Sight Sciences Announces Long-Term Safety and Effectiveness Data of Standalone Use of the Omni Surgical System in Patients with Open Angle Glaucoma
Sight Sciences announced 36-month post-surgery follow-up results of the Omni Surgical System. The data demonstrate 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 a company news release.
The study showed that canaloplasty followed by trabeculotomy using the Omni Surgical System achieved a mean reduction in 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 3 years, suggesting robust durable effectiveness of the Omni 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,” Karsten Klabe, MD, Principal Investigator, Head Surgeon of Breyer, Kaymak & Klabe Augenchirurgie, said in a company news release. “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 clinical observation included 38 eyes from 26 patients with OAG treated with the Omni 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.
The data results were presented in June at the 15th European Glaucoma Society (EGS) Congress in Athens, Greece.