI 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).* Sight Sciences intends to further develop OMNI, 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 OMNI 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. First author, Dr. Klabe, directly performed canaloplasty followed by trabeculotomy on each patient using OMNI at his practice in Düsseldorf, Germany.
Mean baseline IOP in the study decreased from 24.6 mmHg preoperatively to 14.7 and 14.9 mmHg at months 12 and 24, respectively, reductions of approximately 10 mmHg or approximately 40%. All subjects in the study, and 100% of eyes, had at least a 20% IOP reduction at 24 months. Mean 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.
“These results are particularly meaningful because they support the long-term benefits of OMNI for use in a standalone procedure, regardless of lens status, to reduce IOP and the burden of medication in adult patients with POAG,” Paul Badawi, Co-Founder and CEO, Sight Sciences, said in a company news release. “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. We believe that these results may support OMNI’s potential for expanded indications in other glaucoma patient populations.”
“By comprehensively addressing the entire conventional outflow pathway circumferentially with OMNI, clinicians can address outflow resistance wherever it occurs,” said Dr. Klabe. “OMNI offers clinicians a safe, effective and minimally invasive option for treating both phakic and pseudophakic patients outside of cataract surgery. I’m excited to see these outcomes further validate my clinical experience and success using OMNI on a standalone basis.”