According to the company, a study shows the non-implantable minimally invasive glaucoma surgery effectively reduces IOP and reduces need for IOP-lowering medications in patients diagnosed with open-angle glaucoma.
Sight Sciences Inc. today announced 36-month post-surgery follow-up results of its surgical system (Omni). The data demonstrates that the OMNI Surgical System delivers safe, consistent, and durable results in adult patients with open-angle glaucoma (OAG) on a standalone basis.
According to the company, the study showed that canaloplasty followed by trabeculotomy using the surgical system achieved a mean reduction in intraocular pressure (IOP) of at least 20 percent for all 26 patients (38 eyes) at 36 months follow-up. At 12, 24 and 36 months after surgery, patients’ mean preoperative IOP post medication washout decreased from 24.6±3.2 mmHg to 14.5±1.7 mmHg, 14.2±2.0 mmHg and 15.0±1.9, respectively. The mean number of IOP-lowering medications was reduced from 1.9±0.7 to 0.4±0.6, 0.6±0.7 and 0.5±0.7 at 12, 24 and 36-months.
The postoperative IOP and medication use reduction at 12 months remained consistent over three years, suggesting robust durable effectiveness of the surgical system when used as a standalone intervention either in phakic or pseudophakic eyes. Only a minimal number of adverse events were reported, all of which resolved without any intervention except one eye required secondary IOP lowering intervention.
“As we continue to evaluate this patient group with the OMNI Surgical System, the results consistently show the minimally invasive procedure has the potential to offer long-standing benefits for patients with open-angle glaucoma,” said Karsten Klabe, MD, Principal Investigator, head surgeon of Breyer, Kaymak & Klabe Augenchirurgie. “Most patients experienced an IOP reduction of at least 20 percent and required significantly less medication, meeting the study's objective. By effectively reducing IOP and the medication burden, the OMNI Surgical System is transforming how glaucoma is cared for in both combination cataract and standalone glaucoma patients.”
The company noted in its news release that the clinical observation included 38 eyes from 26 patients with OAG treated with the surgical system. Follow-up visits were done on day 1, week 1 and months 1, 3, 6, 12, 18, 24, 30 and 36 after surgery. This trial is an extension of 24-month data that was published in Clinical Ophthalmology in June 2021.
Paul Badawi, co-founder and CEO of Sight Sciences, noted in the news release that the company’s surgical system is supported by a robust clinical development program, which includes this treatment evaluation over 3 years in patients with open-angle glaucoma.
“These results highlight the long-term effectiveness and strong safety profile of the OMNI Surgical System,” Badawi explained in the release. “This non-implantable procedure has shown effectiveness without the known IOP-lowering assistance of cataract surgery. We look forward to ongoing data collection and evaluating the durability at further intervals post-microinvasive canal surgery with OMNI.”
The data results were presented in June at the 15th European Glaucoma Society (EGS) Congress in Athens, Greece.
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